Back to resultsA Study of Crenezumab Versus Placebo to Evaluate the Efficacy and Safety in Participants With Prodromal to Mild Alzheimer's Disease (AD) (CREAD 2)
Primary Purpose
Alzheimer's Disease
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Crenezumab
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer's Disease
Eligibility Criteria
Inclusion Criteria:
- Weight between 40 and 120 kilograms (Kg) inclusive
- Availability of a person (referred to as the "caregiver") who in the investigator's judgment:
- Has frequent and sufficient contact with the participant to be able to provide accurate information regarding the participant's cognitive and functional abilities, agrees to provide information at clinic visits (which require partner input for scale completion), signs the necessary consent form, and has sufficient cognitive capacity to accurately report upon the participant's behavior and cognitive and functional abilities
- Fluency in the language of the tests used at the study site
- Adequate visual and auditory acuity, in the investigator's judgment, sufficient to perform the neuropsychological testing (eye glasses and hearing aids are permitted)
- Evidence of the AD pathological process, by a positive amyloid assessment either on cerebrospinal fluid (CSF) amyloid beta 1-42 levels as measured on the Elecsys beta-amyloid(1-42) test system or amyloid PET scan by qualitative read by the core/central PET laboratory
- Demonstrated abnormal memory function at screening (up to 4 weeks before screening begins) or screening (FCSRT cueing index =<0.67 AND free recall =<27)
- Screening mini mental state examination (MMSE) score of greater than or equal to (>=) 22 points and Clinical Dementia Rating-Global Score (CDR-GS) of 0.5 or 1.0
- Meets National Institute on Aging/Alzheimer's Association (NIAAA) core clinical criteria for probable AD dementia or prodromal AD (consistent with the NIAAA diagnostic criteria and guidelines for mild cognitive impairment (MCI)
- If receiving symptomatic AD medications, the dosing regimen must have been stable for 3 months prior to screening
- Participant must have completed at least 6 years of formal education after the age of 5 years
Exclusion Criteria:
- Any evidence of a condition other than AD that may affect cognition such as other dementias, stroke, brain damage, autoimmune disorders (e.g. multiple sclerosis) or infections with neurological sequelae.
- History of major psychiatric illness such as schizophrenia or major depression (if not considered in remission)
- At risk of suicide in the opinion of the investigator
- Any abnormal MRI findings, such as presence of cerebral vascular pathology, cortical stroke, etc or inability to tolerate MRI procedures or contraindication to MRI
- Unstable or clinically significant cardiovascular (e.g., myocardial infarction), kidney or liver disease
- Uncontrolled hypertension
- Screening hemoglobin A1c (HbA1C) >8%
- Poor peripheral venous access
- History of cancer except:
If considered to be cured or If not being actively treated with anti-cancer therapy or radiotherapy
- Known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins
Sites / Locations
- Imaging End Points Clinical Research
- Health Initiatives Research, PLLC
- Clinical Trials Inc.
- Neuro-Therapeutics Inc.
- Desert Valley Medical Group
- Anderson Clinical Research, Inc.
- University of California, Davis; Alzheimers Disease Center, Department of Neurology
- UCSF - Memory and Aging Center
- MCB Clinical Research Centers
- Research Center for Clinical Studies, Inc.
- KI Health Partners, LLC; New England Institute for Clinical Research
- Georgetown University Hospital
- JEM Research LLC
- Bradenton Research Center
- Neuropsychiatric Research; Center of Southwest Florida
- Alzheimer's Research and Treatment Center
- Renstar Medical Research
- Bioclinica Research
- Progressive Medical Research
- Columbus Memory Center
- Lake Charles Clinical Trials, LLC
- Alzheimers Disease Center; Neurology
- Health Partners Institute for Education and Research
- Precise Research Centers
- University of Nebraska Medical Center; Dept of Neurological Sciences
- Cleveland Clinic Lou Ruvo; Center for Brain Research
- The Cognitive and Research Center of New Jersey
- Advanced Memory Research Institute of NJ
- Columbia University Medical Center
- Burke Rehabilitation Hospital
- Behavioral Health Research
- Wake Research Associates
- University of Cincinnati; Department of Psychiatry and Behavioral Neuroscience
- Ohio State University; College of Medicine
- Dayton Center for Neuro Disorders
- Summit Research Network Inc.
- Thomas Jefferson University
- Northeastern Pennsylvania Memory
- Abington Neurological Associates
- Neurology Clinic PC
- Senior Adults Specialty Research
- Gadolin Research, LLC
- Texas Neurology PA
- Kerwin Research Center, LLC
- Alzheimers Disease & Memory Disorders Center; Department of Neurology Baylor College of Medicine
- Clinical Trials of Texas, Inc
- Sentara Medical Group
- National Clinical Research Inc.-Richmond
- Hospital Italiano
- Universidad Maimonides
- DAMIC
- St Vincent's Hospital Sydney
- Central Coast Neurosciences Research
- Hornsby Ku-ring-gai Hospital; Division of Rehabilitation & Aged Care
- The Queen Elizabeth Hospital; Neurology
- AZ Sint Jan
- AZ Groeninge
- UZ Leuven Gasthuisberg
- CCBR - Brasilia
- Hospital das Clinicas - UFMG
- Instituto de Neurologia de Curitiba
- Centro Psiquiatria Sandra Ruschel Ltda
- Hospital das Clinicas - UFRGS
- Clínica Dr. Norton Sayeg LTDA - EPP
- OCT Research ULC
- Vancouver Island Health Authority
- True North Clinical Research-Halifax
- True North Clinical Research Kentville
- Providence Care; Mental Health Services
- Parkwood Hospital; Geriatric Medicine
- Kawartha Centre - Redefining Healthy Aging
- The Centre for Memory and Aging
- St. Michael's Hospital
- Devonshire Clinical Research Inc.
- Clinique Neuro Rive-Sud
- ALPHA Recherche Clinique
- Beijing Union Hospital
- Tianjin Medical University General Hospital
- Aarhus Universitetshospital, Neurologisk Afdeling F, Demensklinikken
- Rigshospitalet, Hukommelsesklinikken
- Laane-Tallinna Keskhaigla
- Hopital Pellegrin; Cmrr Aquitaine
- Hôpital de Jour du Centre pour Personnes Âgées; Louis Pasteur Neurologie
- Hopital Roger Salengro; Service de Neurologie
- CHU de Limoges Hopital Dupuytren; Service de Medecine Geriatrique
- Hopital Broca
- CH Pitie Salpetriere; IM2A
- Hôpital Maison Blanche
- CHU Rennes - Hopital Pontchaillou
- CHU de Rouen Hopital; Service de Neurologie
- Hop Guillaume Et Rene Laennec; Cmrr St Herblain
- Hopital des Charpennes
- ECRC Experimental and Clinical Research Center, Charité Campus Berlin Buch, Memory Clinic
- Klinikum Joh.Wolfg.Goethe-UNI Zentrum d. Psychiatrie Klinik f. Psychiatrie Psychosomatik
- Universitätsklinikum Freiburg, Zentrum für Geriatrie und Gerontologie
- Universitätsklinikum des Saarlandes Klinik f. Psychiatrie und Psychotherapie
- PANAKEIA - Arzneimittelforschung Leipzig GmbH
- Pharmakologisches Studienzentrum
- Klinikum rechts der Isar der TU München; Klinik für Psychiatrie und Psychotherapie
- Rambam Medical Center
- Sheba Medical Center; Psychiatry Department
- Tel Aviv Sourasky Medical Center; Department of Neurology
- Azienda Ospedaliera Universitaria Policlinico Tor Vergata; Neurologia
- Umberto I Policlinico di Roma-Università di Roma La Sapienza
- Ospedale San Giovanni Calibita Fatebenefratell;Neurologia
- IRCCS "Centro S. Giovanni di Dio" Fatebenefratelli -UO Alzheimer
- Irccs Multimedica Santa Maria; Unita' Di Neurologia
- IRCCS Ospedale San Raffaele; Centro Disturbi della Memoria
- Fondazione IRCCS Istituto Nazionale Neurologico Besta; UO Neuropatologia
- Ospedale S. Maria Nascente; Fondazione Don Gnocchi; Dip. Neurologia Riabilitativa
- Ospedale Casati Passirana di Rho; Centro Regionale Alzheimer
- IRCCS Neuromed; Neurologia I-Centro studio e cura delle demenze e UVA
- AO Città della Salute e della Scienza Osp.S.Giov.Battista Molinette; SC Geriatria
- A.O. Universitaria Pisana; Neurologia
- National Center for Geriatrics and Gerontology
- Inage Neurology and Memory Clinic
- Fukuoka Mirai Hospital
- National Hospital Organization Hiroshima-Nishi Medical Center
- Tsukazaki Hospital
- Iwate Medical University Hospital
- Kagawa Prefectural Central Hospital
- Fujisawa City Hospital
- National Hospital Organization Sagamihara National Hospital
- Ijinkai Takeda General Hospital
- Rakuwakai Otowarehabilitation Hospital
- National Hospital Organization Matsumoto Medical Center
- Katayama Medical Clinic
- Osaka University Hospital
- Asakayama General Hospital
- NHO Shizuoka Institute of Epilepsy and Neurological Disorders
- Kanto Central Hospital
- Tokyo Medical University Hospital
- Shinjuku Research Park Clinic
- Tokyo Metropolitan Geriatric Hospital
- National Center of Neurology and Psychiatry
- Tokyo Medical University Hachioji Medical Center
- Dong-A University Hospital
- Gachon University Gil Medical Center
- Seoul National University Bundang Hospital
- Seoul National University Hospital
- Hanyang University Seoul Hospital
- Konkuk University Medical Center
- Samsung Medical Center
- Seoul St Mary's Hospital
- Borame Medical Center
- Akershus universitetssykehus HF; Nevroklinikken S203
- Oslo universitetssykehus HF Ullevål sykehus; Hukommelsesklinikken
- Clinica Internacional; Unidad De Investigacion
- Hospital Nacional Dos de Mayo; Unidad de Investigacion de Neurologia
- NZOZ Dom Sue Ryder
- Centrum Medyczne Euromedis Sp. z o.o.
- Centrum Medyczne NeuroProtect
- NZOZ WCA
- Hospital de Braga; Servico de Neurologia
- HUC; Servico de Neurologia
- Hospital Pedro Hispano; Servico de Neurologia
- Hospital Geral de Santo Antonio; Servico de Neurologia
- LLC Baltic Medicine
- State Healthcare Institution of Sverdlovsk Region Sverdlovsk Regional Clinical Psychiatric Hospita
- State Autonomous Healthcare Institution "Republican Clinical Neurological Center
- State autonomous institution of healthcare Inter-regional clinical and diagnostic center
- Institution of RAMS (Mental Health Research Center of RAMS)
- City Clinical Psychiatry Hospital #1
- St Nicolas Psychiatric Hospital; Chair of Psychiatry and Narcology of St. Petersburg Medical Academy
- Nebbiolo Center for Clinical Trials
- Clinic for Mental disorders Dr Laza Lazarevic
- Neurology clinic, Clinical Center of Serbia
- Clinic for neurology, Clinical Center Kragujevac
- Private Practice; the Osteoporosis Clinic
- Hospital General Universitario de Elche; Servicio de Neurología
- Fundació ACE
- Hospital General De Catalunya; Servicio de Neurologia
- Hospital Mutua De Terrasa; Servicio de Neurologia
- Hospital Virgen del Puerto. Servicio de Neurología
- Hospital Universitario Marques de Valdecilla; Servicio de Neurología
- Hospital Santa Caterina, Unitat de Valoració de la memoria i les demencies
- Policlínica Guipuzkoa; Servicio de Neurología
- Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Neurologia
- Hospital San Pedro; Servicio de Neurología
- Hospital Quiron de Madrid; Servicio de Neurologia
- Clinica Universitaria de Navarra; Servicio de Neurología
- CAE Oroitu
- Hospital Perpetuo Socorro, Servicio de Geriatria
- Hospital de la Santa Creu i Sant Pau; Servicio de Neurologia
- Hospital Universitario de Burgos. Servicio de Neurología
- Hospital la Magdalena; Servicio de Neurologia
- Hospital Universitario Reina Sofia; Servicio de Neurologia
- Hospital Ramon y Cajal; Servicio de Neurologia
- Complejo Asistencial Universitario de Salamanca; Servicio de Psiquiatría; CSM La Alamedilla
- Hospital Universitario Virgen Macarena; Servicio de Neurologia
- Skånes Universitetssjukhus Malmö, Minneskliniken
- Sahlgrenska Academy University,Neuroscience and Physiology;Departmt of Psychiatry and Neurochemistry
- Changhua Christian Hospital; Neurology
- Kaohsiung Medical University Hospital; Neurology
- Taipei Medical University - Shuang Ho Hospital - Neurology
- National Taiwan University Hospital; Neurology
- Chang Gung Memorial Foundation - Linkou - Neurology
- Hacettepe University Medical Faculty; Neurology
- Istanbul University Istanbul School of Medicine; Neurology
- Ondokuz Mayis Univ. Med. Fac.; Neurology
- The Fritchie Centre, Charlton Lane Centre, Charlon Lane, Leckhampton; The Fritchie Centre
- Surrey and Borders NHS Foundation Trust; Brain Science Research Unit
- Sussex Partnership NHS Foundation Trust; Cognitive Treatment and Research unit
- Ninewells Hospital
- NHS Lothian - Western General Hospital; NHS Lothian - Western General Hospital
- Queen Elizabeth University Hospital; Clinical Research Facility
- RE:Cognition Health
- Charing Cross Hospital; Imperial Memory Unit, Level 10 West
- Manchester Royal Infirmary
- John Radcliffe Hospital
- University Southampton NHS Foundation Trust; Wessex Neurologica Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Crenezumab
Arm Description
Participants received intravenous (IV) infusion of Placebo every 4 weeks (Q4W) for 100 weeks.
Participants received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W) for 100 weeks.
Outcomes
Primary Outcome Measures
Change From Baseline to Week 77 in Clinical Dementia Rating-Sum of Boxes (CDR-SB) Scale Score
The CDR-SB rates impairment in 6 categories (memory, orientation, judgement and problem solving, community affairs, home and hobbies and personal care) on a 5-point scale in which no impairment = 0, questionable impairment = 0.5 and mild, moderate and severe impairment = 1, 2 and 3 respectively. The score range is from 0 to 18 with a high score indicating a high disease severity. The difference in mean change from Baseline to Week 77 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline for this primary endpoint. Data after 29 January 2019 are censored for the primary and secondary efficacy analyses to avoid potential biases due to investigators, participants, raters, etc. being potentially influenced by early closure of the study due to lack of efficacy.
Secondary Outcome Measures
Change From Baseline to Week 77 in Alzheimer's Disease Assessment Scale-Cognition 13 (ADAS-Cog-13) Subscale Score
The ADAS-Cog-13 assesses multiple cognitive domains including memory, comprehension, praxis, orientation, and spontaneous speech. Most of these are assessed by tests although some are rated by the clinician on a 5-point scale. The ADAS-Cog-13 is the ADAS-Cog-11 with 2 further items: delayed word recall and total digit cancellation. The score range for ADAS-Cog-13 is from 0 to 85 with high scores representing severe dysfunction. The difference in mean change from Baseline to Week 77 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline.
Change From Baseline to Week 77 in Alzheimer's Disease Assessment Scale-Cognition 11 (ADAS-Cog-11) Subscale Score
The ADAS-Cog-11 assesses multiple cognitive domains including memory, comprehension, praxis, orientation, and spontaneous speech. Most of these are assessed by tests although some are rated by the clinician on a 5-point scale. The score range for ADAS-Cog-11 is from 0 to 70 with high scores representing severe dysfunction. The difference in mean change from Baseline to Week 77 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline.
Change From Baseline to Week 77 on Severity of Dementia, Assessed Using the CDR-Global Score (CDR-GS)
The CDR-GS represents a semi-structured interview which rates impairment in 6 categories (memory, orientation, judgement and problem solving, community affairs, home and hobbies, and personal care) on a 5-point scale in which CDR 0 = no dementia and CDR 0.5, 1, 2 or 3 = questionable, mild, moderate or severe dementia respectively. The range in scores for the CDR-GS is from 0 to 3 and a high score on the CDR-GS would indicate a high disease severity. The difference in mean change from Baseline to Week 77 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline.
Change From Baseline to Week 77 on Severity of Dementia, Assessed Using the Mini Mental State Evaluation (MMSE)
The MMSE is a set of standardized questions used to evaluate possible cognitive impairment and help stage the severity level of this impairment. The questions target 6 areas: orientation, registration, attention, short-term recall, language and constructional praxis/visuospatial abilities. The scores on the MMSE range from 0 to 30, with higher scores indicating better function. The difference in mean change from Baseline to Week 77 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline.
Change From Baseline to Week 77 on Function as Assessed by (ADCS-ADL) Total Score
The ADCS-ADL (Alzheimer's Disease Cooperative Study-Activities of Daily Living) is the scale most widely used to assess functional outcomes in participants with AD. The ADCS-ADL covers both basic ADL (e.g., eating and toileting) and more complex 'instrumental' ADL or iADL (e.g., using the telephone, managing finances and preparing a meal). The ADCS-ADL consists of 23 questions with a score range of 0 to 78 where a higher score represents better function. The difference in mean change from Baseline to Week 77 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline.
Change From Baseline to Week 77 on Function as Assessed by (ADCS-iADL) Instrumental Score
The ADCS-iADL (Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living) measures activities such as using the telephone, managing finances and preparing a meal. The ADCS-iADL consists of 16 questions with a score range of 0 to 56 where a higher score represents better function. The difference in mean change from Baseline to Week 77 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline.
Change From Baseline to Week 77 on Function as Assessed by the Functional Activities Questionnaire (FAQ) Total Score
The Functional Activities Questionnaire (FAQ) is an instrument consisting of 10 items and assesses instrumental, social and cognitive functioning. The score range is from 0 to 30 with higher scores representing higher impairment. The difference in mean change from Baseline to Week 77 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline.
Change From Baseline to Week 77 on a Measure of Dependence Level Assessed From the ADCS-ADL Score
The ADCS-ADL (Alzheimer's Disease Cooperative Study-Activities of Daily Living) is the scale most widely used to assess functional outcomes in participants with AD. The ADCS-ADL covers both basic ADL (e.g., eating and toileting) and more complex 'instrumental' ADL or iADL (e.g., using the telephone, managing finances and preparing a meal). The ADCS-ADL consists of 23 questions with a score range of 0 to 78 where a higher score represents better function. The difference in mean change from Baseline to Week 77 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline.
Change From Baseline to Week 53 on Behavior in Neuropsychiatric Inventory Questionnaire (NPI-Q) Total Score
The NPI-Q evaluates 12 neuropsychiatric disturbances common in dementia: delusions, hallucinations, agitation, dysphoria, anxiety, apathy, irritability, euphoria, disinhibition, aberrant motor behavior, night-time behavioral disturbances and appetite/eating abnormalities. The severity of each neuropsychiatric symptom is rated on a 3-point scale (mild, moderate and marked). The total severity score range is from 0 to 36 with higher scores representing higher severity. Difference in mean change from Baseline to Week 53 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures adjusting for disease severity, APOEe4 status, geographic region and the use/non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline.
Quality of Life-Alzheimer's Disease (QoL-AD) Scale Score
The QoL-AD (Quality of Life - Alzheimer's Disease) scale assesses QoL in participants who have dementia. The QoL-AD consists of 13 items covering aspects of participants' relationships with friends and family, physical condition, mood, concerns about finances and overall assessment of QoL. Items are rated on 4-point Likert-type scales ranging from 1 [poor] to 4 [excellent]. The score range is from 13 to 52, with higher scores indicating a better QoL. The difference in mean change from Baseline to Week 77 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline.
Zarit Caregiver Interview for Alzheimer's Disease (ZCI-AD) Scale Score
The ZCI-AD is a modified version of the Zarit Burden Interview, which was originally designed to reflect the stresses experienced by caregivers of people with dementia. This modified version includes slight modifications in item and title wording (e.g., removal of "your relative" to refer directly to the patient, removal of "burden" from title) and the use of 11-point numerical rating scales. The ZCI-AD scale consists of a total of 30 items. Total scores will be calculated with a total score range from 0 to 300 (higher scores indicate a higher burden on the caregiver). The difference in mean change from Baseline to Week 53 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline.
European Quality of Life-5 Dimensions (EQ-5D) Questionnaire Domain Scores for Participants
The EQ-5D is a standardized measure of health status designed to provide a simple generic measure of health for clinical and economic appraisal. It is broadly applicable across a wide range of health conditions and treatment. The EQ-5D assesses five domains to provide a health state index. These are anxiety/depression, pain/discomfort, usual activities, mobility, and self-care. The scores on the EQ-5D ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). The difference in mean change from Baseline to Week 77 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline.
European Quality of Life-5 Dimensions (EQ-5D) Questionnaire Domain Scores for Caregivers
The EQ-5D is a standardized measure of health status designed to provide a simple generic measure of health for clinical and economic appraisal. It is broadly applicable across a wide range of health conditions and treatment. The EQ-5D assesses five domains to provide a health state index. These are anxiety/depression, pain/discomfort, usual activities, mobility, and self-care. The scores on the EQ-5D ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). The difference in mean change from Baseline to Week 77 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline.
Percentage of Participants With Adverse Event (AEs) and Serious Adverse Event (SAEs)
An Adverse Event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Percentage of Participants With Anti-Crenezumab Antibodies
Participants were considered positive or negative for ADA based on their baseline and post-baseline sample results. The number and percentage of participants with confirmed positive ADA levels were determined for Crenezumab and Placebo groups. The prevalence of ADA at baseline was calculated as the proportion of participants with confirmed positive ADA levels at baseline relative to the total number of participants with a sample available at baseline. The incidence of treatment-emergent ADAs was determined as the proportion of participants with confirmed post-baseline positive ADAs relative to the total number of participants that had at least one post-baseline sample available for ADA analysis.
Serum Concentration of Crenezumab
Serum concentration data for Crenezumab will be tabulated and summarized. Descriptive summary statistics will include the arithmetic mean and SD. Since a sparse PK sampling design is being used, population (non-linear mixed-effects) modeling will be used to analyze the dose concentration-time data of crenezumab. Information from other clinical studies may be incorporated to establish the PK model. Please note that Post-dose samples were not collected at Weeks 5, 13, 37, 53 and 77.
Plasma Amyloid Beta (Abeta) 40 Concentrations
Plasma Abeta 40 concentrations will be measured over time and descriptive summary statistics will include the arithmetic mean and SD. Please note that Pre-dose samples were only collected at Weeks 1 and 53.
Plasma Amyloid Beta (Abeta) 42 Concentrations
Plasma Abeta 42 concentrations will be measured over time and descriptive summary statistics will include the arithmetic mean and SD. Please note that Pre-dose samples were only collected at Weeks 1 and 53.
Percentage Change From Baseline to Week 105 in Whole Brain Volume as Determined by Magnetic Resonance Imaging (MRI)
Percentage Change in Whole Brain Volume will be measured over time and descriptive summary statistics will include the arithmetic mean, median, range, SD, and coefficient of variation, as appropriate. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline.
Percentage Change From Baseline to Week 105 in Ventricle Volume as Determined by Magnetic Resonance Imaging (MRI)
Percentage Change in Ventricle Volume will be measured over time and descriptive summary statistics will include the arithmetic mean, median, range, SD, and coefficient of variation, as appropriate. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline.
Percentage Change From Baseline to Week 105 in Hippocampal Volume as Determined by Magnetic Resonance Imaging (MRI)
Percentage Change in Hippocampal Volume will be measured over time and descriptive summary statistics will include the arithmetic mean, median, range, SD, and coefficient of variation, as appropriate. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03114657
Brief Title
A Study of Crenezumab Versus Placebo to Evaluate the Efficacy and Safety in Participants With Prodromal to Mild Alzheimer's Disease (AD)
Acronym
CREAD 2
Official Title
A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Study of Crenezumab in Patients With Prodromal to Mild Alzheimer's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Terminated
Why Stopped
This study was discontinued due to an interim analysis in the BN29552 study, which indicated that Crenezumab was unlikely to meet its primary endpoint.
Study Start Date
March 29, 2017 (Actual)
Primary Completion Date
June 11, 2019 (Actual)
Study Completion Date
June 11, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This randomized, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of crenezumab versus placebo in participants with prodromal to mild AD. Participants will be randomized 1:1 to receive either intravenous (IV) infusion of crenezumab or placebo every 4 weeks (Q4W) for 100 weeks. The primary efficacy assessment will be performed at 105 weeks. The participants who do not enter open-label extension will enter for a long term follow-up period for up to 52 weeks after the last crenezumab dose (Week 153).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
806 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received intravenous (IV) infusion of Placebo every 4 weeks (Q4W) for 100 weeks.
Arm Title
Crenezumab
Arm Type
Experimental
Arm Description
Participants received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W) for 100 weeks.
Intervention Type
Drug
Intervention Name(s)
Crenezumab
Intervention Description
Crenezumab was administered by intravenous (IV) infusion at 60mg/kg as per the dosing schedule described above.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo was administered by intravenous (IV) infusion at 60mg/kg as per the dosing schedule described above.
Primary Outcome Measure Information:
Title
Change From Baseline to Week 77 in Clinical Dementia Rating-Sum of Boxes (CDR-SB) Scale Score
Description
The CDR-SB rates impairment in 6 categories (memory, orientation, judgement and problem solving, community affairs, home and hobbies and personal care) on a 5-point scale in which no impairment = 0, questionable impairment = 0.5 and mild, moderate and severe impairment = 1, 2 and 3 respectively. The score range is from 0 to 18 with a high score indicating a high disease severity. The difference in mean change from Baseline to Week 77 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline for this primary endpoint. Data after 29 January 2019 are censored for the primary and secondary efficacy analyses to avoid potential biases due to investigators, participants, raters, etc. being potentially influenced by early closure of the study due to lack of efficacy.
Time Frame
Baseline, Week 77
Secondary Outcome Measure Information:
Title
Change From Baseline to Week 77 in Alzheimer's Disease Assessment Scale-Cognition 13 (ADAS-Cog-13) Subscale Score
Description
The ADAS-Cog-13 assesses multiple cognitive domains including memory, comprehension, praxis, orientation, and spontaneous speech. Most of these are assessed by tests although some are rated by the clinician on a 5-point scale. The ADAS-Cog-13 is the ADAS-Cog-11 with 2 further items: delayed word recall and total digit cancellation. The score range for ADAS-Cog-13 is from 0 to 85 with high scores representing severe dysfunction. The difference in mean change from Baseline to Week 77 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline.
Time Frame
Baseline, Week 77
Title
Change From Baseline to Week 77 in Alzheimer's Disease Assessment Scale-Cognition 11 (ADAS-Cog-11) Subscale Score
Description
The ADAS-Cog-11 assesses multiple cognitive domains including memory, comprehension, praxis, orientation, and spontaneous speech. Most of these are assessed by tests although some are rated by the clinician on a 5-point scale. The score range for ADAS-Cog-11 is from 0 to 70 with high scores representing severe dysfunction. The difference in mean change from Baseline to Week 77 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline.
Time Frame
Baseline, Week 77
Title
Change From Baseline to Week 77 on Severity of Dementia, Assessed Using the CDR-Global Score (CDR-GS)
Description
The CDR-GS represents a semi-structured interview which rates impairment in 6 categories (memory, orientation, judgement and problem solving, community affairs, home and hobbies, and personal care) on a 5-point scale in which CDR 0 = no dementia and CDR 0.5, 1, 2 or 3 = questionable, mild, moderate or severe dementia respectively. The range in scores for the CDR-GS is from 0 to 3 and a high score on the CDR-GS would indicate a high disease severity. The difference in mean change from Baseline to Week 77 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline.
Time Frame
Baseline, Week 77
Title
Change From Baseline to Week 77 on Severity of Dementia, Assessed Using the Mini Mental State Evaluation (MMSE)
Description
The MMSE is a set of standardized questions used to evaluate possible cognitive impairment and help stage the severity level of this impairment. The questions target 6 areas: orientation, registration, attention, short-term recall, language and constructional praxis/visuospatial abilities. The scores on the MMSE range from 0 to 30, with higher scores indicating better function. The difference in mean change from Baseline to Week 77 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline.
Time Frame
Baseline, Week 77
Title
Change From Baseline to Week 77 on Function as Assessed by (ADCS-ADL) Total Score
Description
The ADCS-ADL (Alzheimer's Disease Cooperative Study-Activities of Daily Living) is the scale most widely used to assess functional outcomes in participants with AD. The ADCS-ADL covers both basic ADL (e.g., eating and toileting) and more complex 'instrumental' ADL or iADL (e.g., using the telephone, managing finances and preparing a meal). The ADCS-ADL consists of 23 questions with a score range of 0 to 78 where a higher score represents better function. The difference in mean change from Baseline to Week 77 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline.
Time Frame
Baseline, Week 77
Title
Change From Baseline to Week 77 on Function as Assessed by (ADCS-iADL) Instrumental Score
Description
The ADCS-iADL (Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living) measures activities such as using the telephone, managing finances and preparing a meal. The ADCS-iADL consists of 16 questions with a score range of 0 to 56 where a higher score represents better function. The difference in mean change from Baseline to Week 77 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline.
Time Frame
Baseline, Week 77
Title
Change From Baseline to Week 77 on Function as Assessed by the Functional Activities Questionnaire (FAQ) Total Score
Description
The Functional Activities Questionnaire (FAQ) is an instrument consisting of 10 items and assesses instrumental, social and cognitive functioning. The score range is from 0 to 30 with higher scores representing higher impairment. The difference in mean change from Baseline to Week 77 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline.
Time Frame
Baseline, Week 77
Title
Change From Baseline to Week 77 on a Measure of Dependence Level Assessed From the ADCS-ADL Score
Description
The ADCS-ADL (Alzheimer's Disease Cooperative Study-Activities of Daily Living) is the scale most widely used to assess functional outcomes in participants with AD. The ADCS-ADL covers both basic ADL (e.g., eating and toileting) and more complex 'instrumental' ADL or iADL (e.g., using the telephone, managing finances and preparing a meal). The ADCS-ADL consists of 23 questions with a score range of 0 to 78 where a higher score represents better function. The difference in mean change from Baseline to Week 77 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline.
Time Frame
Baseline, Week 77
Title
Change From Baseline to Week 53 on Behavior in Neuropsychiatric Inventory Questionnaire (NPI-Q) Total Score
Description
The NPI-Q evaluates 12 neuropsychiatric disturbances common in dementia: delusions, hallucinations, agitation, dysphoria, anxiety, apathy, irritability, euphoria, disinhibition, aberrant motor behavior, night-time behavioral disturbances and appetite/eating abnormalities. The severity of each neuropsychiatric symptom is rated on a 3-point scale (mild, moderate and marked). The total severity score range is from 0 to 36 with higher scores representing higher severity. Difference in mean change from Baseline to Week 53 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures adjusting for disease severity, APOEe4 status, geographic region and the use/non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline.
Time Frame
Baseline, Week 53
Title
Quality of Life-Alzheimer's Disease (QoL-AD) Scale Score
Description
The QoL-AD (Quality of Life - Alzheimer's Disease) scale assesses QoL in participants who have dementia. The QoL-AD consists of 13 items covering aspects of participants' relationships with friends and family, physical condition, mood, concerns about finances and overall assessment of QoL. Items are rated on 4-point Likert-type scales ranging from 1 [poor] to 4 [excellent]. The score range is from 13 to 52, with higher scores indicating a better QoL. The difference in mean change from Baseline to Week 77 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline.
Time Frame
Baseline, Week 77
Title
Zarit Caregiver Interview for Alzheimer's Disease (ZCI-AD) Scale Score
Description
The ZCI-AD is a modified version of the Zarit Burden Interview, which was originally designed to reflect the stresses experienced by caregivers of people with dementia. This modified version includes slight modifications in item and title wording (e.g., removal of "your relative" to refer directly to the patient, removal of "burden" from title) and the use of 11-point numerical rating scales. The ZCI-AD scale consists of a total of 30 items. Total scores will be calculated with a total score range from 0 to 300 (higher scores indicate a higher burden on the caregiver). The difference in mean change from Baseline to Week 53 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline.
Time Frame
Baseline, Week 53
Title
European Quality of Life-5 Dimensions (EQ-5D) Questionnaire Domain Scores for Participants
Description
The EQ-5D is a standardized measure of health status designed to provide a simple generic measure of health for clinical and economic appraisal. It is broadly applicable across a wide range of health conditions and treatment. The EQ-5D assesses five domains to provide a health state index. These are anxiety/depression, pain/discomfort, usual activities, mobility, and self-care. The scores on the EQ-5D ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). The difference in mean change from Baseline to Week 77 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline.
Time Frame
Baseline, Week 77
Title
European Quality of Life-5 Dimensions (EQ-5D) Questionnaire Domain Scores for Caregivers
Description
The EQ-5D is a standardized measure of health status designed to provide a simple generic measure of health for clinical and economic appraisal. It is broadly applicable across a wide range of health conditions and treatment. The EQ-5D assesses five domains to provide a health state index. These are anxiety/depression, pain/discomfort, usual activities, mobility, and self-care. The scores on the EQ-5D ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). The difference in mean change from Baseline to Week 77 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline.
Time Frame
Baseline, Week 77
Title
Percentage of Participants With Adverse Event (AEs) and Serious Adverse Event (SAEs)
Description
An Adverse Event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Time Frame
Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
Title
Percentage of Participants With Anti-Crenezumab Antibodies
Description
Participants were considered positive or negative for ADA based on their baseline and post-baseline sample results. The number and percentage of participants with confirmed positive ADA levels were determined for Crenezumab and Placebo groups. The prevalence of ADA at baseline was calculated as the proportion of participants with confirmed positive ADA levels at baseline relative to the total number of participants with a sample available at baseline. The incidence of treatment-emergent ADAs was determined as the proportion of participants with confirmed post-baseline positive ADAs relative to the total number of participants that had at least one post-baseline sample available for ADA analysis.
Time Frame
Baseline up to Week 105
Title
Serum Concentration of Crenezumab
Description
Serum concentration data for Crenezumab will be tabulated and summarized. Descriptive summary statistics will include the arithmetic mean and SD. Since a sparse PK sampling design is being used, population (non-linear mixed-effects) modeling will be used to analyze the dose concentration-time data of crenezumab. Information from other clinical studies may be incorporated to establish the PK model. Please note that Post-dose samples were not collected at Weeks 5, 13, 37, 53 and 77.
Time Frame
Pre-infusion (0 hour), 60-90 minutes post-infusion on Day 1 Week 1 and on Week 25; Weeks 13 (Pre-dose), 37 (Pre-dose), 53 (Pre-dose) and 77 (Pre-dose) (infusion length = as per the Pharmacy Manual)
Title
Plasma Amyloid Beta (Abeta) 40 Concentrations
Description
Plasma Abeta 40 concentrations will be measured over time and descriptive summary statistics will include the arithmetic mean and SD. Please note that Pre-dose samples were only collected at Weeks 1 and 53.
Time Frame
Week 1 Day 1; Weeks 53
Title
Plasma Amyloid Beta (Abeta) 42 Concentrations
Description
Plasma Abeta 42 concentrations will be measured over time and descriptive summary statistics will include the arithmetic mean and SD. Please note that Pre-dose samples were only collected at Weeks 1 and 53.
Time Frame
Week 1 Day 1; Weeks 53
Title
Percentage Change From Baseline to Week 105 in Whole Brain Volume as Determined by Magnetic Resonance Imaging (MRI)
Description
Percentage Change in Whole Brain Volume will be measured over time and descriptive summary statistics will include the arithmetic mean, median, range, SD, and coefficient of variation, as appropriate. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline.
Time Frame
Baseline, Week 105
Title
Percentage Change From Baseline to Week 105 in Ventricle Volume as Determined by Magnetic Resonance Imaging (MRI)
Description
Percentage Change in Ventricle Volume will be measured over time and descriptive summary statistics will include the arithmetic mean, median, range, SD, and coefficient of variation, as appropriate. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline.
Time Frame
Baseline, Week 105
Title
Percentage Change From Baseline to Week 105 in Hippocampal Volume as Determined by Magnetic Resonance Imaging (MRI)
Description
Percentage Change in Hippocampal Volume will be measured over time and descriptive summary statistics will include the arithmetic mean, median, range, SD, and coefficient of variation, as appropriate. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline.
Time Frame
Baseline, Week 105
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Weight between 40 and 120 kilograms (Kg) inclusive
Availability of a person (referred to as the "caregiver") who in the investigator's judgment:
Has frequent and sufficient contact with the participant to be able to provide accurate information regarding the participant's cognitive and functional abilities, agrees to provide information at clinic visits (which require partner input for scale completion), signs the necessary consent form, and has sufficient cognitive capacity to accurately report upon the participant's behavior and cognitive and functional abilities
Fluency in the language of the tests used at the study site
Adequate visual and auditory acuity, in the investigator's judgment, sufficient to perform the neuropsychological testing (eye glasses and hearing aids are permitted)
Evidence of the AD pathological process, by a positive amyloid assessment either on cerebrospinal fluid (CSF) amyloid beta 1-42 levels as measured on the Elecsys beta-amyloid(1-42) test system or amyloid PET scan by qualitative read by the core/central PET laboratory
Demonstrated abnormal memory function at screening (up to 4 weeks before screening begins) or screening (FCSRT cueing index =<0.67 AND free recall =<27)
Screening mini mental state examination (MMSE) score of greater than or equal to (>=) 22 points and Clinical Dementia Rating-Global Score (CDR-GS) of 0.5 or 1.0
Meets National Institute on Aging/Alzheimer's Association (NIAAA) core clinical criteria for probable AD dementia or prodromal AD (consistent with the NIAAA diagnostic criteria and guidelines for mild cognitive impairment (MCI)
If receiving symptomatic AD medications, the dosing regimen must have been stable for 3 months prior to screening
Participant must have completed at least 6 years of formal education after the age of 5 years
Exclusion Criteria:
Any evidence of a condition other than AD that may affect cognition such as other dementias, stroke, brain damage, autoimmune disorders (e.g. multiple sclerosis) or infections with neurological sequelae.
History of major psychiatric illness such as schizophrenia or major depression (if not considered in remission)
At risk of suicide in the opinion of the investigator
Any abnormal MRI findings, such as presence of cerebral vascular pathology, cortical stroke, etc or inability to tolerate MRI procedures or contraindication to MRI
Unstable or clinically significant cardiovascular (e.g., myocardial infarction), kidney or liver disease
Uncontrolled hypertension
Screening hemoglobin A1c (HbA1C) >8%
Poor peripheral venous access
History of cancer except:
If considered to be cured or If not being actively treated with anti-cancer therapy or radiotherapy
- Known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Imaging End Points Clinical Research
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
Health Initiatives Research, PLLC
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72703
Country
United States
Facility Name
Clinical Trials Inc.
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Neuro-Therapeutics Inc.
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Desert Valley Medical Group
City
Rancho Mirage
State/Province
California
ZIP/Postal Code
92270
Country
United States
Facility Name
Anderson Clinical Research, Inc.
City
Redlands
State/Province
California
ZIP/Postal Code
92374
Country
United States
Facility Name
University of California, Davis; Alzheimers Disease Center, Department of Neurology
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
UCSF - Memory and Aging Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
MCB Clinical Research Centers
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80910
Country
United States
Facility Name
Research Center for Clinical Studies, Inc.
City
Norwalk
State/Province
Connecticut
ZIP/Postal Code
06851
Country
United States
Facility Name
KI Health Partners, LLC; New England Institute for Clinical Research
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06905
Country
United States
Facility Name
Georgetown University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20057
Country
United States
Facility Name
JEM Research LLC
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Facility Name
Bradenton Research Center
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34205
Country
United States
Facility Name
Neuropsychiatric Research; Center of Southwest Florida
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
Alzheimer's Research and Treatment Center
City
Lake Worth
State/Province
Florida
ZIP/Postal Code
33414
Country
United States
Facility Name
Renstar Medical Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
34470
Country
United States
Facility Name
Bioclinica Research
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Progressive Medical Research
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Facility Name
Columbus Memory Center
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31909
Country
United States
Facility Name
Lake Charles Clinical Trials, LLC
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70601
Country
United States
Facility Name
Alzheimers Disease Center; Neurology
City
Winchester
State/Province
Massachusetts
ZIP/Postal Code
01890
Country
United States
Facility Name
Health Partners Institute for Education and Research
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55130
Country
United States
Facility Name
Precise Research Centers
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Facility Name
University of Nebraska Medical Center; Dept of Neurological Sciences
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-8440
Country
United States
Facility Name
Cleveland Clinic Lou Ruvo; Center for Brain Research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
The Cognitive and Research Center of New Jersey
City
Summit
State/Province
New Jersey
ZIP/Postal Code
07081
Country
United States
Facility Name
Advanced Memory Research Institute of NJ
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Burke Rehabilitation Hospital
City
White Plains
State/Province
New York
ZIP/Postal Code
10605
Country
United States
Facility Name
Behavioral Health Research
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28211
Country
United States
Facility Name
Wake Research Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
University of Cincinnati; Department of Psychiatry and Behavioral Neuroscience
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Ohio State University; College of Medicine
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Dayton Center for Neuro Disorders
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45459
Country
United States
Facility Name
Summit Research Network Inc.
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Northeastern Pennsylvania Memory
City
Plains
State/Province
Pennsylvania
ZIP/Postal Code
18705
Country
United States
Facility Name
Abington Neurological Associates
City
Willow Grove
State/Province
Pennsylvania
ZIP/Postal Code
19090
Country
United States
Facility Name
Neurology Clinic PC
City
Cordova
State/Province
Tennessee
ZIP/Postal Code
38018
Country
United States
Facility Name
Senior Adults Specialty Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78757
Country
United States
Facility Name
Gadolin Research, LLC
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77702
Country
United States
Facility Name
Texas Neurology PA
City
Dallas
State/Province
Texas
ZIP/Postal Code
75214
Country
United States
Facility Name
Kerwin Research Center, LLC
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Alzheimers Disease & Memory Disorders Center; Department of Neurology Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Clinical Trials of Texas, Inc
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Sentara Medical Group
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
National Clinical Research Inc.-Richmond
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
Facility Name
Hospital Italiano
City
Buenos Aires
ZIP/Postal Code
C1181ACH
Country
Argentina
Facility Name
Universidad Maimonides
City
Caba
ZIP/Postal Code
C1405BCK
Country
Argentina
Facility Name
DAMIC
City
Cordoba
ZIP/Postal Code
X500 3DCE
Country
Argentina
Facility Name
St Vincent's Hospital Sydney
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Central Coast Neurosciences Research
City
Erina
State/Province
New South Wales
ZIP/Postal Code
2250
Country
Australia
Facility Name
Hornsby Ku-ring-gai Hospital; Division of Rehabilitation & Aged Care
City
Hornsby
State/Province
New South Wales
ZIP/Postal Code
2077
Country
Australia
Facility Name
The Queen Elizabeth Hospital; Neurology
City
Woodville
State/Province
South Australia
ZIP/Postal Code
5011
Country
Australia
Facility Name
AZ Sint Jan
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
AZ Groeninge
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
Facility Name
UZ Leuven Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
CCBR - Brasilia
City
Brasilia
State/Province
DF
ZIP/Postal Code
70200-730
Country
Brazil
Facility Name
Hospital das Clinicas - UFMG
City
Belo Horizonte
State/Province
MG
ZIP/Postal Code
31270-901
Country
Brazil
Facility Name
Instituto de Neurologia de Curitiba
City
Curitiba
State/Province
PR
ZIP/Postal Code
81210-310
Country
Brazil
Facility Name
Centro Psiquiatria Sandra Ruschel Ltda
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
22270-060
Country
Brazil
Facility Name
Hospital das Clinicas - UFRGS
City
Porto Alegre
State/Province
RS
Country
Brazil
Facility Name
Clínica Dr. Norton Sayeg LTDA - EPP
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04534-011
Country
Brazil
Facility Name
OCT Research ULC
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 1Z9
Country
Canada
Facility Name
Vancouver Island Health Authority
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 1J8
Country
Canada
Facility Name
True North Clinical Research-Halifax
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3S 1M7
Country
Canada
Facility Name
True North Clinical Research Kentville
City
Kentville
State/Province
Nova Scotia
ZIP/Postal Code
B4N 5E3
Country
Canada
Facility Name
Providence Care; Mental Health Services
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 4X3
Country
Canada
Facility Name
Parkwood Hospital; Geriatric Medicine
City
London
State/Province
Ontario
ZIP/Postal Code
N6C 5J1
Country
Canada
Facility Name
Kawartha Centre - Redefining Healthy Aging
City
Peterborough
State/Province
Ontario
ZIP/Postal Code
K9H 2P4
Country
Canada
Facility Name
The Centre for Memory and Aging
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4G 3E8
Country
Canada
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1N9
Country
Canada
Facility Name
Devonshire Clinical Research Inc.
City
Woodstock
State/Province
Ontario
ZIP/Postal Code
N4S 5P5
Country
Canada
Facility Name
Clinique Neuro Rive-Sud
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2J2
Country
Canada
Facility Name
ALPHA Recherche Clinique
City
Quebec
ZIP/Postal Code
G3K 2P8
Country
Canada
Facility Name
Beijing Union Hospital
City
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Tianjin Medical University General Hospital
City
Tianjin (天津)
ZIP/Postal Code
300052
Country
China
Facility Name
Aarhus Universitetshospital, Neurologisk Afdeling F, Demensklinikken
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Rigshospitalet, Hukommelsesklinikken
City
København Ø
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Laane-Tallinna Keskhaigla
City
Tallinn
ZIP/Postal Code
10617
Country
Estonia
Facility Name
Hopital Pellegrin; Cmrr Aquitaine
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Hôpital de Jour du Centre pour Personnes Âgées; Louis Pasteur Neurologie
City
Colmar
ZIP/Postal Code
68000
Country
France
Facility Name
Hopital Roger Salengro; Service de Neurologie
City
Lille
Country
France
Facility Name
CHU de Limoges Hopital Dupuytren; Service de Medecine Geriatrique
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
Hopital Broca
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
CH Pitie Salpetriere; IM2A
City
Paris
ZIP/Postal Code
75651
Country
France
Facility Name
Hôpital Maison Blanche
City
Reims
ZIP/Postal Code
51092
Country
France
Facility Name
CHU Rennes - Hopital Pontchaillou
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
CHU de Rouen Hopital; Service de Neurologie
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
Hop Guillaume Et Rene Laennec; Cmrr St Herblain
City
St Herblain
ZIP/Postal Code
44800
Country
France
Facility Name
Hopital des Charpennes
City
Villeurbanne
ZIP/Postal Code
69100
Country
France
Facility Name
ECRC Experimental and Clinical Research Center, Charité Campus Berlin Buch, Memory Clinic
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
Klinikum Joh.Wolfg.Goethe-UNI Zentrum d. Psychiatrie Klinik f. Psychiatrie Psychosomatik
City
Frankfurt
ZIP/Postal Code
60528
Country
Germany
Facility Name
Universitätsklinikum Freiburg, Zentrum für Geriatrie und Gerontologie
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Universitätsklinikum des Saarlandes Klinik f. Psychiatrie und Psychotherapie
City
Homburg/Saar
ZIP/Postal Code
66421
Country
Germany
Facility Name
PANAKEIA - Arzneimittelforschung Leipzig GmbH
City
Leipzig
ZIP/Postal Code
04275
Country
Germany
Facility Name
Pharmakologisches Studienzentrum
City
Mittweida
ZIP/Postal Code
09648
Country
Germany
Facility Name
Klinikum rechts der Isar der TU München; Klinik für Psychiatrie und Psychotherapie
City
München
ZIP/Postal Code
81675
Country
Germany
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Sheba Medical Center; Psychiatry Department
City
Ramat Gan
ZIP/Postal Code
5262100
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center; Department of Neurology
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Azienda Ospedaliera Universitaria Policlinico Tor Vergata; Neurologia
City
Roma
State/Province
Lazio
ZIP/Postal Code
00133
Country
Italy
Facility Name
Umberto I Policlinico di Roma-Università di Roma La Sapienza
City
Roma
State/Province
Lazio
ZIP/Postal Code
00185
Country
Italy
Facility Name
Ospedale San Giovanni Calibita Fatebenefratell;Neurologia
City
Roma
State/Province
Lazio
ZIP/Postal Code
00186
Country
Italy
Facility Name
IRCCS "Centro S. Giovanni di Dio" Fatebenefratelli -UO Alzheimer
City
Brescia
State/Province
Lombardia
ZIP/Postal Code
25125
Country
Italy
Facility Name
Irccs Multimedica Santa Maria; Unita' Di Neurologia
City
Castellanza
State/Province
Lombardia
ZIP/Postal Code
21053
Country
Italy
Facility Name
IRCCS Ospedale San Raffaele; Centro Disturbi della Memoria
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20132
Country
Italy
Facility Name
Fondazione IRCCS Istituto Nazionale Neurologico Besta; UO Neuropatologia
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20133
Country
Italy
Facility Name
Ospedale S. Maria Nascente; Fondazione Don Gnocchi; Dip. Neurologia Riabilitativa
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20148
Country
Italy
Facility Name
Ospedale Casati Passirana di Rho; Centro Regionale Alzheimer
City
Passirana
State/Province
Lombardia
ZIP/Postal Code
20017
Country
Italy
Facility Name
IRCCS Neuromed; Neurologia I-Centro studio e cura delle demenze e UVA
City
Pozzilli
State/Province
Molise
ZIP/Postal Code
86077
Country
Italy
Facility Name
AO Città della Salute e della Scienza Osp.S.Giov.Battista Molinette; SC Geriatria
City
Torino
State/Province
Piemonte
ZIP/Postal Code
10126
Country
Italy
Facility Name
A.O. Universitaria Pisana; Neurologia
City
Pisa
State/Province
Toscana
ZIP/Postal Code
56126
Country
Italy
Facility Name
National Center for Geriatrics and Gerontology
City
Aichi
ZIP/Postal Code
474-8511
Country
Japan
Facility Name
Inage Neurology and Memory Clinic
City
Chiba
ZIP/Postal Code
263-0043
Country
Japan
Facility Name
Fukuoka Mirai Hospital
City
Fukuoka
ZIP/Postal Code
813-0017
Country
Japan
Facility Name
National Hospital Organization Hiroshima-Nishi Medical Center
City
Hiroshima
ZIP/Postal Code
739-0696
Country
Japan
Facility Name
Tsukazaki Hospital
City
Hyogo
ZIP/Postal Code
671-1227
Country
Japan
Facility Name
Iwate Medical University Hospital
City
Iwate
ZIP/Postal Code
028-3695
Country
Japan
Facility Name
Kagawa Prefectural Central Hospital
City
Kagawa
ZIP/Postal Code
760-8557
Country
Japan
Facility Name
Fujisawa City Hospital
City
Kanagawa
ZIP/Postal Code
251-8550
Country
Japan
Facility Name
National Hospital Organization Sagamihara National Hospital
City
Kanagawa
ZIP/Postal Code
252-0392
Country
Japan
Facility Name
Ijinkai Takeda General Hospital
City
Kyoto
ZIP/Postal Code
601-1495
Country
Japan
Facility Name
Rakuwakai Otowarehabilitation Hospital
City
Kyoto
ZIP/Postal Code
607-8113
Country
Japan
Facility Name
National Hospital Organization Matsumoto Medical Center
City
Nagano
ZIP/Postal Code
399-8701
Country
Japan
Facility Name
Katayama Medical Clinic
City
Okayama
ZIP/Postal Code
710-0813
Country
Japan
Facility Name
Osaka University Hospital
City
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
Asakayama General Hospital
City
Osaka
ZIP/Postal Code
590-0018
Country
Japan
Facility Name
NHO Shizuoka Institute of Epilepsy and Neurological Disorders
City
Shizuoka
ZIP/Postal Code
420-8688
Country
Japan
Facility Name
Kanto Central Hospital
City
Tokyo
ZIP/Postal Code
158-8531
Country
Japan
Facility Name
Tokyo Medical University Hospital
City
Tokyo
ZIP/Postal Code
160-0023
Country
Japan
Facility Name
Shinjuku Research Park Clinic
City
Tokyo
ZIP/Postal Code
169-0073
Country
Japan
Facility Name
Tokyo Metropolitan Geriatric Hospital
City
Tokyo
ZIP/Postal Code
173-0015
Country
Japan
Facility Name
National Center of Neurology and Psychiatry
City
Tokyo
ZIP/Postal Code
187-8551
Country
Japan
Facility Name
Tokyo Medical University Hachioji Medical Center
City
Tokyo
ZIP/Postal Code
193-0998
Country
Japan
Facility Name
Dong-A University Hospital
City
Busan
ZIP/Postal Code
49201
Country
Korea, Republic of
Facility Name
Gachon University Gil Medical Center
City
Incheon
ZIP/Postal Code
21565
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
ZIP/Postal Code
13605
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Hanyang University Seoul Hospital
City
Seoul
ZIP/Postal Code
04763
Country
Korea, Republic of
Facility Name
Konkuk University Medical Center
City
Seoul
ZIP/Postal Code
05030
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Seoul St Mary's Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Borame Medical Center
City
Seoul
ZIP/Postal Code
07061
Country
Korea, Republic of
Facility Name
Akershus universitetssykehus HF; Nevroklinikken S203
City
Lørenskog
ZIP/Postal Code
1478
Country
Norway
Facility Name
Oslo universitetssykehus HF Ullevål sykehus; Hukommelsesklinikken
City
Oslo
ZIP/Postal Code
0450
Country
Norway
Facility Name
Clinica Internacional; Unidad De Investigacion
City
Lima
ZIP/Postal Code
15001
Country
Peru
Facility Name
Hospital Nacional Dos de Mayo; Unidad de Investigacion de Neurologia
City
Lima
ZIP/Postal Code
Lima 01
Country
Peru
Facility Name
NZOZ Dom Sue Ryder
City
Bydgoszcz
ZIP/Postal Code
85-023
Country
Poland
Facility Name
Centrum Medyczne Euromedis Sp. z o.o.
City
Szczecin
ZIP/Postal Code
70-111
Country
Poland
Facility Name
Centrum Medyczne NeuroProtect
City
Warszawa
ZIP/Postal Code
01-684
Country
Poland
Facility Name
NZOZ WCA
City
Wrocław
ZIP/Postal Code
53-659
Country
Poland
Facility Name
Hospital de Braga; Servico de Neurologia
City
Braga
ZIP/Postal Code
4710-243
Country
Portugal
Facility Name
HUC; Servico de Neurologia
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Facility Name
Hospital Pedro Hispano; Servico de Neurologia
City
Matosinhos
ZIP/Postal Code
4464-513
Country
Portugal
Facility Name
Hospital Geral de Santo Antonio; Servico de Neurologia
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Facility Name
LLC Baltic Medicine
City
Saint-Petersburg
State/Province
Sankt Petersburg
ZIP/Postal Code
194356
Country
Russian Federation
Facility Name
State Healthcare Institution of Sverdlovsk Region Sverdlovsk Regional Clinical Psychiatric Hospita
City
Ekaterinburg
State/Province
Sverdlovsk
ZIP/Postal Code
620030
Country
Russian Federation
Facility Name
State Autonomous Healthcare Institution "Republican Clinical Neurological Center
City
Kazan
ZIP/Postal Code
420021
Country
Russian Federation
Facility Name
State autonomous institution of healthcare Inter-regional clinical and diagnostic center
City
Kazan
ZIP/Postal Code
420101
Country
Russian Federation
Facility Name
Institution of RAMS (Mental Health Research Center of RAMS)
City
Moscow
ZIP/Postal Code
115522
Country
Russian Federation
Facility Name
City Clinical Psychiatry Hospital #1
City
Nizhny Novgorod
ZIP/Postal Code
603155
Country
Russian Federation
Facility Name
St Nicolas Psychiatric Hospital; Chair of Psychiatry and Narcology of St. Petersburg Medical Academy
City
St Petersburg
ZIP/Postal Code
190121
Country
Russian Federation
Facility Name
Nebbiolo Center for Clinical Trials
City
Tomsk
ZIP/Postal Code
634009
Country
Russian Federation
Facility Name
Clinic for Mental disorders Dr Laza Lazarevic
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Neurology clinic, Clinical Center of Serbia
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinic for neurology, Clinical Center Kragujevac
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Facility Name
Private Practice; the Osteoporosis Clinic
City
Johannesburg
ZIP/Postal Code
2196
Country
South Africa
Facility Name
Hospital General Universitario de Elche; Servicio de Neurología
City
Elche
State/Province
Alicante
ZIP/Postal Code
03203
Country
Spain
Facility Name
Fundació ACE
City
BArcelon
State/Province
Barcelona
ZIP/Postal Code
08034
Country
Spain
Facility Name
Hospital General De Catalunya; Servicio de Neurologia
City
Sant Cugat del Valles
State/Province
Barcelona
ZIP/Postal Code
8195
Country
Spain
Facility Name
Hospital Mutua De Terrasa; Servicio de Neurologia
City
Terrassa
State/Province
Barcelona
ZIP/Postal Code
08222
Country
Spain
Facility Name
Hospital Virgen del Puerto. Servicio de Neurología
City
Plasencia
State/Province
Caceres
ZIP/Postal Code
10600
Country
Spain
Facility Name
Hospital Universitario Marques de Valdecilla; Servicio de Neurología
City
Santander
State/Province
Cantabria
Country
Spain
Facility Name
Hospital Santa Caterina, Unitat de Valoració de la memoria i les demencies
City
Salt
State/Province
Girona
ZIP/Postal Code
17090
Country
Spain
Facility Name
Policlínica Guipuzkoa; Servicio de Neurología
City
Donosti-San Sebastián
State/Province
Guipuzcoa
ZIP/Postal Code
20014
Country
Spain
Facility Name
Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Neurologia
City
Santiago de Compostela
State/Province
LA Coruña
ZIP/Postal Code
15706
Country
Spain
Facility Name
Hospital San Pedro; Servicio de Neurología
City
Logroño
State/Province
LA Rioja
ZIP/Postal Code
26006
Country
Spain
Facility Name
Hospital Quiron de Madrid; Servicio de Neurologia
City
Pozuelo de Alarcon
State/Province
Madrid
ZIP/Postal Code
28223
Country
Spain
Facility Name
Clinica Universitaria de Navarra; Servicio de Neurología
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
CAE Oroitu
City
BaraKaldo
State/Province
Vizcaya
ZIP/Postal Code
48903
Country
Spain
Facility Name
Hospital Perpetuo Socorro, Servicio de Geriatria
City
Albacete
ZIP/Postal Code
2006
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau; Servicio de Neurologia
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital Universitario de Burgos. Servicio de Neurología
City
Burgos
ZIP/Postal Code
09006
Country
Spain
Facility Name
Hospital la Magdalena; Servicio de Neurologia
City
Castellon
ZIP/Postal Code
12004
Country
Spain
Facility Name
Hospital Universitario Reina Sofia; Servicio de Neurologia
City
Cordoba
ZIP/Postal Code
14011
Country
Spain
Facility Name
Hospital Ramon y Cajal; Servicio de Neurologia
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Complejo Asistencial Universitario de Salamanca; Servicio de Psiquiatría; CSM La Alamedilla
City
Salamanca
ZIP/Postal Code
37005
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena; Servicio de Neurologia
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Skånes Universitetssjukhus Malmö, Minneskliniken
City
Malmö
ZIP/Postal Code
211 46
Country
Sweden
Facility Name
Sahlgrenska Academy University,Neuroscience and Physiology;Departmt of Psychiatry and Neurochemistry
City
Mölndal
ZIP/Postal Code
431 41
Country
Sweden
Facility Name
Changhua Christian Hospital; Neurology
City
Changhua County
ZIP/Postal Code
500
Country
Taiwan
Facility Name
Kaohsiung Medical University Hospital; Neurology
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Facility Name
Taipei Medical University - Shuang Ho Hospital - Neurology
City
New Taipei City
ZIP/Postal Code
23561
Country
Taiwan
Facility Name
National Taiwan University Hospital; Neurology
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Chang Gung Memorial Foundation - Linkou - Neurology
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Hacettepe University Medical Faculty; Neurology
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Istanbul University Istanbul School of Medicine; Neurology
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
Facility Name
Ondokuz Mayis Univ. Med. Fac.; Neurology
City
Samsun
ZIP/Postal Code
55139
Country
Turkey
Facility Name
The Fritchie Centre, Charlton Lane Centre, Charlon Lane, Leckhampton; The Fritchie Centre
City
Cheltenham
ZIP/Postal Code
GL53 9DZ
Country
United Kingdom
Facility Name
Surrey and Borders NHS Foundation Trust; Brain Science Research Unit
City
Chertsey
ZIP/Postal Code
KT16 0AE
Country
United Kingdom
Facility Name
Sussex Partnership NHS Foundation Trust; Cognitive Treatment and Research unit
City
Crowborough
ZIP/Postal Code
TN6 1HB
Country
United Kingdom
Facility Name
Ninewells Hospital
City
Dundee
ZIP/Postal Code
DD12 9SY
Country
United Kingdom
Facility Name
NHS Lothian - Western General Hospital; NHS Lothian - Western General Hospital
City
Edinburgh
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
Queen Elizabeth University Hospital; Clinical Research Facility
City
Glasgow
ZIP/Postal Code
G51 4TF
Country
United Kingdom
Facility Name
RE:Cognition Health
City
London
ZIP/Postal Code
W1G 9RU
Country
United Kingdom
Facility Name
Charing Cross Hospital; Imperial Memory Unit, Level 10 West
City
London
ZIP/Postal Code
W6 8RF
Country
United Kingdom
Facility Name
Manchester Royal Infirmary
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom
Facility Name
John Radcliffe Hospital
City
Oxford
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
Facility Name
University Southampton NHS Foundation Trust; Wessex Neurologica Centre
City
Southampton
ZIP/Postal Code
SO166YD
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
36121669
Citation
Ostrowitzki S, Bittner T, Sink KM, Mackey H, Rabe C, Honig LS, Cassetta E, Woodward M, Boada M, van Dyck CH, Grimmer T, Selkoe DJ, Schneider A, Blondeau K, Hu N, Quartino A, Clayton D, Dolton M, Dang Y, Ostaszewski B, Sanabria-Bohorquez SM, Rabbia M, Toth B, Eichenlaub U, Smith J, Honigberg LA, Doody RS. Evaluating the Safety and Efficacy of Crenezumab vs Placebo in Adults With Early Alzheimer Disease: Two Phase 3 Randomized Placebo-Controlled Trials. JAMA Neurol. 2022 Nov 1;79(11):1113-1121. doi: 10.1001/jamaneurol.2022.2909.
Results Reference
derived
Learn more about this trial
A Study of Crenezumab Versus Placebo to Evaluate the Efficacy and Safety in Participants With Prodromal to Mild Alzheimer's Disease (AD)
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