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A Study Evaluating the Efficacy and Safety of Crenezumab Versus Placebo in Participants With Prodromal to Mild Alzheimer's Disease (AD). (CREAD)

Primary Purpose

Alzheimer's Disease

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Crenezumab
Placebo
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

  • Banner Alzheimer's Institute
  • Pharmacology Research Inst
  • Collaborative Neuroscience Network Inc.
  • Alliance for Wellness, dba Alliance for Research
  • Pharmacology Research Institute
  • USC Keck School Of Medicine
  • UCLA Medical Center, Department of Neurology
  • Pharmacology Research Inst
  • Shankle Clinic
  • Stanford Univ Medical Center
  • Anderson Clinical Research, Inc.
  • University of California, Davis; Alzheimers Disease Center, Department of Neurology
  • UCSF - Memory and Aging Center
  • Neurological Research Inst
  • North Bay Neuro Science Institute
  • Associated Neurologists PC - Danbury
  • Institute for Neurodegenerative Disorders
  • Yale University School Of Medicine
  • Research Center for Clinical Studies, Inc.
  • Bradenton Research Center
  • Quantum Laboratories
  • Brain Matters Research, Inc.
  • Galiz Research, LLC
  • Jacksonville Center For Clinical Research
  • Alzheimer's Research and Treatment Center
  • Merritt - Island Medical Research
  • Miami Jewish Health Systems
  • Renstar Medical Research
  • Bioclinica Research
  • Progressive Medical Research
  • Johnnie B. Byrd Sr. Alzheimer's Center & Research Institute
  • Stedman Clinical Trials, LLC
  • Compass Research
  • Emory University
  • NeuroStudies.net, LLC
  • Alexian Brothers Neurosci Inst
  • Southern Illinois University, School of Medicine
  • Indiana University
  • MidAmerica Neuroscience Institute
  • Maine Research Associates
  • MMP Neurology
  • Springfield Neurology Associates
  • Precise Research Centers
  • The Cognitive and Research Center of New Jersey
  • Advanced Memory Research Institute of NJ
  • Albany Medical Faculty Physicians COmmunity Division. The Neurology Group
  • Neurological Associates of Albany, PC
  • Dent Neurological Institute
  • Columbia University Medical Center
  • South Shore Neurologic Associates P.C.
  • Behavioral Health Research
  • Guilford Neurologic Associates
  • Valley Medical Primary Care
  • Insight Clinical Trials LLC
  • Oklahoma Clinical Research
  • Cutting Edge Research Group
  • Central States Research
  • Summit Research Network Inc.
  • Drexel Univ College of Med; Clinical Research Group
  • Abington Neurological Associates
  • Senior Adults Specialty Research
  • Kerwin Research Center, LLC
  • University of North Texas Health Science Center; Fort Worth Patient Care Center
  • Sentara Medical Group
  • National Clinical Research Inc.-Richmond
  • Medical College of Wisconsin
  • The Queen Elizabeth Hospital; Neurology
  • Caulfield Hospital; Aged Psychiatry Research Unit
  • Heidelberg Repatriation Hospital; Medical and Cognitive Research Centre
  • Neurodegenerative Disorders Research; Neurology
  • Konventhospital Barmherzige Brüder; Neurologie I
  • UZ Gent
  • ACIBADEM CITY CLINIC TOKUDA HOSPITAL EAD; Clinic of Neurology and Sleep Medicine
  • Alexandrovska hospital; Neurology Department
  • Vancouver Hospital - UBC Hospital Site
  • Vancouver Island Health Authority
  • Parkwood Hospital; Geriatric Medicine
  • Bruyere Continuing Care
  • Kawartha Centre - Redefining Healthy Aging
  • The Centre for Memory and Aging
  • Toronto Western Hospital
  • Devonshire Clinical Research Inc.
  • CHA Hopital de I enfant-Jesus
  • ICIMED Instituto de Investigación en Ciencias Médicas
  • Hospital Clínica Biblica
  • Clinical Hospital Centre Zagreb;Clinic for Neurology
  • Charles University, Medical faculty, Hradec Kralove ;Department of Neurology
  • General Teaching Hospital, Departmetn of Neurology
  • Aarhus Universitetshospital, Neurologisk Afdeling F, Demensklinikken
  • Rigshospitalet, Hukommelsesklinikken
  • Terveystalo Tampere
  • CRST Oy
  • Hopital Avicenne; Neurologie
  • Hopital neurologique Pierre Wertheimer - CHU Lyon; Neurologie
  • Hopital Gui de Chauliac; Neurologie
  • Hopital Lariboisiere
  • CHU Poitiers - Hopital La Miletrie
  • Hopital Hautepierre; Centre dInvestigation Clinique
  • CHU Toulouse - La Grave
  • Neurologische Praxis Dr. Andrej Pauls
  • Klinikum rechts der Isar der TU München; Klinik für Psychiatrie und Psychotherapie
  • Universitätsklinikum Münster; Klinik und Poliklinik für Neurologie
  • Steinwachs Klaus; Arztpraxis fur Neurologie u. Psychiatrie
  • Universitätsklinikum Rostock Zentrum für Nervenheilkunde
  • Universitätsklinikum Ulm; Klinik für Neurologie
  • Studienzentrum Nordwest, Dr. med. Joachim Springub / Herr Wolfgang Schwarz
  • Forschungszentrum Ruhr
  • Prince of Wales Hospital; Dept. of Medicine & Therapeutics
  • Queen Mary Hospital, Division of Geriatric Medicine
  • Semmelweis University; Department of Neurology
  • Szabolcs-Szatmár-Bereg Megyei Kórházak - Jósa András Oktatókórház; Pszichiátria
  • University of Szeged; Department of Psychiatry
  • Szent Borbala Korhaz; Neurologiai es Stroke Osztaly
  • Jávorszky Ödön Kórház, Neurológia és stroke osztály
  • Fondazione Santa Lucia IRCCS; Neurologia e Riabilitazione Neurologica
  • Ospedale San Giovanni Calibita Fatebenefratell;Neurologia
  • Ente Ospedaliero Ospedali Galliera; Ambulatorio di Neurologia
  • Casa di Cura Policlinico; Dipartimento di Scienze Neuroriabilitative
  • Ospedale S. Maria Nascente; Fondazione Don Gnocchi; Dip. Neurologia Riabilitativa
  • Ospedale Casati Passirana di Rho; Centro Regionale Alzheimer
  • Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; S.C. Geriatria
  • Miyoshi Clinic of Neurology, Hananosato
  • National Hospital Organization Hiroshima-Nishi Medical Center
  • Rakuwakai Otowarehabilitation Hospital
  • Mie University Hospital
  • National Hospital Organization Matsumoto Medical Center
  • Saigata Medical Center
  • Katayama Medical Clinic
  • Tokyo Medical University Hospital
  • Tokyo Metropolitan Geriatric Hospital
  • National Center of Neurology and Psychiatry
  • Chonnam National University Hospital
  • Inha University Hospital
  • Konkuk University Medical Center
  • Asan Medical Center
  • KyungHee Medical Center
  • Ewha Womans University Mokdong Hospital; Dept of Neurology
  • Vilnius University Hospital Santariskiu Clinic
  • Hospital Angeles de Culiacán, Neurociencias Estudios Clínicos SC
  • Hospital Uni; Dr. Jose E. Gonzalez
  • AVIX Investigación Clínica S.C
  • Hospital Universitario de Saltillo
  • Podlaskie Centrum Psychogeriatrii
  • NZOZ NEURO-KARD Ilkowski i Partnerzy Sp. Partn. Lek
  • NEURO-CARE Sp. z o.o. Sp. Komandytowa
  • Przychodnia Specjalistyczna PROSEN
  • Centrum Medyczne NeuroProtect
  • Optimum
  • Hospital Prof. Dr. Fernando Fonseca; Servico de Neurologia
  • Hospital Beatriz Angelo; Servico de Neurologia
  • 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)
  • SBEI of HPI The 1st Moscow State Medical University n.a. I.M. Sechenov of MOH of RF
  • City Clinical Hospital # 2 n.a. V.I. Razumovsky
  • SHI City Psychoneurological Dispensary #7
  • Russian Medical Military Academy n.a. S.M.Kirov; Neurology Department
  • University Medical Centre Maribor
  • Fundació ACE
  • Hospital Universitari de Bellvitge; Servicio de Neurologia
  • Hospital Sant Joan de Deu; Servicio de Neurología
  • 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
  • Clinica Universitaria de Navarra; Servicio de Neurología
  • Complejo Asistencial Universitario de Salamanca; Servicio de Psiquiatría
  • Hospital General Universitario de Albacete; Servicio de Neurología
  • Hospital Vall d'Hebron; Servicio de Neurología
  • Hospital Universitario de Burgos. Servicio de Neurología
  • Clinica Ruber, 4 planta; Servicio de Neurologia
  • Universitario de La Princesa; Servicio de Neurología
  • Hospital Universitario 12 de Octubre; Servicio de Neurologia
  • Hospital Regional Universitario Carlos Haya; Servicio de Neurologia
  • Hospital Universitario Virgen de Arrixaca; Servicio de Neurología
  • Hospital Universitario la Fe; Servicio de Neurologia
  • Servicio de Neurología Hospital Viamed Montecanal.
  • Skånes Universitetssjukhus Malmö, Minneskliniken
  • Sahlgrenska Academy University,Neuroscience and Physiology;Departmt of Psychiatry and Neurochemistry
  • Karolinska Uni Hospital, Huddinge; Dept. of Geriatric Med
  • Universitäres Zentrum für Altersmedizin und Rehabilitation
  • Hacettepe University School of Medicine; Neurology
  • Osmangazi University School of Medicine,Neurology Department
  • Istanbul University Istanbul School of Medicine; Neurology
  • Ondokuz Mayis University School of Medicine; Neurology
  • Regional mental hospital; Department of psychiatry, psychology and sexology
  • National Medical Academy of Postgraduate Education named after P.L.Shupik; Neurology Department #1
  • D.F.Chebotarev Institute of Gerontology NAMS;Depart of Age Physiology&Pathology of Nervous System
  • Royal Preston Hospital
  • Surrey and Borders NHS Foundation Trust; Brain Science Research Unit
  • Coventry and Warwickshire Partnership NHS Trust
  • St George's Hospital
  • Charing Cross Hospital
  • Manchester Royal Infirmary
  • Campus for Ageing and Vitality
  • John Radcliffe Hospital

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 105 in Clinical Dementia Rating-Sum of Boxes (CDR-SB) 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 105 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 105 on Cognition, as Assessed by Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog) (Subscale) 13 (ADAS-Cog-13)
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 105 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 105 on Cognition, as Assessed by Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog) (Subscale) 11 (ADAS-Cog-11)
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 105 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 105 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 105 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 105 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 105 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 105 on Function as Assessed by the 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 105 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 105 on Function as Assessed by the ADCS-instrumental (ADCS-iADL) Subscore
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 105 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 105 on a Measure of Dependence Derived 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 105 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 105 Assessed Using the Neuropsychiatric Inventory Questionnaire (NPI-Q)
The NPI-Q is an informant-based instrument that 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 and 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. The difference in mean change from Baseline to Week 105 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.
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 105 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 105 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.
EQ-5D Questionnaire Domain Score 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 105 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.
EQ-5D Questionnaire Domain Score 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 105 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 37 and 105.
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 a Post-dose sample was only collected at Week 13.
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 a Post-dose sample was only collected at Week 13.
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

First Posted
January 28, 2016
Last Updated
July 1, 2020
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT02670083
Brief Title
A Study Evaluating the Efficacy and Safety of Crenezumab Versus Placebo in Participants With Prodromal to Mild Alzheimer's Disease (AD).
Acronym
CREAD
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 this study, which indicated that Crenezumab was unlikely to meet its primary endpoint.
Study Start Date
March 22, 2016 (Actual)
Primary Completion Date
May 31, 2019 (Actual)
Study Completion Date
May 31, 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 final efficacy and safety assessment will be performed 52 weeks after the last crenezumab dose. Participants will then have the option to enter the Open Label Extension (OLE) study if eligible. Participants who do not enter the OLE study will have additional follow-up visits at 16 and 52 weeks after the last dose, primarily for safety and also for limited efficacy assessments.

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
813 (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 105 in Clinical Dementia Rating-Sum of Boxes (CDR-SB) 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 105 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 105
Secondary Outcome Measure Information:
Title
Change From Baseline to Week 105 on Cognition, as Assessed by Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog) (Subscale) 13 (ADAS-Cog-13)
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 105 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 105
Title
Change From Baseline to Week 105 on Cognition, as Assessed by Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog) (Subscale) 11 (ADAS-Cog-11)
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 105 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 105
Title
Change From Baseline to Week 105 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 105 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 105
Title
Change From Baseline to Week 105 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 105 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 105
Title
Change From Baseline to Week 105 on Function as Assessed by the 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 105 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 105
Title
Change From Baseline to Week 105 on Function as Assessed by the ADCS-instrumental (ADCS-iADL) Subscore
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 105 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 105
Title
Change From Baseline to Week 105 on a Measure of Dependence Derived 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 105 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 105
Title
Change From Baseline to Week 105 Assessed Using the Neuropsychiatric Inventory Questionnaire (NPI-Q)
Description
The NPI-Q is an informant-based instrument that 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 and 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. The difference in mean change from Baseline to Week 105 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 105
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 105 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 up to Week 105
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 105 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 up to Week 105
Title
EQ-5D Questionnaire Domain Score 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 105 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 up to Week 105
Title
EQ-5D Questionnaire Domain Score 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 105 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 up to Week 105
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 37 and 105.
Time Frame
Pre-infusion (0 hour), 60-90 minutes post-infusion on Day 1 Week 1 and on Week 25; Weeks 13, 37 (Pre-dose), 53, 77 and 105 (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 a Post-dose sample was only collected at Week 13.
Time Frame
Week 1 Day 1; Weeks 13, 25, 53, 77 and 105
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 a Post-dose sample was only collected at Week 13.
Time Frame
Week 1 Day 1; Weeks 13, 25, 53, 77 and 105
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
Banner Alzheimer's Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Pharmacology Research Inst
City
Encino
State/Province
California
ZIP/Postal Code
91316
Country
United States
Facility Name
Collaborative Neuroscience Network Inc.
City
Long Beach
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Alliance for Wellness, dba Alliance for Research
City
Long Beach
State/Province
California
ZIP/Postal Code
90807
Country
United States
Facility Name
Pharmacology Research Institute
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
Facility Name
USC Keck School Of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
UCLA Medical Center, Department of Neurology
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Pharmacology Research Inst
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
Facility Name
Shankle Clinic
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Stanford Univ Medical Center
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
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
Neurological Research Inst
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
North Bay Neuro Science Institute
City
Sebastopol
State/Province
California
ZIP/Postal Code
95472
Country
United States
Facility Name
Associated Neurologists PC - Danbury
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Facility Name
Institute for Neurodegenerative Disorders
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Yale University School Of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
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
Bradenton Research Center
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34205
Country
United States
Facility Name
Quantum Laboratories
City
Deerfield Beach
State/Province
Florida
ZIP/Postal Code
33064
Country
United States
Facility Name
Brain Matters Research, Inc.
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33445
Country
United States
Facility Name
Galiz Research, LLC
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Jacksonville Center For Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
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
Merritt - Island Medical Research
City
Merritt Island
State/Province
Florida
ZIP/Postal Code
32952
Country
United States
Facility Name
Miami Jewish Health Systems
City
Miami
State/Province
Florida
ZIP/Postal Code
33137
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
Johnnie B. Byrd Sr. Alzheimer's Center & Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Stedman Clinical Trials, LLC
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Compass Research
City
The Villages
State/Province
Florida
ZIP/Postal Code
32162
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Facility Name
NeuroStudies.net, LLC
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Alexian Brothers Neurosci Inst
City
Elk Grove Village
State/Province
Illinois
ZIP/Postal Code
60007
Country
United States
Facility Name
Southern Illinois University, School of Medicine
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
MidAmerica Neuroscience Institute
City
Prairie Village
State/Province
Kansas
ZIP/Postal Code
66206
Country
United States
Facility Name
Maine Research Associates
City
Auburn
State/Province
Maine
ZIP/Postal Code
04210
Country
United States
Facility Name
MMP Neurology
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04074
Country
United States
Facility Name
Springfield Neurology Associates
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01104
Country
United States
Facility Name
Precise Research Centers
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Facility Name
The Cognitive and Research Center of New Jersey
City
Springfield
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
Albany Medical Faculty Physicians COmmunity Division. The Neurology Group
City
Albany
State/Province
New York
ZIP/Postal Code
12206
Country
United States
Facility Name
Neurological Associates of Albany, PC
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Dent Neurological Institute
City
Amherst
State/Province
New York
ZIP/Postal Code
14226
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
South Shore Neurologic Associates P.C.
City
Patchogue
State/Province
New York
ZIP/Postal Code
11772
Country
United States
Facility Name
Behavioral Health Research
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28211
Country
United States
Facility Name
Guilford Neurologic Associates
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27401
Country
United States
Facility Name
Valley Medical Primary Care
City
Centerville
State/Province
Ohio
ZIP/Postal Code
45459
Country
United States
Facility Name
Insight Clinical Trials LLC
City
Shaker Heights
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Oklahoma Clinical Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Cutting Edge Research Group
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73116
Country
United States
Facility Name
Central States Research
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Summit Research Network Inc.
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Drexel Univ College of Med; Clinical Research Group
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
Facility Name
Abington Neurological Associates
City
Willow Grove
State/Province
Pennsylvania
ZIP/Postal Code
19090
Country
United States
Facility Name
Senior Adults Specialty Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78757
Country
United States
Facility Name
Kerwin Research Center, LLC
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
University of North Texas Health Science Center; Fort Worth Patient Care Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76107
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
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
The Queen Elizabeth Hospital; Neurology
City
Woodville
State/Province
South Australia
ZIP/Postal Code
5011
Country
Australia
Facility Name
Caulfield Hospital; Aged Psychiatry Research Unit
City
Caulfield
State/Province
Victoria
ZIP/Postal Code
3162
Country
Australia
Facility Name
Heidelberg Repatriation Hospital; Medical and Cognitive Research Centre
City
Heidelberg West
State/Province
Victoria
ZIP/Postal Code
3081
Country
Australia
Facility Name
Neurodegenerative Disorders Research; Neurology
City
West Perth
State/Province
Western Australia
ZIP/Postal Code
6005
Country
Australia
Facility Name
Konventhospital Barmherzige Brüder; Neurologie I
City
Linz
ZIP/Postal Code
4021
Country
Austria
Facility Name
UZ Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
ACIBADEM CITY CLINIC TOKUDA HOSPITAL EAD; Clinic of Neurology and Sleep Medicine
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
Alexandrovska hospital; Neurology Department
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Vancouver Hospital - UBC Hospital Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
Facility Name
Vancouver Island Health Authority
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 1J8
Country
Canada
Facility Name
Parkwood Hospital; Geriatric Medicine
City
London
State/Province
Ontario
ZIP/Postal Code
N6C 5J1
Country
Canada
Facility Name
Bruyere Continuing Care
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1N 5C8
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
Toronto Western Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Facility Name
Devonshire Clinical Research Inc.
City
Woodstock
State/Province
Ontario
ZIP/Postal Code
N4S 5P5
Country
Canada
Facility Name
CHA Hopital de I enfant-Jesus
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1J 1Z4
Country
Canada
Facility Name
ICIMED Instituto de Investigación en Ciencias Médicas
City
San Jose
ZIP/Postal Code
10108
Country
Costa Rica
Facility Name
Hospital Clínica Biblica
City
San José
ZIP/Postal Code
10101
Country
Costa Rica
Facility Name
Clinical Hospital Centre Zagreb;Clinic for Neurology
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Charles University, Medical faculty, Hradec Kralove ;Department of Neurology
City
Hradec Králové
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
General Teaching Hospital, Departmetn of Neurology
City
Praha
ZIP/Postal Code
110 00
Country
Czechia
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
Terveystalo Tampere
City
Tampere
ZIP/Postal Code
33100
Country
Finland
Facility Name
CRST Oy
City
Turku
ZIP/Postal Code
20520
Country
Finland
Facility Name
Hopital Avicenne; Neurologie
City
Bobigny
ZIP/Postal Code
93009
Country
France
Facility Name
Hopital neurologique Pierre Wertheimer - CHU Lyon; Neurologie
City
Bron
ZIP/Postal Code
69677
Country
France
Facility Name
Hopital Gui de Chauliac; Neurologie
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Hopital Lariboisiere
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
CHU Poitiers - Hopital La Miletrie
City
Poitiers
ZIP/Postal Code
86000
Country
France
Facility Name
Hopital Hautepierre; Centre dInvestigation Clinique
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Facility Name
CHU Toulouse - La Grave
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Neurologische Praxis Dr. Andrej Pauls
City
München
ZIP/Postal Code
80331
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
Universitätsklinikum Münster; Klinik und Poliklinik für Neurologie
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Steinwachs Klaus; Arztpraxis fur Neurologie u. Psychiatrie
City
Nürnberg
ZIP/Postal Code
90402
Country
Germany
Facility Name
Universitätsklinikum Rostock Zentrum für Nervenheilkunde
City
Rostock
ZIP/Postal Code
18147
Country
Germany
Facility Name
Universitätsklinikum Ulm; Klinik für Neurologie
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Studienzentrum Nordwest, Dr. med. Joachim Springub / Herr Wolfgang Schwarz
City
Westerstede
ZIP/Postal Code
26655
Country
Germany
Facility Name
Forschungszentrum Ruhr
City
Witten
ZIP/Postal Code
58455
Country
Germany
Facility Name
Prince of Wales Hospital; Dept. of Medicine & Therapeutics
City
Hong Kong
Country
Hong Kong
Facility Name
Queen Mary Hospital, Division of Geriatric Medicine
City
Hong Kong
Country
Hong Kong
Facility Name
Semmelweis University; Department of Neurology
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Szabolcs-Szatmár-Bereg Megyei Kórházak - Jósa András Oktatókórház; Pszichiátria
City
Nyíregyháza
ZIP/Postal Code
4400
Country
Hungary
Facility Name
University of Szeged; Department of Psychiatry
City
Szeged
ZIP/Postal Code
6725
Country
Hungary
Facility Name
Szent Borbala Korhaz; Neurologiai es Stroke Osztaly
City
Tatabánya
ZIP/Postal Code
2800
Country
Hungary
Facility Name
Jávorszky Ödön Kórház, Neurológia és stroke osztály
City
VAC
ZIP/Postal Code
2600
Country
Hungary
Facility Name
Fondazione Santa Lucia IRCCS; Neurologia e Riabilitazione Neurologica
City
Roma
State/Province
Lazio
ZIP/Postal Code
00179
Country
Italy
Facility Name
Ospedale San Giovanni Calibita Fatebenefratell;Neurologia
City
Roma
State/Province
Lazio
ZIP/Postal Code
00186
Country
Italy
Facility Name
Ente Ospedaliero Ospedali Galliera; Ambulatorio di Neurologia
City
Genova
State/Province
Liguria
ZIP/Postal Code
16128
Country
Italy
Facility Name
Casa di Cura Policlinico; Dipartimento di Scienze Neuroriabilitative
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20144
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
Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; S.C. Geriatria
City
Perugia
State/Province
Umbria
ZIP/Postal Code
06129
Country
Italy
Facility Name
Miyoshi Clinic of Neurology, Hananosato
City
Hiroshima
ZIP/Postal Code
728-0013
Country
Japan
Facility Name
National Hospital Organization Hiroshima-Nishi Medical Center
City
Hiroshima
ZIP/Postal Code
739-0696
Country
Japan
Facility Name
Rakuwakai Otowarehabilitation Hospital
City
Kyoto
ZIP/Postal Code
607-8113
Country
Japan
Facility Name
Mie University Hospital
City
Mie
ZIP/Postal Code
514-8507
Country
Japan
Facility Name
National Hospital Organization Matsumoto Medical Center
City
Nagano
ZIP/Postal Code
399-8701
Country
Japan
Facility Name
Saigata Medical Center
City
Niigata
ZIP/Postal Code
949-3193
Country
Japan
Facility Name
Katayama Medical Clinic
City
Okayama
ZIP/Postal Code
710-0813
Country
Japan
Facility Name
Tokyo Medical University Hospital
City
Tokyo
ZIP/Postal Code
160-0023
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
Chonnam National University Hospital
City
Gwangju
ZIP/Postal Code
61469
Country
Korea, Republic of
Facility Name
Inha University Hospital
City
Incheon
ZIP/Postal Code
22332
Country
Korea, Republic of
Facility Name
Konkuk University Medical Center
City
Seoul
ZIP/Postal Code
05030
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
KyungHee Medical Center
City
Seoul
ZIP/Postal Code
130-702
Country
Korea, Republic of
Facility Name
Ewha Womans University Mokdong Hospital; Dept of Neurology
City
Seoul
ZIP/Postal Code
158-710
Country
Korea, Republic of
Facility Name
Vilnius University Hospital Santariskiu Clinic
City
Vilnius
ZIP/Postal Code
08661
Country
Lithuania
Facility Name
Hospital Angeles de Culiacán, Neurociencias Estudios Clínicos SC
City
Culiacan
ZIP/Postal Code
80020
Country
Mexico
Facility Name
Hospital Uni; Dr. Jose E. Gonzalez
City
Monterrey
ZIP/Postal Code
64460
Country
Mexico
Facility Name
AVIX Investigación Clínica S.C
City
Monterrey
ZIP/Postal Code
64710
Country
Mexico
Facility Name
Hospital Universitario de Saltillo
City
Saltillo
ZIP/Postal Code
25000
Country
Mexico
Facility Name
Podlaskie Centrum Psychogeriatrii
City
Białystok
ZIP/Postal Code
15-756
Country
Poland
Facility Name
NZOZ NEURO-KARD Ilkowski i Partnerzy Sp. Partn. Lek
City
Poznań
ZIP/Postal Code
61-853
Country
Poland
Facility Name
NEURO-CARE Sp. z o.o. Sp. Komandytowa
City
Siemianowice Śląskie
ZIP/Postal Code
41-100
Country
Poland
Facility Name
Przychodnia Specjalistyczna PROSEN
City
Warszawa
ZIP/Postal Code
01-231
Country
Poland
Facility Name
Centrum Medyczne NeuroProtect
City
Warszawa
ZIP/Postal Code
01-684
Country
Poland
Facility Name
Optimum
City
Warszawa
ZIP/Postal Code
01-785
Country
Poland
Facility Name
Hospital Prof. Dr. Fernando Fonseca; Servico de Neurologia
City
Amadora
ZIP/Postal Code
2720-276
Country
Portugal
Facility Name
Hospital Beatriz Angelo; Servico de Neurologia
City
Loures
ZIP/Postal Code
2674-514
Country
Portugal
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
SBEI of HPI The 1st Moscow State Medical University n.a. I.M. Sechenov of MOH of RF
City
Moscow
ZIP/Postal Code
119021
Country
Russian Federation
Facility Name
City Clinical Hospital # 2 n.a. V.I. Razumovsky
City
Saratov
ZIP/Postal Code
410028
Country
Russian Federation
Facility Name
SHI City Psychoneurological Dispensary #7
City
St Petersburg
ZIP/Postal Code
190005
Country
Russian Federation
Facility Name
Russian Medical Military Academy n.a. S.M.Kirov; Neurology Department
City
St. Petersburg
ZIP/Postal Code
194044
Country
Russian Federation
Facility Name
University Medical Centre Maribor
City
Maribor
ZIP/Postal Code
2000
Country
Slovenia
Facility Name
Fundació ACE
City
BArcelon
State/Province
Barcelona
ZIP/Postal Code
08034
Country
Spain
Facility Name
Hospital Universitari de Bellvitge; Servicio de Neurologia
City
L'Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital Sant Joan de Deu; Servicio de Neurología
City
Manresa
State/Province
Barcelona
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
Clinica Universitaria de Navarra; Servicio de Neurología
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Complejo Asistencial Universitario de Salamanca; Servicio de Psiquiatría
City
Salamaca
State/Province
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Hospital General Universitario de Albacete; Servicio de Neurología
City
Albacete
Country
Spain
Facility Name
Hospital Vall d'Hebron; Servicio de Neurología
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitario de Burgos. Servicio de Neurología
City
Burgos
ZIP/Postal Code
09006
Country
Spain
Facility Name
Clinica Ruber, 4 planta; Servicio de Neurologia
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Universitario de La Princesa; Servicio de Neurología
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre; Servicio de Neurologia
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Regional Universitario Carlos Haya; Servicio de Neurologia
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Universitario Virgen de Arrixaca; Servicio de Neurología
City
Murcia
Country
Spain
Facility Name
Hospital Universitario la Fe; Servicio de Neurologia
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Servicio de Neurología Hospital Viamed Montecanal.
City
Zaragoza
ZIP/Postal Code
50012
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
Karolinska Uni Hospital, Huddinge; Dept. of Geriatric Med
City
Stockholm
ZIP/Postal Code
14186
Country
Sweden
Facility Name
Universitäres Zentrum für Altersmedizin und Rehabilitation
City
Basel
ZIP/Postal Code
4002
Country
Switzerland
Facility Name
Hacettepe University School of Medicine; Neurology
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Osmangazi University School of Medicine,Neurology Department
City
Eskişehir
ZIP/Postal Code
26480
Country
Turkey
Facility Name
Istanbul University Istanbul School of Medicine; Neurology
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
Facility Name
Ondokuz Mayis University School of Medicine; Neurology
City
Samsun
ZIP/Postal Code
55139
Country
Turkey
Facility Name
Regional mental hospital; Department of psychiatry, psychology and sexology
City
Lviv
State/Province
KIEV Governorate
ZIP/Postal Code
79021
Country
Ukraine
Facility Name
National Medical Academy of Postgraduate Education named after P.L.Shupik; Neurology Department #1
City
Kiev
ZIP/Postal Code
04112
Country
Ukraine
Facility Name
D.F.Chebotarev Institute of Gerontology NAMS;Depart of Age Physiology&Pathology of Nervous System
City
Kiev
ZIP/Postal Code
04114
Country
Ukraine
Facility Name
Royal Preston Hospital
City
Blackburn
ZIP/Postal Code
PR2 9HT
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
Coventry and Warwickshire Partnership NHS Trust
City
Coventry
ZIP/Postal Code
CV6 6NY
Country
United Kingdom
Facility Name
St George's Hospital
City
London
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
Facility Name
Charing Cross Hospital
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
Campus for Ageing and Vitality
City
Newcastle Upon Tyne
ZIP/Postal Code
NE4 6BE
Country
United Kingdom
Facility Name
John Radcliffe Hospital
City
Oxford
ZIP/Postal Code
OX3 9DU
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 Evaluating the Efficacy and Safety of Crenezumab Versus Placebo in Participants With Prodromal to Mild Alzheimer's Disease (AD).

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