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An Efficacy and Safety Study of Lanabecestat (LY3314814) in Early Alzheimer's Disease (AMARANTH)

Primary Purpose

Alzheimer´s Disease

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Lanabecestat
Placebo
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer´s Disease focused on measuring Alzheimer's disease, Dementia, Brain Diseases, Neurogenerative Diseases, Central Nervous System Diseases, Nervous System Diseases, Mental Disorders, Delirium, Dementia, Amnestic, Cognitive Disorders, Tauopathies

Eligibility Criteria

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

Inclusion Criteria:

  • Gradual and progressive change in the participant's memory function over more than 6 months, reported by participant and study partner
  • Mini-Mental State Examination score of 20-30 inclusive at screening
  • Objective impairment in memory as evaluated by memory test performed at screening
  • For a diagnosis of mild Alzheimer's Disease (AD), participant meets the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria for probable AD
  • For a diagnosis of MCI due to AD, participant meets NIA-AA criteria for MCI due to AD

Exclusion Criteria:

  • Significant neurological disease affecting the central nervous system, other than AD, that may affect cognition or ability to complete the study, including but not limited to, other dementias, serious infection of the brain, Parkinson´s disease, or epilepsy or recurrent seizures
  • History of clinically evident stroke, or multiple strokes based on history or imaging results
  • History of clinically important carotid or vertebrobasilar stenosis or plaque
  • History of multiple concussions with sustained cognitive complaints or objective change in neuropsychological function in the last 5 years
  • Participants with a current Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition diagnosis of Major Depressive Disorder or any current primary psychiatric diagnosis other than AD if, in the judgment of the investigator, the psychiatric disorder or symptom is likely to confound interpretation of drug effect, affect cognitive assessments, or affect the participant´s ability to complete the study
  • History of alcohol or drug abuse or dependence (except nicotine dependence) within 2 years before the screening
  • Within 1 year before the screening or between screening and baseline, any of the following: myocardial infarction; moderate or severe congestive heart failure, New York Heart Association class III or IV; hospitalization for, or symptom of, unstable angina; syncope due to orthostatic hypotension or unexplained syncope; known significant structural heart disease (eg, significant valvular disease, hypertrophic cardiomyopathy), or hospitalization for arrhythmia
  • Congenital QT prolongation
  • History of cancer within the last 5 years, with the exception of non-metastatic basal and/or squamous cell carcinoma of the skin, in situ cervical cancer, non-progressive prostate cancer or other cancers with low-risk of recurrence or spread
  • Current serious or unstable clinically important systemic illness that, in the judgment of the investigator, is likely to affect cognitive assessment, deteriorate, or affect the participant's safety or ability to complete the study, including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic, or hematologic disorders

Sites / Locations

  • Banner Alzheimer's Institute
  • St Josephs Hospital and Medical Center
  • Banner Sun Health Research Institute
  • Territory Neurology & Research Institute
  • Positron Research International
  • Alliance Research Centers
  • Senior Clinical Trials, Inc.
  • Collaborative Neuroscience Network - CNS
  • Pacific Research Network Inc
  • San Francisco Clinical Research Center
  • Mile High Research Center
  • Institute for Neurodegenerative Disorders
  • Georgetown University Medical Center
  • Brain Matters Research
  • Direct Helpers Medical Center
  • Berma Research
  • Galiz Research
  • MaxBlue Institute
  • Alzheimer's Research and Treatment Center
  • Miami Jewish Health Systems
  • Medical Research Center
  • Allied Biomedical Research Institute, Inc.
  • Advance Medical Research Institute
  • New Horizon Research Center
  • JDH Medical Group, LLC
  • Compass Research
  • IMIC, Inc.
  • Suncoast Neuroscience Associates
  • Roskamp Institute
  • Infinity Clinical Research, LLC
  • Stedman Clinical Trials
  • Olympian Clinical Research
  • Compass Research
  • Premiere Research Institute at Palm Beach Neurology
  • The Multiple Sclerosis Center of Atlanta
  • Atlanta Center of Medical Research
  • Carman Research
  • University of Chicago Medical Center
  • Alexian Brothers Medical Center
  • Community Clinical Research Center
  • Indiana University School of Medicine
  • ActivMed Practices & Research, Inc
  • Boston Center for Memory
  • Springfield Neurology Associates
  • Hattiesburg Clinic
  • Millennium Psychiatric Associates, LLV
  • St. Louis Clinical Trials, LC
  • Memory Enhancement Center of America, Inc.
  • AdvanceMed Research
  • Alzheimer's Research Company
  • The Cognitive and Research Center of NJ
  • Advanced Memory Research Institute of New Jersey
  • Bio Behavioral Health
  • Neurology Specialists of Monmouth County
  • Integrative Clinical Trials, LLC
  • SPRI Clinical Trials, LLC.
  • Alzheimer's Disease and Memory Disorders Center
  • Empire Neurology, PC
  • Clinilabs, Inc (New York)
  • Columbia University Medical Center
  • University of Rochester
  • Alzheimer's Memory Center
  • Valley Medical Primary Care
  • Christ Hospital
  • Ohio State University Medical Center
  • The Corvallis Clinic P.C.
  • Lehigh Valley Hospital
  • Rhode Island Mood & Memory Research Institute
  • Roper St. Francis Healthcare
  • Radiant Research
  • Quillen College of Medicine, East TN State University
  • Senior Adults Specialty Research Inc
  • Texas Health Physicians Group
  • Medical Group of Texas
  • University of Texas Health Services Center - Houston
  • University of Utah School of Medicine
  • The Memory Clinic
  • Southern Neurology
  • Griffith University
  • Royal Adelaide Hospital
  • Box Hill Hospital
  • Delmont Private Hospital
  • Heidelberg Repatriation Hospital
  • The Florey Institute of Neuroscience and Mental Health
  • Australian Alzheimer's Research Foundation
  • Neuro Trials Victoria Pty Ltd
  • Jessa Ziekenhuis
  • Hopital Universitaire Brugmann Brussel
  • Cliniques Universitaires Saint-Luc
  • Hospital Universitaire Erasme Brussel
  • Universitair Ziekenhuis Antwerpen
  • Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
  • Heilig Hartziekenhuis
  • The Medical Arts Health Research Group
  • Okanagan Clinical Trials
  • University of British Columbia
  • Royal Jubilee Hospital
  • True North Clinical Research Halifax, LLC
  • Bruyere Continuing Care
  • Kawartha Regional Memory Clinic
  • Toronto Memory Program
  • Toronto Western Hospital
  • CSSS-Institut Universitaire Gériatric de Sherbrooke
  • Clinique de la Memoire de l'Outaouais
  • NeuroSearch Developements
  • Hopital Maisonneure-Rosemount
  • Hopital de L'Enfant Jesus
  • Q&T Research Sherbrooke Inc
  • CHU de Toulouse Hopital Purpan
  • Hopital Neuro Pierre Wertheimer
  • CHU Dijonon
  • CHRU Lille - Hopital Roger Salengro
  • CHU Hopital de la Timone
  • Chu de Nantes Hopital Laennec
  • Hopital Broca
  • Hopital de la Pitie Salpetriere
  • Hopital Lariboisière
  • CHU de Toulouse
  • Hopital des Charpennes
  • Universitätsklinikum Tübingen
  • Universitätsklinikum Ulm
  • Studien und Gedächtniszentrum München
  • Klinikum Rechts der Isar der TU München
  • Institut fur Psychogerontologie
  • Neurozentrum Prien
  • Institut für Neuropsychiatrie INP3
  • Studienzentrum Nord-West
  • Praxis Dr. Lauter
  • St Josef-Hospital Bochum
  • Universitätsklinikum Bonn
  • Gemeinschaftspraxis für Neurologie Prof. Gereon Nelles
  • Universitätsklinikum Köln
  • Neurologische Praxis Siegen
  • Universitätsklinikum des Saarlandes
  • Martin-Luther-Universität Halle-Wittenberg
  • Universitätsklinikum Otto-von-Guericke-Universität
  • Pharmakologisches Studienzentrum Chemnitz
  • Arztpraxis Dr. Christian Oehlwein
  • Gemeinschaftspraxis Dr. R. Ehret & Dr. W. von Pannwitz
  • Charité Universitätsmedizin Berlin
  • Charité Universitätsmedizin Berlin
  • PTE KK Pszichiatriai es Pszichoterapias Klinika
  • Semmelweis Medical University
  • Del-pesti Centrumkorház - Orszagos Hematologiai és Infektologiai Intezet
  • Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz
  • Debreceni Egyetem Klinikai Kozpont
  • Univerisity of Szeged
  • Ospedale Degli Infermi ASR USSL 12
  • Azienda Ospedaliera San Gerardo
  • Fondazione San Raffaele Giglio di Cefalu
  • Universita Di Pisa
  • Università Politecnica delle Marche Torrette
  • IRCCS San Giovanni di Dio Fatebenefratelli
  • Fondazione Universitaria degli Studi G D'Annunzio
  • Ente Ospedaliero Ospedali Galliera
  • Fondazione IRCCS Ca'Granda Ospedale Maggiore Policinico
  • Nuovo Ospedale Civile Sant'Agostino Estense
  • Policlinico Univ. Agostino Gemelli
  • Dip.to Med. Sperimentale -Polic.Umberto I -Univ. La Sapienza
  • Ospedale San Giovanni Calibita Fatebenefratelli
  • Policlinico Ospedale S. Andrea
  • Azienda Ospedaliera Citta della Salute della Scienza Torino
  • National Institute for Longevity Sciences NCGG
  • National Chiba-East-Hospital
  • National Hospital Organization Asahikawa Medical Center
  • Tsukuba University Hospital
  • Iwate Medical University Hospital
  • Shonan Kamakura General Hospital
  • Nihon Kokan Hospital
  • Yokohama City University Hospital
  • Kyoto Prefectural University of Medicine
  • Rakuwakai Otowarehabilitation Hospital
  • Ina Central Hospital
  • Matsumoto Medical Center
  • Katayama Medical Clinic
  • Shiroma Clinic
  • Koshokai aino hospital
  • Sakaguchi Clinic
  • National Sanatorium Toneyama Hospital
  • Saitama Medical University Hospital
  • Nippon Medical School Hospital
  • The University of Tokyo Hospital
  • Nozomi Memory Clinic
  • Sangenjaya Nakamura Mental Clinic
  • Kanauchi Medical Clinic
  • Tokyo Women's Medical University Hospital
  • Memory Clinic Ochanomizu
  • National Sanatorium Hokuriku Hospital
  • Fukuoka University Hospital
  • Kyoto University Hospital
  • Kyoto Minami Hospital
  • Utano Hospital
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Dong-A University Medical Center
  • Seoul National University Bundang Hospital
  • The Catholic University of Korea-Bucheon St. Mary's Hospital
  • Hanyang University Guri Hospital
  • Gachon University Gil Medical Center
  • Inha University Hospital
  • Asan Medical Center
  • Samsung Medical Center
  • Seoul St. Mary's Hospital
  • NZOZ Wroclawskie Centrum Alzheimerowskie
  • Medycyna Milorzab
  • Podlaskie Centrum Psychogeriatrii
  • NZOZ Dom Sue Ryder - Pallmed Sp. z o.o.
  • NZOZ Wielospecjalistyczna Poradnia Lekarska
  • Specjalistyczna Praktyka Lekarska prof. Grzegorz Opala
  • Centrum Zdrowia Psychicznego
  • Centrum Neurologii Klinicznej
  • NZOZ Neuromed M. I M. Nastaj sp. P.
  • Instytut Medycyny Wsi
  • NEURO-CARE Sp. z o.o. Sp. Komandytowa
  • Centrum Medyczne
  • Centralny Szpital Kliniczny MSW
  • Santa Cruz Behavioral PSC
  • Ivonne Z. Jimenez-Velazquez, MD
  • Instituto de Neurologia Dra. Ivonne Fraga
  • Michel A. Woodbury-Farina, MD.
  • SC Med Life SA
  • SC Centrul Medical Sana SRL
  • Policlinica CCBR S.R.L.
  • SC Med Life SA
  • Hospital General Universitario de Elche
  • Hospital General de Catalunya
  • Hospital Virgen Del Puerto
  • Hospital Universitario De Getafe
  • Hospital Puerta De Hierro
  • Centro de Atencion Especializada (CAE) OROITU
  • Hospital del Mar
  • Hospital Santa Creu I Sant Pau
  • Fundacion ACE-Institut Catala de Neurociences Aplicades
  • Hospital Clinic de Barcelona
  • Hospital Universitari de Bellvitge
  • Hospital Reina Sofia
  • Hospital De La Princesa
  • Hospital Universitario Ramon y Cajal
  • Hospital Son Espases
  • Hospital Univ Sant Joan de Reus, S.A.
  • Fundacion CITA Alzheimer
  • Hospital Doctor Peset
  • Hospital Universitario La Fe de Valencia
  • Plymouth Hospitals NHS Trust
  • Cognitive Treatment & Research Unit
  • Southern Health NHS
  • MAC UK Neuroscience Ltd
  • MAC Clinical Research
  • MAC Clinical Research
  • West London Mental Health NHS Trust
  • Glasgow Memory Clinic
  • Hammersmith Hospital
  • Guildford Nuffield Hospital
  • Re-Cognition Health Ltd
  • MAC Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Lanabecestat 20 milligrams (mg)

Lanabecestat 50 mg

Placebo

Arm Description

Lanabecestat 20 mg given orally once daily for 104 weeks.

Lanabecestat 50 mg given orally once daily for 104 weeks.

Placebo given orally once daily for 104 weeks.

Outcomes

Primary Outcome Measures

Change From Baseline on the 13-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13)
ADAS-Cog13 (13-item version of ADAS-Cog) is a psychometric instrument that evaluates word recall, ability to follow commands, constructional praxis, naming, ideational praxis, orientation, word recognition, memory, comprehension of spoken language, word-finding, and language ability, with a measure of delayed word recall and concentration/ distractibility. The total score of the 13-item scale ranges from 0 to 85, with an increase in score indicating cognitive worsening. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with factors for treatment, visit, treatment-by-visit interaction, disease status at baseline, apolipoprotein E4 (APOE4) status, acetylcholinesterase inhibitor (AChEI) use at baseline, pooled country, and covariates for baseline ADAS-Cog13 total score, age at baseline, and baseline ADAS-Cog13 total score-by-visit interaction.

Secondary Outcome Measures

Change From Baseline on the Alzheimer´s Disease Cooperative Study Activities of Daily Living Inventory Instrumental Items (ADCS-iADL)
The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant's caregiver. The ADCS-ADL measures both basic and instrumental activities of daily living by participants. The range for the ADCS-iADL is 0-59 with higher scores reflecting better performance. LS Mean was determined by MMRM model with factors for treatment, visit, treatment-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, pooled country, and covariates for baseline for baseline iADL score, age at baseline, and baseline iADL score-by-visit interaction.
Change From Baseline on the Functional Activities Questionnaire (FAQ) Score
FAQ is a 10-item, caregiver-based questionnaire and was administered to the study partner who was asked to rate the participant's ability to perform a variety of activities ranging from writing checks, assembling tax records, shopping, playing games, food preparation, traveling, keeping appointments, traveling out of neighborhood, keeping track of current events and understanding media. FAQ total score was calculated by adding the scores from each of the 10 items. Each activity is rated on a scale from 0 to 3 (Never did and would have difficulty now = 1; Never did [the activity] but could do now = 0; Normal = 0; Has difficulty but does by self = 1; Requires assistance = 2; Dependent = 3). FAQ scale is 0 to 30, with higher scores indicating greater impairment. LS Mean was calculated by MMRM with factors for treatment, visit, treatment-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline and pooled country.
Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) Score
The iADRS is a composite that measures both cognition and function. The iADRS comprises scores form the ADAS- Cog and the ADCS-iADL. The iADRS is calculated as a linear combination of the total scores of the ADAS-Cog13 (score range 0 to 85 with higher scores reflecting worse performance) and the ADCS-iADL (score range from 0-59 with higher scores reflecting better performance). The iADRS score ranges from 0 to 144 with higher scores indicating greater impairment. LS Mean was determined by MMRM methodology with factors for treatment, visit, treatment-by- visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, pooled country, and covariates for baseline iADRS13 total score, age at baseline, and baseline iADRS13 total score-by-visit interaction.
Change From Baseline on the Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score
The CDR-SB is a rater administered scale and impairment is scored in of the following categories: memory, orientation, judgment and problem solving, community affairs, home and hobbies and personal care. Impairment is scored on a scale in which no dementia = 0, questionable dementia = 0.5, mild dementia = 1, moderate dementia = 2 and severe dementia = 3. The 6 individual category ratings, or "box scores", were added together to give the CDR-Sum of Boxes which ranges from 0-18, with higher scores indicating greater impairment. LS Mean was determined by MMRM methodology with factors for treatment, visit, treatment-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, pooled country, and covariates for baseline CDR-SB score, age at baseline, and baseline CDR-SB score-by-visit interaction.
Time to Progression as Measured by Loss of Clinical Dementia Rating (CDR) Global Score Stage
The CDR global score is a composite score calculated using the Washington University CDR-assignment algorithm applied to the 6 individual domain box scores (Morris 1993). The memory domain is considered the primary category that drives the CDR global outcome, and all other domains are secondary. The CDR global score ranges from 0 to 3 (0 = no dementia, 0.5 = questionable dementia, 1 = mild dementia, 2 = moderate dementia, 3 = severe dementia).
Change From Baseline in Neuropsychiatric Inventory (NPI) Score
The NPI is a questionnaire administered to caregivers that quantifies behavioral changes. Each of the 12 behavioral domains the caregiver reports as present are scored for Frequency, scale: 1 (Occasionally) to 4 (Very Frequently), and Severity, scale: 1 (Mild) to 3 (Severe). If the domain is reported by the caregiver as 'Not Affected,' that domain is scored as 0. The individual domain scores are calculated by multiplying the frequency times the severity for each domain. NPI Total Score is calculated by adding the individual domain scores together for all 12 domains, with a scores range from 0 to 144, with higher scores indicating greater severity of neuropsychiatric disturbance. LS Mean was determined by MMRM methodology with factors for treatment, visit, treatment-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, pooled country, and covariates for baseline NPI score, age at baseline, and baseline NPI score-by-visit interaction.
Change From Baseline on the Mini-Mental State Examination (MMSE)
The MMSE is an instrument used to assess a participant's global cognitive function. The MMSE assesses orientation to time and place, immediate and delayed recall of words, attention and calculation, language (naming, comprehension and repetition), and spatial ability (copying a figure). The range for MMSE total Score is 0 to 30, with a higher score indicating better cognitive performance. LS mean was determined by MMRM methodology with factors for treatment, visit, treatment-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, pooled country, and covariates for baseline MMSE total score, age at baseline, and baseline MMSE total score-by-visit interaction.
Pharmacodynamics (PD): Percent Change From Baseline in Concentration of Cerebrospinal Fluid (CSF) Biomarker Amyloid Beta (Aβ)1-42
Concentration of the peptide Aβ 1-42 in plasma measured by validated immunoassay. LS Mean was determined by Analysis of covariance (ANCOVA) with last observation carried forward (LOCF), terms for treatment, baseline biomarker and age at baseline.
PD: Percent Change From Baseline in Concentration of CSF Biomarker Aβ1-40
Concentration of the peptide Aβ 1-40 in plasma measured by immunoassay. LS Mean was determined by ANCOVA with LOCF (last observation carried forward), terms for treatment, baseline biomarker and age at baseline.
Change From Baseline in CSF Total Tau
Cerebrospinal fluid samples are collected for analysis of concentration total tau. LS Mean was determined by ANCOVA with LOCF and with factors for treatment, disease status at baseline, baseline biomarker and age at baseline.
Change From Baseline in CSF Phosphorylated Tau
Cerebrospinal fluid samples are collected for analysis of concentrations of phosphorylated tau. LS Mean was determined by ANCOVA with LOCF and with factors for treatment, disease status at baseline, baseline biomarker and age at baseline.
Change From Baseline in Brain Amyloid Burden Using Florbetapir Amyloid Positron Emission Tomography (PET) Scan
Amyloid deposition in the brain is one of the defining neuropathologic findings of Alzheimer's disease. Florbetapir exhibits high affinity specific binding to amyloid plaques. The change from baseline was measured as average standard uptake value ratio (SUVr) in prespecified regions of interest (ROI) assessed by florbetapir amyloid PET imaging in a subset of participants. The Centiloid scale standardizes quantitative brain amyloid PET results to allow cross-tracer and cross-methodology comparisons. The Centiloid scale anchor points are 0 and 100, where 0 represents a high-certainty amyloid negative scan and 100 represents the amount of global amyloid deposition found in a typical AD scans. Florbetapir SUVr was converted to the Centiloid scale using the following conversion: Florbetapir Centiloids = 183 x SUVr - 177. LS Mean was determined by ANCOVA methodology with factors for treatment, disease status at baseline, baseline biomarker and age at baseline.
Change From Baseline in Tau PET ((Flortaucipir F18)
Tau PET tracer (flortaucipir F18) longitudinal study measured whether lanabecestat, in participants with mild AD dementia, affected tau density and distribution over time. The outcome reported is the composite summary of the standard uptake value ratio (SUVR) normalized to the signal intensity in white matter. Annualized change is derived as change at LOCF divided by (LOCF date - baseline date) multiplied by 365. LS Mean was determined by ANCOVA methodology with factors for treatment, disease status at baseline, baseline biomarker and age at baseline. Baseline defined to be within 28 days of starting study drug.
Change From Baseline in Brain Metabolism Using Fluorodeoxyglucose (FDG)
Fluorodeoxyglucose (FDG) PET evaluates the regional brain metabolic rates for glucose as a sensitive, in vivo metabolic index of brain function. The outcome reported is the composite summary of the standard uptake value ratio (SUVR) normalized to the pons + vermis assessed with composite meta and composite meta automated anatomical labeling atlas (ALL). Annualized change is derived as change at LOCF divided by (LOCF date - baseline date) multiplied by 365. LS Mean was determined by ANCOVA methodology with factors for treatment, disease status at baseline, baseline biomarker and age at baseline. Baseline defined to be within 28 days of starting study drug.
Change From Baseline in Whole Brain Volume
Magnetic resonance imaging (MRI) was used to evaluate the effect of lanabecestat on whole brain volumes. Annualized change is derived as change at LOCF divided by (LOCF date - baseline date) multiplied by 365. LS Mean was determined by ANCOVA methodology with factors for treatment, baseline vMRI, intracranial volume, disease status at baseline and age at baseline.
Pharmacokinetics (PK): Plasma Concentration of Lanabecestat

Full Information

First Posted
September 18, 2014
Last Updated
November 19, 2019
Sponsor
AstraZeneca
Collaborators
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT02245737
Brief Title
An Efficacy and Safety Study of Lanabecestat (LY3314814) in Early Alzheimer's Disease
Acronym
AMARANTH
Official Title
A 24-month, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Efficacy, Safety, Tolerability, Biomarker, and Pharmacokinetic Study of AZD3293 in Early Alzheimer's Disease (The AMARANTH Study)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Terminated
Why Stopped
An independent assessment concluded the trial was not likely to meet the primary endpoint upon completion and therefore, trial stopped for futility
Study Start Date
September 30, 2014 (Actual)
Primary Completion Date
October 4, 2018 (Actual)
Study Completion Date
October 4, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
Collaborators
Eli Lilly and Company

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to assess the efficacy and safety of lanabecestat compared with placebo administered for 104 weeks in the treatment of early Alzheimer´s disease. The study will test the hypothesis that lanabecestat is a disease-modifying treatment for participants with early Alzheimer´s disease, defined as the continuum of participants with mild cognitive impairment (MCI) due to Alzheimer´s disease and participants diagnosed with mild dementia of the Alzheimer´s type, as measured by change from baseline on the 13-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) score at week 104 in each of the 2 lanabecestat treatment groups compared with placebo.
Detailed Description
Participants who meet other study entry requirements will be required to undergo either an amyloid positron emission tomography (PET) scan or a lumbar puncture for cerebrospinal fluid (CSF) sampling at screening to document presence of abnormal levels of brain and CSF amyloid for study inclusion. The study includes 2 sub-studies: the participants that undergo a PET scan at screening will be included in the PET-substudy, and participants who undergo a lumbar puncture at screening will be included in the CSF substudy until each of these substudies are completed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer´s Disease
Keywords
Alzheimer's disease, Dementia, Brain Diseases, Neurogenerative Diseases, Central Nervous System Diseases, Nervous System Diseases, Mental Disorders, Delirium, Dementia, Amnestic, Cognitive Disorders, Tauopathies

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
2218 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lanabecestat 20 milligrams (mg)
Arm Type
Experimental
Arm Description
Lanabecestat 20 mg given orally once daily for 104 weeks.
Arm Title
Lanabecestat 50 mg
Arm Type
Experimental
Arm Description
Lanabecestat 50 mg given orally once daily for 104 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo given orally once daily for 104 weeks.
Intervention Type
Drug
Intervention Name(s)
Lanabecestat
Other Intervention Name(s)
LY3314814, AZD3293
Intervention Description
Administered orally
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered orally
Primary Outcome Measure Information:
Title
Change From Baseline on the 13-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13)
Description
ADAS-Cog13 (13-item version of ADAS-Cog) is a psychometric instrument that evaluates word recall, ability to follow commands, constructional praxis, naming, ideational praxis, orientation, word recognition, memory, comprehension of spoken language, word-finding, and language ability, with a measure of delayed word recall and concentration/ distractibility. The total score of the 13-item scale ranges from 0 to 85, with an increase in score indicating cognitive worsening. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with factors for treatment, visit, treatment-by-visit interaction, disease status at baseline, apolipoprotein E4 (APOE4) status, acetylcholinesterase inhibitor (AChEI) use at baseline, pooled country, and covariates for baseline ADAS-Cog13 total score, age at baseline, and baseline ADAS-Cog13 total score-by-visit interaction.
Time Frame
Baseline, Week 104
Secondary Outcome Measure Information:
Title
Change From Baseline on the Alzheimer´s Disease Cooperative Study Activities of Daily Living Inventory Instrumental Items (ADCS-iADL)
Description
The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant's caregiver. The ADCS-ADL measures both basic and instrumental activities of daily living by participants. The range for the ADCS-iADL is 0-59 with higher scores reflecting better performance. LS Mean was determined by MMRM model with factors for treatment, visit, treatment-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, pooled country, and covariates for baseline for baseline iADL score, age at baseline, and baseline iADL score-by-visit interaction.
Time Frame
Baseline, Week 104
Title
Change From Baseline on the Functional Activities Questionnaire (FAQ) Score
Description
FAQ is a 10-item, caregiver-based questionnaire and was administered to the study partner who was asked to rate the participant's ability to perform a variety of activities ranging from writing checks, assembling tax records, shopping, playing games, food preparation, traveling, keeping appointments, traveling out of neighborhood, keeping track of current events and understanding media. FAQ total score was calculated by adding the scores from each of the 10 items. Each activity is rated on a scale from 0 to 3 (Never did and would have difficulty now = 1; Never did [the activity] but could do now = 0; Normal = 0; Has difficulty but does by self = 1; Requires assistance = 2; Dependent = 3). FAQ scale is 0 to 30, with higher scores indicating greater impairment. LS Mean was calculated by MMRM with factors for treatment, visit, treatment-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline and pooled country.
Time Frame
Baseline, Week 104
Title
Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) Score
Description
The iADRS is a composite that measures both cognition and function. The iADRS comprises scores form the ADAS- Cog and the ADCS-iADL. The iADRS is calculated as a linear combination of the total scores of the ADAS-Cog13 (score range 0 to 85 with higher scores reflecting worse performance) and the ADCS-iADL (score range from 0-59 with higher scores reflecting better performance). The iADRS score ranges from 0 to 144 with higher scores indicating greater impairment. LS Mean was determined by MMRM methodology with factors for treatment, visit, treatment-by- visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, pooled country, and covariates for baseline iADRS13 total score, age at baseline, and baseline iADRS13 total score-by-visit interaction.
Time Frame
Baseline, Week 104
Title
Change From Baseline on the Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score
Description
The CDR-SB is a rater administered scale and impairment is scored in of the following categories: memory, orientation, judgment and problem solving, community affairs, home and hobbies and personal care. Impairment is scored on a scale in which no dementia = 0, questionable dementia = 0.5, mild dementia = 1, moderate dementia = 2 and severe dementia = 3. The 6 individual category ratings, or "box scores", were added together to give the CDR-Sum of Boxes which ranges from 0-18, with higher scores indicating greater impairment. LS Mean was determined by MMRM methodology with factors for treatment, visit, treatment-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, pooled country, and covariates for baseline CDR-SB score, age at baseline, and baseline CDR-SB score-by-visit interaction.
Time Frame
Baseline, Week 104
Title
Time to Progression as Measured by Loss of Clinical Dementia Rating (CDR) Global Score Stage
Description
The CDR global score is a composite score calculated using the Washington University CDR-assignment algorithm applied to the 6 individual domain box scores (Morris 1993). The memory domain is considered the primary category that drives the CDR global outcome, and all other domains are secondary. The CDR global score ranges from 0 to 3 (0 = no dementia, 0.5 = questionable dementia, 1 = mild dementia, 2 = moderate dementia, 3 = severe dementia).
Time Frame
Baseline through Loss of 1 Global Stage or Week 104
Title
Change From Baseline in Neuropsychiatric Inventory (NPI) Score
Description
The NPI is a questionnaire administered to caregivers that quantifies behavioral changes. Each of the 12 behavioral domains the caregiver reports as present are scored for Frequency, scale: 1 (Occasionally) to 4 (Very Frequently), and Severity, scale: 1 (Mild) to 3 (Severe). If the domain is reported by the caregiver as 'Not Affected,' that domain is scored as 0. The individual domain scores are calculated by multiplying the frequency times the severity for each domain. NPI Total Score is calculated by adding the individual domain scores together for all 12 domains, with a scores range from 0 to 144, with higher scores indicating greater severity of neuropsychiatric disturbance. LS Mean was determined by MMRM methodology with factors for treatment, visit, treatment-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, pooled country, and covariates for baseline NPI score, age at baseline, and baseline NPI score-by-visit interaction.
Time Frame
Baseline, Week 104
Title
Change From Baseline on the Mini-Mental State Examination (MMSE)
Description
The MMSE is an instrument used to assess a participant's global cognitive function. The MMSE assesses orientation to time and place, immediate and delayed recall of words, attention and calculation, language (naming, comprehension and repetition), and spatial ability (copying a figure). The range for MMSE total Score is 0 to 30, with a higher score indicating better cognitive performance. LS mean was determined by MMRM methodology with factors for treatment, visit, treatment-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, pooled country, and covariates for baseline MMSE total score, age at baseline, and baseline MMSE total score-by-visit interaction.
Time Frame
Baseline, Week 104
Title
Pharmacodynamics (PD): Percent Change From Baseline in Concentration of Cerebrospinal Fluid (CSF) Biomarker Amyloid Beta (Aβ)1-42
Description
Concentration of the peptide Aβ 1-42 in plasma measured by validated immunoassay. LS Mean was determined by Analysis of covariance (ANCOVA) with last observation carried forward (LOCF), terms for treatment, baseline biomarker and age at baseline.
Time Frame
Baseline, Week 97
Title
PD: Percent Change From Baseline in Concentration of CSF Biomarker Aβ1-40
Description
Concentration of the peptide Aβ 1-40 in plasma measured by immunoassay. LS Mean was determined by ANCOVA with LOCF (last observation carried forward), terms for treatment, baseline biomarker and age at baseline.
Time Frame
Baseline, Week 97
Title
Change From Baseline in CSF Total Tau
Description
Cerebrospinal fluid samples are collected for analysis of concentration total tau. LS Mean was determined by ANCOVA with LOCF and with factors for treatment, disease status at baseline, baseline biomarker and age at baseline.
Time Frame
Baseline, Week 97
Title
Change From Baseline in CSF Phosphorylated Tau
Description
Cerebrospinal fluid samples are collected for analysis of concentrations of phosphorylated tau. LS Mean was determined by ANCOVA with LOCF and with factors for treatment, disease status at baseline, baseline biomarker and age at baseline.
Time Frame
Baseline, Week 97
Title
Change From Baseline in Brain Amyloid Burden Using Florbetapir Amyloid Positron Emission Tomography (PET) Scan
Description
Amyloid deposition in the brain is one of the defining neuropathologic findings of Alzheimer's disease. Florbetapir exhibits high affinity specific binding to amyloid plaques. The change from baseline was measured as average standard uptake value ratio (SUVr) in prespecified regions of interest (ROI) assessed by florbetapir amyloid PET imaging in a subset of participants. The Centiloid scale standardizes quantitative brain amyloid PET results to allow cross-tracer and cross-methodology comparisons. The Centiloid scale anchor points are 0 and 100, where 0 represents a high-certainty amyloid negative scan and 100 represents the amount of global amyloid deposition found in a typical AD scans. Florbetapir SUVr was converted to the Centiloid scale using the following conversion: Florbetapir Centiloids = 183 x SUVr - 177. LS Mean was determined by ANCOVA methodology with factors for treatment, disease status at baseline, baseline biomarker and age at baseline.
Time Frame
Baseline, Week 104
Title
Change From Baseline in Tau PET ((Flortaucipir F18)
Description
Tau PET tracer (flortaucipir F18) longitudinal study measured whether lanabecestat, in participants with mild AD dementia, affected tau density and distribution over time. The outcome reported is the composite summary of the standard uptake value ratio (SUVR) normalized to the signal intensity in white matter. Annualized change is derived as change at LOCF divided by (LOCF date - baseline date) multiplied by 365. LS Mean was determined by ANCOVA methodology with factors for treatment, disease status at baseline, baseline biomarker and age at baseline. Baseline defined to be within 28 days of starting study drug.
Time Frame
Baseline, Week 104
Title
Change From Baseline in Brain Metabolism Using Fluorodeoxyglucose (FDG)
Description
Fluorodeoxyglucose (FDG) PET evaluates the regional brain metabolic rates for glucose as a sensitive, in vivo metabolic index of brain function. The outcome reported is the composite summary of the standard uptake value ratio (SUVR) normalized to the pons + vermis assessed with composite meta and composite meta automated anatomical labeling atlas (ALL). Annualized change is derived as change at LOCF divided by (LOCF date - baseline date) multiplied by 365. LS Mean was determined by ANCOVA methodology with factors for treatment, disease status at baseline, baseline biomarker and age at baseline. Baseline defined to be within 28 days of starting study drug.
Time Frame
Baseline, Week 104
Title
Change From Baseline in Whole Brain Volume
Description
Magnetic resonance imaging (MRI) was used to evaluate the effect of lanabecestat on whole brain volumes. Annualized change is derived as change at LOCF divided by (LOCF date - baseline date) multiplied by 365. LS Mean was determined by ANCOVA methodology with factors for treatment, baseline vMRI, intracranial volume, disease status at baseline and age at baseline.
Time Frame
Baseline, Week 104
Title
Pharmacokinetics (PK): Plasma Concentration of Lanabecestat
Time Frame
Week 4, post dose prior to departure from the clinic

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Gradual and progressive change in the participant's memory function over more than 6 months, reported by participant and study partner Mini-Mental State Examination score of 20-30 inclusive at screening Objective impairment in memory as evaluated by memory test performed at screening For a diagnosis of mild Alzheimer's Disease (AD), participant meets the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria for probable AD For a diagnosis of MCI due to AD, participant meets NIA-AA criteria for MCI due to AD Exclusion Criteria: Significant neurological disease affecting the central nervous system, other than AD, that may affect cognition or ability to complete the study, including but not limited to, other dementias, serious infection of the brain, Parkinson´s disease, or epilepsy or recurrent seizures History of clinically evident stroke, or multiple strokes based on history or imaging results History of clinically important carotid or vertebrobasilar stenosis or plaque History of multiple concussions with sustained cognitive complaints or objective change in neuropsychological function in the last 5 years Participants with a current Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition diagnosis of Major Depressive Disorder or any current primary psychiatric diagnosis other than AD if, in the judgment of the investigator, the psychiatric disorder or symptom is likely to confound interpretation of drug effect, affect cognitive assessments, or affect the participant´s ability to complete the study History of alcohol or drug abuse or dependence (except nicotine dependence) within 2 years before the screening Within 1 year before the screening or between screening and baseline, any of the following: myocardial infarction; moderate or severe congestive heart failure, New York Heart Association class III or IV; hospitalization for, or symptom of, unstable angina; syncope due to orthostatic hypotension or unexplained syncope; known significant structural heart disease (eg, significant valvular disease, hypertrophic cardiomyopathy), or hospitalization for arrhythmia Congenital QT prolongation History of cancer within the last 5 years, with the exception of non-metastatic basal and/or squamous cell carcinoma of the skin, in situ cervical cancer, non-progressive prostate cancer or other cancers with low-risk of recurrence or spread Current serious or unstable clinically important systemic illness that, in the judgment of the investigator, is likely to affect cognitive assessment, deteriorate, or affect the participant's safety or ability to complete the study, including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic, or hematologic disorders
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon- Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Organizational Affiliation
Eli Lilly and Company
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
St Josephs Hospital and Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Banner Sun Health Research Institute
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
Facility Name
Territory Neurology & Research Institute
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Positron Research International
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
Alliance Research Centers
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
Facility Name
Senior Clinical Trials, Inc.
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
Facility Name
Collaborative Neuroscience Network - CNS
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Pacific Research Network Inc
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
San Francisco Clinical Research Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States
Facility Name
Mile High Research Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Institute for Neurodegenerative Disorders
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Georgetown University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20057
Country
United States
Facility Name
Brain Matters Research
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33445
Country
United States
Facility Name
Direct Helpers Medical Center
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Berma Research
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Galiz Research
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
MaxBlue Institute
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33018
Country
United States
Facility Name
Alzheimer's Research and Treatment Center
City
Lake Worth
State/Province
Florida
ZIP/Postal Code
33449
Country
United States
Facility Name
Miami Jewish Health Systems
City
Miami
State/Province
Florida
ZIP/Postal Code
33137
Country
United States
Facility Name
Medical Research Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Allied Biomedical Research Institute, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Advance Medical Research Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33174
Country
United States
Facility Name
New Horizon Research Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
JDH Medical Group, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33186
Country
United States
Facility Name
Compass Research
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
IMIC, Inc.
City
Palmetto Bay
State/Province
Florida
ZIP/Postal Code
33157
Country
United States
Facility Name
Suncoast Neuroscience Associates
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33713
Country
United States
Facility Name
Roskamp Institute
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34243
Country
United States
Facility Name
Infinity Clinical Research, LLC
City
Sunrise
State/Province
Florida
ZIP/Postal Code
33351
Country
United States
Facility Name
Stedman Clinical Trials
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Olympian Clinical Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Compass Research
City
The Villages
State/Province
Florida
ZIP/Postal Code
32162
Country
United States
Facility Name
Premiere Research Institute at Palm Beach Neurology
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
The Multiple Sclerosis Center of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30327
Country
United States
Facility Name
Atlanta Center of Medical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
Country
United States
Facility Name
Carman Research
City
Smyrna
State/Province
Georgia
ZIP/Postal Code
30080
Country
United States
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Alexian Brothers Medical Center
City
Elk Grove Village
State/Province
Illinois
ZIP/Postal Code
60007
Country
United States
Facility Name
Community Clinical Research Center
City
Anderson
State/Province
Indiana
ZIP/Postal Code
46011
Country
United States
Facility Name
Indiana University School of Medicine
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
ActivMed Practices & Research, Inc
City
Methuen
State/Province
Massachusetts
ZIP/Postal Code
01844
Country
United States
Facility Name
Boston Center for Memory
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
02459
Country
United States
Facility Name
Springfield Neurology Associates
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01104
Country
United States
Facility Name
Hattiesburg Clinic
City
Hattiesburg
State/Province
Mississippi
ZIP/Postal Code
39401
Country
United States
Facility Name
Millennium Psychiatric Associates, LLV
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
St. Louis Clinical Trials, LC
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Memory Enhancement Center of America, Inc.
City
Eatontown
State/Province
New Jersey
ZIP/Postal Code
07724
Country
United States
Facility Name
AdvanceMed Research
City
Lawrenceville
State/Province
New Jersey
ZIP/Postal Code
08648
Country
United States
Facility Name
Alzheimer's Research Company
City
Manchester
State/Province
New Jersey
ZIP/Postal Code
08759
Country
United States
Facility Name
The Cognitive and Research Center of NJ
City
Springfield
State/Province
New Jersey
ZIP/Postal Code
07081
Country
United States
Facility Name
Advanced Memory Research Institute of New Jersey
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
Bio Behavioral Health
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
Neurology Specialists of Monmouth County
City
West Long Branch
State/Province
New Jersey
ZIP/Postal Code
07764
Country
United States
Facility Name
Integrative Clinical Trials, LLC
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11229
Country
United States
Facility Name
SPRI Clinical Trials, LLC.
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Facility Name
Alzheimer's Disease and Memory Disorders Center
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Facility Name
Empire Neurology, PC
City
Latham
State/Province
New York
ZIP/Postal Code
12110
Country
United States
Facility Name
Clinilabs, Inc (New York)
City
New York
State/Province
New York
ZIP/Postal Code
10019
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
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
Facility Name
Alzheimer's Memory Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28270
Country
United States
Facility Name
Valley Medical Primary Care
City
Centerville
State/Province
Ohio
ZIP/Postal Code
45459
Country
United States
Facility Name
Christ Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43221
Country
United States
Facility Name
The Corvallis Clinic P.C.
City
Corvallis
State/Province
Oregon
ZIP/Postal Code
97330
Country
United States
Facility Name
Lehigh Valley Hospital
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Rhode Island Mood & Memory Research Institute
City
East Providence
State/Province
Rhode Island
ZIP/Postal Code
02914
Country
United States
Facility Name
Roper St. Francis Healthcare
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401
Country
United States
Facility Name
Radiant Research
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
Quillen College of Medicine, East TN State University
City
Johnson City
State/Province
Tennessee
ZIP/Postal Code
37605
Country
United States
Facility Name
Senior Adults Specialty Research Inc
City
Austin
State/Province
Texas
ZIP/Postal Code
78757
Country
United States
Facility Name
Texas Health Physicians Group
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Medical Group of Texas
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
University of Texas Health Services Center - Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
University of Utah School of Medicine
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
Facility Name
The Memory Clinic
City
Bennington
State/Province
Vermont
ZIP/Postal Code
05201
Country
United States
Facility Name
Southern Neurology
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Griffith University
City
Gold Coast
State/Province
Queensland
ZIP/Postal Code
4222
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Box Hill Hospital
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Delmont Private Hospital
City
Glen Iris
State/Province
Victoria
ZIP/Postal Code
3146
Country
Australia
Facility Name
Heidelberg Repatriation Hospital
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3081
Country
Australia
Facility Name
The Florey Institute of Neuroscience and Mental Health
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
Facility Name
Australian Alzheimer's Research Foundation
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Neuro Trials Victoria Pty Ltd
City
Noble Park
ZIP/Postal Code
3174
Country
Australia
Facility Name
Jessa Ziekenhuis
City
Hasselt
State/Province
Limburg
ZIP/Postal Code
3500
Country
Belgium
Facility Name
Hopital Universitaire Brugmann Brussel
City
Brussels
ZIP/Postal Code
1020
Country
Belgium
Facility Name
Cliniques Universitaires Saint-Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Hospital Universitaire Erasme Brussel
City
Brussel
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Universitair Ziekenhuis Antwerpen
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Heilig Hartziekenhuis
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Facility Name
The Medical Arts Health Research Group
City
Kamloops
State/Province
British Columbia
ZIP/Postal Code
V2C 1K7
Country
Canada
Facility Name
Okanagan Clinical Trials
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 1Z9
Country
Canada
Facility Name
University of British Columbia
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 2B5
Country
Canada
Facility Name
Royal Jubilee Hospital
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 158
Country
Canada
Facility Name
True North Clinical Research Halifax, LLC
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3S1M7
Country
Canada
Facility Name
Bruyere Continuing Care
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1N 5C8
Country
Canada
Facility Name
Kawartha Regional Memory Clinic
City
Peterborough
State/Province
Ontario
ZIP/Postal Code
K9H2P4
Country
Canada
Facility Name
Toronto Memory Program
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3B2S7
Country
Canada
Facility Name
Toronto Western Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T2S8
Country
Canada
Facility Name
CSSS-Institut Universitaire Gériatric de Sherbrooke
City
Sherbrooke
State/Province
Qubec
ZIP/Postal Code
J1J3H5
Country
Canada
Facility Name
Clinique de la Memoire de l'Outaouais
City
Gatineau
State/Province
Quebec
ZIP/Postal Code
J8T 8J1
Country
Canada
Facility Name
NeuroSearch Developements
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2J2
Country
Canada
Facility Name
Hopital Maisonneure-Rosemount
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Hopital de L'Enfant Jesus
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1J 1Z4
Country
Canada
Facility Name
Q&T Research Sherbrooke Inc
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1J 2G2
Country
Canada
Facility Name
CHU de Toulouse Hopital Purpan
City
Toulouse
State/Province
Cedex 9
ZIP/Postal Code
31059
Country
France
Facility Name
Hopital Neuro Pierre Wertheimer
City
Bron Cedex
ZIP/Postal Code
69677
Country
France
Facility Name
CHU Dijonon
City
Dijon Cedex
ZIP/Postal Code
21033
Country
France
Facility Name
CHRU Lille - Hopital Roger Salengro
City
Lille Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
CHU Hopital de la Timone
City
Marseille Cedex 05
ZIP/Postal Code
13385
Country
France
Facility Name
Chu de Nantes Hopital Laennec
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Hopital Broca
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Hopital de la Pitie Salpetriere
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Hopital Lariboisière
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
CHU de Toulouse
City
Toulouse
ZIP/Postal Code
31052
Country
France
Facility Name
Hopital des Charpennes
City
Villeurbanne
ZIP/Postal Code
69100
Country
France
Facility Name
Universitätsklinikum Tübingen
City
Tübingen
State/Province
Baden-Württemberg
ZIP/Postal Code
72076
Country
Germany
Facility Name
Universitätsklinikum Ulm
City
Ulm
State/Province
Baden-Württemberg
ZIP/Postal Code
89081
Country
Germany
Facility Name
Studien und Gedächtniszentrum München
City
München
State/Province
Bayern
ZIP/Postal Code
80331
Country
Germany
Facility Name
Klinikum Rechts der Isar der TU München
City
München
State/Province
Bayern
ZIP/Postal Code
81675
Country
Germany
Facility Name
Institut fur Psychogerontologie
City
Nürnberg
State/Province
Bayern
ZIP/Postal Code
90402
Country
Germany
Facility Name
Neurozentrum Prien
City
Prien am Chiemsee
State/Province
Bayern
ZIP/Postal Code
83209
Country
Germany
Facility Name
Institut für Neuropsychiatrie INP3
City
Wenzenbach
State/Province
Bayern
ZIP/Postal Code
93173
Country
Germany
Facility Name
Studienzentrum Nord-West
City
Westerstede
State/Province
Niedersachsen
ZIP/Postal Code
26655
Country
Germany
Facility Name
Praxis Dr. Lauter
City
Bochum
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
44787
Country
Germany
Facility Name
St Josef-Hospital Bochum
City
Bochum
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
44791
Country
Germany
Facility Name
Universitätsklinikum Bonn
City
Bonn
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
53105
Country
Germany
Facility Name
Gemeinschaftspraxis für Neurologie Prof. Gereon Nelles
City
Köln
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
50935
Country
Germany
Facility Name
Universitätsklinikum Köln
City
Köln
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
50937
Country
Germany
Facility Name
Neurologische Praxis Siegen
City
Siegen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
57076
Country
Germany
Facility Name
Universitätsklinikum des Saarlandes
City
Homburg
State/Province
Saarland
ZIP/Postal Code
66421
Country
Germany
Facility Name
Martin-Luther-Universität Halle-Wittenberg
City
Halle (Saale)
State/Province
Sachsen-Anhalt
ZIP/Postal Code
06097
Country
Germany
Facility Name
Universitätsklinikum Otto-von-Guericke-Universität
City
Magdeburg
State/Province
Sachsen-Anhalt
ZIP/Postal Code
39120
Country
Germany
Facility Name
Pharmakologisches Studienzentrum Chemnitz
City
Mittweida
State/Province
Sachsen
ZIP/Postal Code
09648
Country
Germany
Facility Name
Arztpraxis Dr. Christian Oehlwein
City
Gera
State/Province
Thüringen
ZIP/Postal Code
07551
Country
Germany
Facility Name
Gemeinschaftspraxis Dr. R. Ehret & Dr. W. von Pannwitz
City
Berlin
ZIP/Postal Code
12163
Country
Germany
Facility Name
Charité Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Facility Name
Charité Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
PTE KK Pszichiatriai es Pszichoterapias Klinika
City
Pecs
State/Province
Baranya
ZIP/Postal Code
7623
Country
Hungary
Facility Name
Semmelweis Medical University
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Del-pesti Centrumkorház - Orszagos Hematologiai és Infektologiai Intezet
City
Budapest
ZIP/Postal Code
1097
Country
Hungary
Facility Name
Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz
City
Debrecen
ZIP/Postal Code
4031
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Kozpont
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Univerisity of Szeged
City
Szeged
ZIP/Postal Code
6725
Country
Hungary
Facility Name
Ospedale Degli Infermi ASR USSL 12
City
Ponderano
State/Province
Biella
ZIP/Postal Code
13875
Country
Italy
Facility Name
Azienda Ospedaliera San Gerardo
City
Monza
State/Province
Milano
ZIP/Postal Code
20900
Country
Italy
Facility Name
Fondazione San Raffaele Giglio di Cefalu
City
Cefalu
State/Province
Palermo
ZIP/Postal Code
90015
Country
Italy
Facility Name
Universita Di Pisa
City
Pisa
State/Province
PI
ZIP/Postal Code
56126
Country
Italy
Facility Name
Università Politecnica delle Marche Torrette
City
Ancona
ZIP/Postal Code
60126
Country
Italy
Facility Name
IRCCS San Giovanni di Dio Fatebenefratelli
City
Brescia
ZIP/Postal Code
25125
Country
Italy
Facility Name
Fondazione Universitaria degli Studi G D'Annunzio
City
Chieti
ZIP/Postal Code
66100
Country
Italy
Facility Name
Ente Ospedaliero Ospedali Galliera
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Fondazione IRCCS Ca'Granda Ospedale Maggiore Policinico
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
Nuovo Ospedale Civile Sant'Agostino Estense
City
Modena
ZIP/Postal Code
41010
Country
Italy
Facility Name
Policlinico Univ. Agostino Gemelli
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Dip.to Med. Sperimentale -Polic.Umberto I -Univ. La Sapienza
City
Roma
ZIP/Postal Code
00185
Country
Italy
Facility Name
Ospedale San Giovanni Calibita Fatebenefratelli
City
Roma
ZIP/Postal Code
00186
Country
Italy
Facility Name
Policlinico Ospedale S. Andrea
City
Roma
ZIP/Postal Code
00189
Country
Italy
Facility Name
Azienda Ospedaliera Citta della Salute della Scienza Torino
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
National Institute for Longevity Sciences NCGG
City
Obu
State/Province
Aichi
ZIP/Postal Code
474-0038
Country
Japan
Facility Name
National Chiba-East-Hospital
City
Chuo-ku
State/Province
Chiba
ZIP/Postal Code
260-8712
Country
Japan
Facility Name
National Hospital Organization Asahikawa Medical Center
City
Asahikawa
State/Province
Hokkaido
ZIP/Postal Code
070-8644
Country
Japan
Facility Name
Tsukuba University Hospital
City
Tsukuba
State/Province
Ibaraki
ZIP/Postal Code
305-8576
Country
Japan
Facility Name
Iwate Medical University Hospital
City
Morioka
State/Province
Iwate
ZIP/Postal Code
020-8505
Country
Japan
Facility Name
Shonan Kamakura General Hospital
City
Kamakura
State/Province
Kanagawa
ZIP/Postal Code
247-8533
Country
Japan
Facility Name
Nihon Kokan Hospital
City
Kawasaki
State/Province
Kanagawa
ZIP/Postal Code
210-0852
Country
Japan
Facility Name
Yokohama City University Hospital
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
236-0004
Country
Japan
Facility Name
Kyoto Prefectural University of Medicine
City
Kyoto-shi
State/Province
Kyoto
ZIP/Postal Code
602-8566
Country
Japan
Facility Name
Rakuwakai Otowarehabilitation Hospital
City
Kyoto-shi
State/Province
Kyoto
ZIP/Postal Code
607-8113
Country
Japan
Facility Name
Ina Central Hospital
City
Ina
State/Province
Nagano
ZIP/Postal Code
396-8555
Country
Japan
Facility Name
Matsumoto Medical Center
City
Matsumoto
State/Province
Nagano
ZIP/Postal Code
399-0021
Country
Japan
Facility Name
Katayama Medical Clinic
City
Kurashiki
State/Province
Okayama
ZIP/Postal Code
701-0192
Country
Japan
Facility Name
Shiroma Clinic
City
Urasoe
State/Province
Okinawa
ZIP/Postal Code
901-2102
Country
Japan
Facility Name
Koshokai aino hospital
City
Ibaraki
State/Province
Osaka
ZIP/Postal Code
567-0011
Country
Japan
Facility Name
Sakaguchi Clinic
City
Sakai
State/Province
Osaka
ZIP/Postal Code
593-8301
Country
Japan
Facility Name
National Sanatorium Toneyama Hospital
City
Toyonaka
State/Province
Osaka
ZIP/Postal Code
560-8552
Country
Japan
Facility Name
Saitama Medical University Hospital
City
Iruma-Gun
State/Province
Saitama
ZIP/Postal Code
350-0495
Country
Japan
Facility Name
Nippon Medical School Hospital
City
Bunkyo-Ku
State/Province
Tokyo
ZIP/Postal Code
113-8603
Country
Japan
Facility Name
The University of Tokyo Hospital
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8655
Country
Japan
Facility Name
Nozomi Memory Clinic
City
Mitaka-shi
State/Province
Tokyo
ZIP/Postal Code
181-0013
Country
Japan
Facility Name
Sangenjaya Nakamura Mental Clinic
City
Setagaya
State/Province
Tokyo
ZIP/Postal Code
154-0004
Country
Japan
Facility Name
Kanauchi Medical Clinic
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-0023
Country
Japan
Facility Name
Tokyo Women's Medical University Hospital
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
162-8666
Country
Japan
Facility Name
Memory Clinic Ochanomizu
City
Tsukuba
State/Province
Tokyo
ZIP/Postal Code
305 8576
Country
Japan
Facility Name
National Sanatorium Hokuriku Hospital
City
Nanto
State/Province
Toyama
ZIP/Postal Code
939-1893
Country
Japan
Facility Name
Fukuoka University Hospital
City
Fukuoka
ZIP/Postal Code
814-0180
Country
Japan
Facility Name
Kyoto University Hospital
City
Kyoto
ZIP/Postal Code
606-8507
Country
Japan
Facility Name
Kyoto Minami Hospital
City
Kyoto
ZIP/Postal Code
610-0113
Country
Japan
Facility Name
Utano Hospital
City
Kyoto
ZIP/Postal Code
616-8255
Country
Japan
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Osaka
ZIP/Postal Code
545-8586
Country
Japan
Facility Name
Dong-A University Medical Center
City
Seogu
State/Province
Busan
ZIP/Postal Code
49201
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Geonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
The Catholic University of Korea-Bucheon St. Mary's Hospital
City
Bucheon-si
State/Province
Gyeonggi-do
ZIP/Postal Code
14647
Country
Korea, Republic of
Facility Name
Hanyang University Guri Hospital
City
Guri-si
State/Province
Gyeonggido
ZIP/Postal Code
11923
Country
Korea, Republic of
Facility Name
Gachon University Gil Medical Center
City
Namdong
State/Province
Incheon
ZIP/Postal Code
21565
Country
Korea, Republic of
Facility Name
Inha University Hospital
City
Incheon
ZIP/Postal Code
22332
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
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
NZOZ Wroclawskie Centrum Alzheimerowskie
City
Wroclaw
State/Province
Dolnoslaskie
ZIP/Postal Code
53 139
Country
Poland
Facility Name
Medycyna Milorzab
City
Lodz
State/Province
Lódzkie
ZIP/Postal Code
92216
Country
Poland
Facility Name
Podlaskie Centrum Psychogeriatrii
City
Białystok
State/Province
Podlaskie
ZIP/Postal Code
15-732
Country
Poland
Facility Name
NZOZ Dom Sue Ryder - Pallmed Sp. z o.o.
City
Bydgoszcz
ZIP/Postal Code
85-796
Country
Poland
Facility Name
NZOZ Wielospecjalistyczna Poradnia Lekarska
City
Katowice
ZIP/Postal Code
40-123
Country
Poland
Facility Name
Specjalistyczna Praktyka Lekarska prof. Grzegorz Opala
City
Katowice
ZIP/Postal Code
40-588
Country
Poland
Facility Name
Centrum Zdrowia Psychicznego
City
Kielce
ZIP/Postal Code
25411
Country
Poland
Facility Name
Centrum Neurologii Klinicznej
City
Krakow
ZIP/Postal Code
31-505
Country
Poland
Facility Name
NZOZ Neuromed M. I M. Nastaj sp. P.
City
Lublin
ZIP/Postal Code
20-064
Country
Poland
Facility Name
Instytut Medycyny Wsi
City
Lublin
ZIP/Postal Code
20-090
Country
Poland
Facility Name
NEURO-CARE Sp. z o.o. Sp. Komandytowa
City
Siemianowice Śląskie
ZIP/Postal Code
41-100
Country
Poland
Facility Name
Centrum Medyczne
City
Warszawa
ZIP/Postal Code
01-697
Country
Poland
Facility Name
Centralny Szpital Kliniczny MSW
City
Warszawa
ZIP/Postal Code
02-507
Country
Poland
Facility Name
Santa Cruz Behavioral PSC
City
Bayamon
ZIP/Postal Code
00961
Country
Puerto Rico
Facility Name
Ivonne Z. Jimenez-Velazquez, MD
City
Carolina
ZIP/Postal Code
00984
Country
Puerto Rico
Facility Name
Instituto de Neurologia Dra. Ivonne Fraga
City
San Juan
ZIP/Postal Code
00918
Country
Puerto Rico
Facility Name
Michel A. Woodbury-Farina, MD.
City
San Juan
ZIP/Postal Code
00918
Country
Puerto Rico
Facility Name
SC Med Life SA
City
Bucuresti
ZIP/Postal Code
010719
Country
Romania
Facility Name
SC Centrul Medical Sana SRL
City
Bucuresti
ZIP/Postal Code
011025
Country
Romania
Facility Name
Policlinica CCBR S.R.L.
City
Bucuresti
ZIP/Postal Code
30463
Country
Romania
Facility Name
SC Med Life SA
City
Timisoara
ZIP/Postal Code
300166
Country
Romania
Facility Name
Hospital General Universitario de Elche
City
Elche
State/Province
Alicante
ZIP/Postal Code
03203
Country
Spain
Facility Name
Hospital General de Catalunya
City
Sant Cugat del Valles
State/Province
Barcelona
ZIP/Postal Code
08190
Country
Spain
Facility Name
Hospital Virgen Del Puerto
City
Plasencia
State/Province
Caceres
ZIP/Postal Code
10600
Country
Spain
Facility Name
Hospital Universitario De Getafe
City
Madrid
State/Province
Getafe
ZIP/Postal Code
28905
Country
Spain
Facility Name
Hospital Puerta De Hierro
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Centro de Atencion Especializada (CAE) OROITU
City
Getxo
State/Province
Vizcaya
ZIP/Postal Code
48993
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital Santa Creu I Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Fundacion ACE-Institut Catala de Neurociences Aplicades
City
Barcelona
ZIP/Postal Code
08028
Country
Spain
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Universitari de Bellvitge
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital Reina Sofia
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Hospital De La Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital Universitario Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Son Espases
City
Palma de Mallorca
ZIP/Postal Code
07010
Country
Spain
Facility Name
Hospital Univ Sant Joan de Reus, S.A.
City
Reus
ZIP/Postal Code
43204
Country
Spain
Facility Name
Fundacion CITA Alzheimer
City
San Sebastian
ZIP/Postal Code
20009
Country
Spain
Facility Name
Hospital Doctor Peset
City
Valencia
ZIP/Postal Code
46017
Country
Spain
Facility Name
Hospital Universitario La Fe de Valencia
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Plymouth Hospitals NHS Trust
City
Plymouth
State/Province
Devon
ZIP/Postal Code
PL6 8BX
Country
United Kingdom
Facility Name
Cognitive Treatment & Research Unit
City
Crowborough
State/Province
East Sussex
ZIP/Postal Code
TN6 1HB
Country
United Kingdom
Facility Name
Southern Health NHS
City
Southampton
State/Province
Hampshire
ZIP/Postal Code
SO30 3JB
Country
United Kingdom
Facility Name
MAC UK Neuroscience Ltd
City
Blackpool
State/Province
Lancs
ZIP/Postal Code
FY20JH
Country
United Kingdom
Facility Name
MAC Clinical Research
City
Stourton
State/Province
Leeds
ZIP/Postal Code
LS10 1DU
Country
United Kingdom
Facility Name
MAC Clinical Research
City
Cannock
State/Province
Staffordshire
ZIP/Postal Code
WS11 0BN
Country
United Kingdom
Facility Name
West London Mental Health NHS Trust
City
Brentford
ZIP/Postal Code
TW8 8DS
Country
United Kingdom
Facility Name
Glasgow Memory Clinic
City
Glasgow
ZIP/Postal Code
G20 0XA
Country
United Kingdom
Facility Name
Hammersmith Hospital
City
London
ZIP/Postal Code
W12 0NN
Country
United Kingdom
Facility Name
Guildford Nuffield Hospital
City
London
ZIP/Postal Code
W1G 9JF
Country
United Kingdom
Facility Name
Re-Cognition Health Ltd
City
London
ZIP/Postal Code
W1G 9RU
Country
United Kingdom
Facility Name
MAC Clinical Research
City
Manchester
ZIP/Postal Code
M13 9NQ
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD Sharing Time Frame
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
IPD Sharing Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD Sharing URL
https://www.clinicalstudydatarequest.com/
Citations:
PubMed Identifier
33049114
Citation
Wessels AM, Lines C, Stern RA, Kost J, Voss T, Mozley LH, Furtek C, Mukai Y, Aisen PS, Cummings JL, Tariot PN, Vellas B, Dupre N, Randolph C, Michelson D, Andersen SW, Shering C, Sims JR, Egan MF. Cognitive outcomes in trials of two BACE inhibitors in Alzheimer's disease. Alzheimers Dement. 2020 Nov;16(11):1483-1492. doi: 10.1002/alz.12164. Epub 2020 Oct 13.
Results Reference
derived
PubMed Identifier
31764959
Citation
Wessels AM, Tariot PN, Zimmer JA, Selzler KJ, Bragg SM, Andersen SW, Landry J, Krull JH, Downing AM, Willis BA, Shcherbinin S, Mullen J, Barker P, Schumi J, Shering C, Matthews BR, Stern RA, Vellas B, Cohen S, MacSweeney E, Boada M, Sims JR. Efficacy and Safety of Lanabecestat for Treatment of Early and Mild Alzheimer Disease: The AMARANTH and DAYBREAK-ALZ Randomized Clinical Trials. JAMA Neurol. 2020 Feb 1;77(2):199-209. doi: 10.1001/jamaneurol.2019.3988. Erratum In: JAMA Neurol. 2020 Sep 1;77(9):1179.
Results Reference
derived
PubMed Identifier
27767991
Citation
Cebers G, Alexander RC, Haeberlein SB, Han D, Goldwater R, Ereshefsky L, Olsson T, Ye N, Rosen L, Russell M, Maltby J, Eketjall S, Kugler AR. AZD3293: Pharmacokinetic and Pharmacodynamic Effects in Healthy Subjects and Patients with Alzheimer's Disease. J Alzheimers Dis. 2017;55(3):1039-1053. doi: 10.3233/JAD-160701.
Results Reference
derived
Links:
URL
https://www.lillytrialguide.com/en-US/studies/mild-alzheimer-s-disease/AZES#?postal=
Description
Click here for more information about this study: An Efficacy and Safety Study of LY3314814 in Early Alzheimer's Disease
URL
https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=16023&attachmentIdentifier=f8802097-b8c3-4396-ad08-8df8ca98325d&fileName=CSP_NCT02245737.pdf&versionIdentifier=
Description
CSP
URL
https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=16023&attachmentIdentifier=5c8b319d-5e9f-4b1d-b366-d589b53774a8&fileName=SAP_NCT02245737.pdf&versionIdentifier=
Description
SAP

Learn more about this trial

An Efficacy and Safety Study of Lanabecestat (LY3314814) in Early Alzheimer's Disease

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