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A Study of Lanabecestat (LY3314814) in Early Alzheimer's Disease Dementia

Primary Purpose

Alzheimer's Disease

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Lanabecestat
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, Neurodegenerative Diseases, Central Nervous System Diseases, Nervous System Diseases, Mental Disorders, Delirium, Dementia, Amnestic, Cognitive Disorders, Tauopathies, Memory, Amyloid

Eligibility Criteria

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

Inclusion Criteria:

  • Participants previously enrolled in AMARANTH (NCT02245737) who meet eligibility criteria for delayed-start I8D-MC-AZFD.

Exclusion Criteria:

  • Participants who participate in AMARANTH (NCT02245737) who develop new conditions precluding them from enrolling into I8D-MC-AZFD.

Sites / Locations

  • Banner Alzheimer's Institute
  • Territory Neurology & Research Institute
  • Pacific Research Network Inc
  • Mile High Research Center
  • Institute for Neurodegenerative Disorders
  • Georgetown University Medical Center
  • Brain Matters Research
  • Compass Research
  • IMIC, Inc.
  • Suncoast Neuroscience Associates
  • Roskamp Institute
  • Premiere Research Institute at Palm Beach Neurology
  • The Multiple Sclerosis Center of Atlanta
  • University of Chicago Medical Center
  • Community Clinical Research Center
  • Boston Center for Memory
  • Hattiesburg Clinic
  • Memory Enhancement Center of America, Inc.
  • The Cognitive and Research Center of NJ
  • Advanced Memory Research Institute of New Jersey
  • Integrative Clinical Trials, LLC
  • Columbia University Medical Center
  • University of Rochester School of Medicine
  • Valley Medical Primary Care
  • Lindner Research Center
  • Ohio State University Medical Center
  • Lehigh Valley Hospital
  • Rhode Island Mood & Memory Research Institute
  • Radiant Research
  • Quillen College of Medicine, East TN State University
  • The Memory Clinic
  • Southern Neurology
  • Royal Adelaide Hospital
  • Eastern Clinical Research Unit
  • Delmont Private 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
  • Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
  • AZ Delta
  • Okanagan Clinical Trials
  • True North Clinical Research Halifax, LLC
  • Elizabeth Bruyere Health Centre
  • Kawartha Regional Memory Clinic
  • Toronto Memory Program
  • Clinique de la Memoire de l'Outaouais
  • NeuroSearch Developements
  • Hopital de L'Enfant Jesus
  • Q&T Research Sherbrooke Inc
  • Centre Hospitalier Universitaire La Timone
  • CHRU de Lille- Hôpital Roger Salengro
  • CHU de Toulouse Hopital Purpan
  • Hopital Neuro Pierre Wertheimer
  • CHU Bocage CMRR
  • Hopital Broca
  • Hôpital de la Pitié-Salpêtrière
  • Hôpital Fernand Widal
  • Chu de Nantes Hopital Laennec
  • Centre de Recherche Clinique du Gérontopôle Cité de la Santé
  • Hopital des Charpennes
  • Universitätsklinikum Ulm
  • Studien und Gedächtniszentrum München
  • Klinikum Rechts der Isar der TU München
  • Gemeinschaftspraxis für Neurologie und Psychiatrie
  • DataMed Klinische Studien GmbH
  • Universitätsklinikum Köln
  • Neurologische Praxis Siegen
  • Pharm Studienzentrum Chemnitz
  • Charité Universitätsmedizin Berlin
  • Charité Universitätsmedizin Berlin
  • SE Neurologiai Klinika
  • National Institute for Longevity Sciences NCGG
  • National Chiba-East-Hospital
  • Tsukuba University Hospital
  • Iwate Medical University Hospital
  • Nihon Kokan Hospital
  • Katayama Medical Clinic
  • Shiroma Clinic
  • Sakaguchi Clinic
  • National Sanatorium Toneyama Hospital
  • Memory Clinic Ochanomizu
  • Nippon Medical School Hospital
  • The University of Tokyo Hospital
  • Tokyo Women's Medical University Hospital
  • National Sanatorium Hokuriku Hospital
  • Fukuoka University Hospital
  • Kyoto University Hospital
  • Utano Hospital
  • Osaka City University Hospital
  • Dong-A University Medical Center
  • Hanyang University Guri Hospital
  • Inha University Hospital
  • Samsung Medical Center
  • Gachon University Gil Medical Center
  • Asan Medical Center
  • Seoul St. Mary's Hospital
  • Podlaskie Centrum Psychogeriatrii
  • NZOZ Dom Sue Ryder - Pallmed Sp. z o.o.
  • NZOZ Wielospecjalistyczna Poradnia Lekarska
  • Centrum Zdrowia Psychicznego Biomed - Jan Latala
  • Krakowska Akademia Neurologii
  • Medycyna Milorzab
  • Instytut Medycyny Wsi
  • Centrum Medyczne Neuroprotect
  • Santa Cruz Behavioral PSC
  • SC Med Life SA
  • SC Centrul Medical Sana SRL
  • Hospital General Universitario de Elche
  • Hospital Universitari de Bellvitge
  • Hospital Virgen Del Puerto
  • Hospital Universitario De Getafe
  • CITA Alzheimer
  • Centro de Atencion Especializada (CAE) OROITU
  • Fundacion ACE-Institut Catala de Neurociences Aplicades
  • Hospital Santa Creu I Sant Pau
  • Hospital Clinic I Provincial
  • Hospital De La Princesa
  • Hospital Universitario Ramon y Cajal
  • Hospital Son Espases
  • Hospital Universitario Dr Pesset
  • Hospital Universitario La Fe de Valencia
  • Re-Cognition Health Ltd
  • MAC Clinical Research-Manchester
  • MAC Clinical Research
  • West London Mental Health NHS Trust
  • MAC Clinical Research
  • Re-Cognition Health Ltd
  • Glasgow Memory Clinic
  • MAC Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

AZES Lanabecestat 20 milligrams (mg)/AZFD Lanabecestat 20 mg

AZES Lanabecestat 50 mg/AZFD Lanabecestat 50 mg

AZES Placebo/AZFD Lanabecestat 20 mg

AZES Placebo/AZFD Lanabecestat 50 mg

Arm Description

Participants who received Lanabecestat 20 mg in the feeder study (AZES) were randomized to receive Lanabecestat 20 mg.

Participants who received Lanabecestat 50 mg in the feeder study (AZES) were randomized to receive Lanabecestat 50 mg.

Participants who received placebo in the feeder study (AZES) were randomized to receive Lanabecestat 20 mg.

Participants who received placebo in the feeder study (AZES) were randomized to receive Lanabecestat 50 mg.

Outcomes

Primary Outcome Measures

Change From Baseline Analysis 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*visit, baseline efficacy score, baseline efficacy score-by-visit interaction, disease status at baseline, apolipoprotein E4 (APOE4) status, acetylcholinesterase inhibitor (AChEI) use at baseline, age at baseline, and pooled country.

Secondary Outcome Measures

Change From Baseline Analysis 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 with factors for treatment, visit, treatment*visit, baseline efficacy score, baseline efficacy score-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, age at baseline, and pooled country.
Change From Baseline on the Functional Activities Questionnaire (FAQ) Score
FAQ is a 10-item, caregiver-questionnaire and was administered to the study partner and 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 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 determined by MMRM with factors for treatment, visit, treatment*visit, baseline efficacy score, baseline efficacy score-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, age 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 with factors for treatment, visit, treatment*visit, baseline efficacy score, baseline efficacy score-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, age at baseline, and pooled country.
Change From Baseline on the Mini-Mental Status Examination (MMSE)
The MMSE is an instrument used to assess a participant's 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*visit, baseline efficacy score, baseline efficacy score-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, age at baseline, and pooled country.
Change From Baseline Analysis on the ADAS-Cog13
ADAS-cog13 (13-item 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*visit, baseline efficacy score, baseline efficacy score-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, age at baseline, and pooled country.

Full Information

First Posted
November 21, 2016
Last Updated
November 19, 2019
Sponsor
AstraZeneca
Collaborators
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT02972658
Brief Title
A Study of Lanabecestat (LY3314814) in Early Alzheimer's Disease Dementia
Official Title
A Randomized, Double-Blind, Delayed-Start Study of LY3314814 (AZD3293) in Early Alzheimer's Disease Dementia (Extension of Study AZES, The AMARANTH Study)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Terminated
Why Stopped
As the feeder study (AZES) was stopped for futility after an independent assessment, this trial was also stopped.
Study Start Date
March 15, 2017 (Actual)
Primary Completion Date
October 2, 2018 (Actual)
Study Completion Date
October 2, 2018 (Actual)

3. Sponsor/Collaborators

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

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 study is an extension of study I8D-MC-AZES (NCT02245737), the AMARANTH study. The purpose of this study is to evaluate the effectiveness of the study drug lanabecestat in participants with early Alzheimer's disease dementia at the time of entry into study I8D-MC-AZES.
Detailed Description
Study AZFD was designed to be integrated with 104-week study AZES to form a Delayed-Start study (Study AZES-FD). Study AZES-FD was to be used to test the hypothesis that participants originally randomized to receive placebo in the double-blind feeder study AZES and switched to LY3314814 at the start of study AZFD did not "catch up" on the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog13) at Week 26 of study AZFD to participants originally randomized to receive LY3314814 in the double-blind feeder study.

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, Neurodegenerative Diseases, Central Nervous System Diseases, Nervous System Diseases, Mental Disorders, Delirium, Dementia, Amnestic, Cognitive Disorders, Tauopathies, Memory, Amyloid

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
AZES Lanabecestat 20 milligrams (mg)/AZFD Lanabecestat 20 mg
Arm Type
Experimental
Arm Description
Participants who received Lanabecestat 20 mg in the feeder study (AZES) were randomized to receive Lanabecestat 20 mg.
Arm Title
AZES Lanabecestat 50 mg/AZFD Lanabecestat 50 mg
Arm Type
Experimental
Arm Description
Participants who received Lanabecestat 50 mg in the feeder study (AZES) were randomized to receive Lanabecestat 50 mg.
Arm Title
AZES Placebo/AZFD Lanabecestat 20 mg
Arm Type
Experimental
Arm Description
Participants who received placebo in the feeder study (AZES) were randomized to receive Lanabecestat 20 mg.
Arm Title
AZES Placebo/AZFD Lanabecestat 50 mg
Arm Type
Experimental
Arm Description
Participants who received placebo in the feeder study (AZES) were randomized to receive Lanabecestat 50 mg.
Intervention Type
Drug
Intervention Name(s)
Lanabecestat
Other Intervention Name(s)
LY3314814, AZD3293
Intervention Description
Administered orally
Primary Outcome Measure Information:
Title
Change From Baseline Analysis 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*visit, baseline efficacy score, baseline efficacy score-by-visit interaction, disease status at baseline, apolipoprotein E4 (APOE4) status, acetylcholinesterase inhibitor (AChEI) use at baseline, age at baseline, and pooled country.
Time Frame
AZES Baseline through AZFD Week 26
Secondary Outcome Measure Information:
Title
Change From Baseline Analysis 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 with factors for treatment, visit, treatment*visit, baseline efficacy score, baseline efficacy score-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, age at baseline, and pooled country.
Time Frame
AZES Baseline through AZFD Week 26
Title
Change From Baseline on the Functional Activities Questionnaire (FAQ) Score
Description
FAQ is a 10-item, caregiver-questionnaire and was administered to the study partner and 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 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 determined by MMRM with factors for treatment, visit, treatment*visit, baseline efficacy score, baseline efficacy score-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, age at baseline, and pooled country.
Time Frame
AZES Baseline through AZFD Week 26
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 with factors for treatment, visit, treatment*visit, baseline efficacy score, baseline efficacy score-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, age at baseline, and pooled country.
Time Frame
AZES Baseline through AZFD Week 26
Title
Change From Baseline on the Mini-Mental Status Examination (MMSE)
Description
The MMSE is an instrument used to assess a participant's 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*visit, baseline efficacy score, baseline efficacy score-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, age at baseline, and pooled country.
Time Frame
AZES Baseline through AZFD Week 26
Title
Change From Baseline Analysis on the ADAS-Cog13
Description
ADAS-cog13 (13-item 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*visit, baseline efficacy score, baseline efficacy score-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, age at baseline, and pooled country.
Time Frame
AZES Baseline through AZFD Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants previously enrolled in AMARANTH (NCT02245737) who meet eligibility criteria for delayed-start I8D-MC-AZFD. Exclusion Criteria: Participants who participate in AMARANTH (NCT02245737) who develop new conditions precluding them from enrolling into I8D-MC-AZFD.
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
Territory Neurology & Research Institute
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Pacific Research Network Inc
City
San Diego
State/Province
California
ZIP/Postal Code
92103
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
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
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
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Community Clinical Research Center
City
Anderson
State/Province
Indiana
ZIP/Postal Code
46011
Country
United States
Facility Name
Boston Center for Memory
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
02459
Country
United States
Facility Name
Hattiesburg Clinic
City
Hattiesburg
State/Province
Mississippi
ZIP/Postal Code
39401
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
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
Integrative Clinical Trials, LLC
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11229
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 School of Medicine
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
Facility Name
Valley Medical Primary Care
City
Centerville
State/Province
Ohio
ZIP/Postal Code
45459
Country
United States
Facility Name
Lindner Research Center
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
43210
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
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
37604
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
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Eastern Clinical Research Unit
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
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
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
AZ Delta
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Facility Name
Okanagan Clinical Trials
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 1Z9
Country
Canada
Facility Name
True North Clinical Research Halifax, LLC
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3S1M7
Country
Canada
Facility Name
Elizabeth Bruyere Health Centre
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
KIN 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
M3B 2S7
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 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
Centre Hospitalier Universitaire La Timone
City
Marseille
State/Province
Cedex 05
ZIP/Postal Code
13385
Country
France
Facility Name
CHRU de Lille- Hôpital Roger Salengro
City
Lille
State/Province
Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
CHU de Toulouse Hopital Purpan
City
Toulouse
State/Province
Cedex
ZIP/Postal Code
31059
Country
France
Facility Name
Hopital Neuro Pierre Wertheimer
City
Bron Cedex
ZIP/Postal Code
69677
Country
France
Facility Name
CHU Bocage CMRR
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Hopital Broca
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Hôpital de la Pitié-Salpêtrière
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Hôpital Fernand Widal
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
Chu de Nantes Hopital Laennec
City
Saint-Herblain
ZIP/Postal Code
44093
Country
France
Facility Name
Centre de Recherche Clinique du Gérontopôle Cité de la Santé
City
Toulouse
ZIP/Postal Code
31052
Country
France
Facility Name
Hopital des Charpennes
City
Villeurbanne
ZIP/Postal Code
69100
Country
France
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
Gemeinschaftspraxis für Neurologie und Psychiatrie
City
Westerstede
State/Province
Niedersachsen
ZIP/Postal Code
26655
Country
Germany
Facility Name
DataMed Klinische Studien GmbH
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
Pharm Studienzentrum Chemnitz
City
Mittweida
State/Province
Sachsen
ZIP/Postal Code
09648
Country
Germany
Facility Name
Charité Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Charité Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Facility Name
SE Neurologiai Klinika
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
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
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
Nihon Kokan Hospital
City
Kawasaki
State/Province
Kanagawa
ZIP/Postal Code
210-0852
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
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
Memory Clinic Ochanomizu
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-0034
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
Tokyo Women's Medical University Hospital
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
162-8666
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
Utano Hospital
City
Kyoto
ZIP/Postal Code
616-8255
Country
Japan
Facility Name
Osaka City University Hospital
City
Osaka
ZIP/Postal Code
637086
Country
Japan
Facility Name
Dong-A University Medical Center
City
Seogu
State/Province
Busan
ZIP/Postal Code
49201
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
Inha University Hospital
City
Junggu
State/Province
Incheon
ZIP/Postal Code
22332
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
State/Province
Korea
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Gachon University Gil Medical Center
City
Incheon
ZIP/Postal Code
21565
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Seoul St. Mary's Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
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
Centrum Zdrowia Psychicznego Biomed - Jan Latala
City
Kielce
ZIP/Postal Code
25-411
Country
Poland
Facility Name
Krakowska Akademia Neurologii
City
Krakow
ZIP/Postal Code
31-505
Country
Poland
Facility Name
Medycyna Milorzab
City
Lodz
ZIP/Postal Code
93-118
Country
Poland
Facility Name
Instytut Medycyny Wsi
City
Lublin
ZIP/Postal Code
20-950
Country
Poland
Facility Name
Centrum Medyczne Neuroprotect
City
Warszawa
ZIP/Postal Code
01-697
Country
Poland
Facility Name
Santa Cruz Behavioral PSC
City
Bayamón
ZIP/Postal Code
00961-6911
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
Hospital General Universitario de Elche
City
Elche
State/Province
Alicante
ZIP/Postal Code
03203
Country
Spain
Facility Name
Hospital Universitari de Bellvitge
City
Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
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
CITA Alzheimer
City
San Sebastian
State/Province
Guipuzcoa
ZIP/Postal Code
20009
Country
Spain
Facility Name
Centro de Atencion Especializada (CAE) OROITU
City
Getxo
State/Province
Vizcaya
ZIP/Postal Code
48993
Country
Spain
Facility Name
Fundacion ACE-Institut Catala de Neurociences Aplicades
City
Barcelona
ZIP/Postal Code
08014
Country
Spain
Facility Name
Hospital Santa Creu I Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital Clinic I Provincial
City
Barcelona
ZIP/Postal Code
08036
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 Universitario Dr Pesset
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
Re-Cognition Health Ltd
City
London
State/Province
Greater London
ZIP/Postal Code
W1G 9JF
Country
United Kingdom
Facility Name
MAC Clinical Research-Manchester
City
Manchester
State/Province
Greater Manchester
ZIP/Postal Code
M13 9NQ
Country
United Kingdom
Facility Name
MAC Clinical Research
City
Blackpool
State/Province
Lancashire
ZIP/Postal Code
FY2 0JH
Country
United Kingdom
Facility Name
West London Mental Health NHS Trust
City
Isleworth
State/Province
London
ZIP/Postal Code
TW7 6FY
Country
United Kingdom
Facility Name
MAC Clinical Research
City
Cannock
State/Province
Staffordshire
ZIP/Postal Code
WS11 0BN
Country
United Kingdom
Facility Name
Re-Cognition Health Ltd
City
Guildford
State/Province
Surrey
ZIP/Postal Code
GU2 7YD
Country
United Kingdom
Facility Name
Glasgow Memory Clinic
City
Glasgow
ZIP/Postal Code
G20 0XA
Country
United Kingdom
Facility Name
MAC Clinical Research
City
Leeds
ZIP/Postal Code
LS10 1DU
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/
Links:
URL
https://www.lillytrialguide.com/en-US/studies/alzheimer-s/AZFD#?postal=
Description
Click here for more information about this study: A Study of LY3314814 in Early Alzheimer's Disease Dementia
URL
https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=16557&attachmentIdentifier=a046bc93-718a-4179-8f30-4b65da56a317&fileName=CSP_NCT02972658.pdf&versionIdentifier=
Description
CSP
URL
https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=16557&attachmentIdentifier=a6ee5d0a-4796-4efd-b082-e84fbcbac489&fileName=SAP_NCT02972658.pdf&versionIdentifier=
Description
SAP

Learn more about this trial

A Study of Lanabecestat (LY3314814) in Early Alzheimer's Disease Dementia

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