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

NCT ID: NCT02972658

Last Updated: 2019-12-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

421 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-15

Study Completion Date

2018-10-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Alzheimer's Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

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

Group Type EXPERIMENTAL

Lanabecestat

Intervention Type DRUG

Administered orally

AZES Lanabecestat 50 mg/AZFD Lanabecestat 50 mg

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

Group Type EXPERIMENTAL

Lanabecestat

Intervention Type DRUG

Administered orally

AZES Placebo/AZFD Lanabecestat 20 mg

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

Group Type EXPERIMENTAL

Lanabecestat

Intervention Type DRUG

Administered orally

AZES Placebo/AZFD Lanabecestat 50 mg

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

Group Type EXPERIMENTAL

Lanabecestat

Intervention Type DRUG

Administered orally

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lanabecestat

Administered orally

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

LY3314814 AZD3293

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Eli Lilly and Company

INDUSTRY

Sponsor Role collaborator

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Banner Alzheimer's Institute

Phoenix, Arizona, United States

Site Status

Territory Neurology & Research Institute

Tucson, Arizona, United States

Site Status

Pacific Research Network Inc

San Diego, California, United States

Site Status

Mile High Research Center

Denver, Colorado, United States

Site Status

Institute for Neurodegenerative Disorders

New Haven, Connecticut, United States

Site Status

Georgetown University Medical Center

Washington D.C., District of Columbia, United States

Site Status

Brain Matters Research

Delray Beach, Florida, United States

Site Status

Compass Research

Orlando, Florida, United States

Site Status

IMIC, Inc.

Palmetto Bay, Florida, United States

Site Status

Roskamp Institute

Sarasota, Florida, United States

Site Status

Suncoast Neuroscience Associates

St. Petersburg, Florida, United States

Site Status

Premiere Research Institute at Palm Beach Neurology

West Palm Beach, Florida, United States

Site Status

The Multiple Sclerosis Center of Atlanta

Atlanta, Georgia, United States

Site Status

University of Chicago Medical Center

Chicago, Illinois, United States

Site Status

Community Clinical Research Center

Anderson, Indiana, United States

Site Status

Boston Center for Memory

Newton, Massachusetts, United States

Site Status

Hattiesburg Clinic

Hattiesburg, Mississippi, United States

Site Status

Memory Enhancement Center of America, Inc.

Eatontown, New Jersey, United States

Site Status

The Cognitive and Research Center of NJ

Springfield, New Jersey, United States

Site Status

Advanced Memory Research Institute of New Jersey

Toms River, New Jersey, United States

Site Status

Integrative Clinical Trials, LLC

Brooklyn, New York, United States

Site Status

Columbia University Medical Center

New York, New York, United States

Site Status

University of Rochester School of Medicine

Rochester, New York, United States

Site Status

Valley Medical Primary Care

Centerville, Ohio, United States

Site Status

Lindner Research Center

Cincinnati, Ohio, United States

Site Status

Ohio State University Medical Center

Columbus, Ohio, United States

Site Status

Lehigh Valley Hospital

Allentown, Pennsylvania, United States

Site Status

Rhode Island Mood & Memory Research Institute

East Providence, Rhode Island, United States

Site Status

Radiant Research

Greer, South Carolina, United States

Site Status

Quillen College of Medicine, East TN State University

Johnson City, Tennessee, United States

Site Status

The Memory Clinic

Bennington, Vermont, United States

Site Status

Southern Neurology

Kogarah, New South Wales, Australia

Site Status

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Site Status

Eastern Clinical Research Unit

Box Hill, Victoria, Australia

Site Status

Delmont Private Hospital

Glen Iris, Victoria, Australia

Site Status

The Florey Institute of Neuroscience and Mental Health

Parkville, Victoria, Australia

Site Status

Australian Alzheimer's Research Foundation

Nedlands, Western Australia, Australia

Site Status

Neuro Trials Victoria Pty Ltd

Noble Park, , Australia

Site Status

Jessa Ziekenhuis

Hasselt, Limburg, Belgium

Site Status

Hopital Universitaire Brugmann Brussel

Brussels, , Belgium

Site Status

Hospital Universitaire Erasme Brussel

Brussels, , Belgium

Site Status

Cliniques Universitaires Saint-Luc

Brussels, , Belgium

Site Status

Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

Leuven, , Belgium

Site Status

AZ Delta

Roeselare, , Belgium

Site Status

Okanagan Clinical Trials

Kelowna, British Columbia, Canada

Site Status

True North Clinical Research Halifax, LLC

Halifax, Nova Scotia, Canada

Site Status

Elizabeth Bruyere Health Centre

Ottawa, Ontario, Canada

Site Status

Kawartha Regional Memory Clinic

Peterborough, Ontario, Canada

Site Status

Toronto Memory Program

Toronto, Ontario, Canada

Site Status

Clinique de la Memoire de l'Outaouais

Gatineau, Quebec, Canada

Site Status

NeuroSearch Developements

Greenfield Park, Quebec, Canada

Site Status

Hopital de L'Enfant Jesus

Québec, Quebec, Canada

Site Status

Q&T Research Sherbrooke Inc

Sherbrooke, Quebec, Canada

Site Status

Centre Hospitalier Universitaire La Timone

Marseille, Cedex 05, France

Site Status

CHRU de Lille- Hôpital Roger Salengro

Lille, Cedex, France

Site Status

CHU de Toulouse Hopital Purpan

Toulouse, Cedex, France

Site Status

Hopital Neuro Pierre Wertheimer

Bron, , France

Site Status

CHU Bocage CMRR

Dijon, , France

Site Status

Hopital Broca

Paris, , France

Site Status

Hôpital de la Pitié-Salpêtrière

Paris, , France

Site Status

Hôpital Fernand Widal

Paris, , France

Site Status

Chu de Nantes Hopital Laennec

Saint-Herblain, , France

Site Status

Centre de Recherche Clinique du Gérontopôle Cité de la Santé

Toulouse, , France

Site Status

Hopital des Charpennes

Villeurbanne, , France

Site Status

Universitätsklinikum Ulm

Ulm, Baden-Wurttemberg, Germany

Site Status

Studien und Gedächtniszentrum München

München, Bavaria, Germany

Site Status

Klinikum Rechts der Isar der TU München

München, Bavaria, Germany

Site Status

Gemeinschaftspraxis für Neurologie und Psychiatrie

Westerstede, Lower Saxony, Germany

Site Status

DataMed Klinische Studien GmbH

Cologne, North Rhine-Westphalia, Germany

Site Status

Universitätsklinikum Köln

Cologne, North Rhine-Westphalia, Germany

Site Status

Neurologische Praxis Siegen

Siegen, North Rhine-Westphalia, Germany

Site Status

Pharm Studienzentrum Chemnitz

Mittweida, Saxony, Germany

Site Status

Charité Universitätsmedizin Berlin

Berlin, , Germany

Site Status

Charité Universitätsmedizin Berlin

Berlin, , Germany

Site Status

SE Neurologiai Klinika

Budapest, , Hungary

Site Status

National Institute for Longevity Sciences NCGG

Ōbu, Aichi-ken, Japan

Site Status

National Chiba-East-Hospital

Chuo-ku, Chiba, Japan

Site Status

Tsukuba University Hospital

Tsukuba, Ibaraki, Japan

Site Status

Iwate Medical University Hospital

Morioka, Iwate, Japan

Site Status

Nihon Kokan Hospital

Kawasaki, Kanagawa, Japan

Site Status

Katayama Medical Clinic

Kurashiki, Okayama-ken, Japan

Site Status

Shiroma Clinic

Urasoe, Okinawa, Japan

Site Status

Sakaguchi Clinic

Sakai, Osaka, Japan

Site Status

National Sanatorium Toneyama Hospital

Toyonaka, Osaka, Japan

Site Status

Memory Clinic Ochanomizu

Bunkyo-ku, Tokyo, Japan

Site Status

Nippon Medical School Hospital

Bunkyo-Ku, Tokyo, Japan

Site Status

The University of Tokyo Hospital

Bunkyo-ku, Tokyo, Japan

Site Status

Tokyo Women's Medical University Hospital

Shinjuku-ku, Tokyo, Japan

Site Status

National Sanatorium Hokuriku Hospital

Nanto, Toyama, Japan

Site Status

Fukuoka University Hospital

Fukuoka, , Japan

Site Status

Kyoto University Hospital

Kyoto, , Japan

Site Status

Utano Hospital

Kyoto, , Japan

Site Status

Osaka City University Hospital

Osaka, , Japan

Site Status

Podlaskie Centrum Psychogeriatrii

Bialystok, Podlaskie Voivodeship, Poland

Site Status

NZOZ Dom Sue Ryder - Pallmed Sp. z o.o.

Bydgoszcz, , Poland

Site Status

NZOZ Wielospecjalistyczna Poradnia Lekarska

Katowice, , Poland

Site Status

Centrum Zdrowia Psychicznego Biomed - Jan Latala

Kielce, , Poland

Site Status

Krakowska Akademia Neurologii

Krakow, , Poland

Site Status

Medycyna Milorzab

Lodz, , Poland

Site Status

Instytut Medycyny Wsi

Lublin, , Poland

Site Status

Centrum Medyczne Neuroprotect

Warsaw, , Poland

Site Status

Santa Cruz Behavioral PSC

Bayamón, , Puerto Rico

Site Status

SC Med Life SA

Bucharest, , Romania

Site Status

SC Centrul Medical Sana SRL

Bucharest, , Romania

Site Status

Dong-A University Medical Center

Seogu, Busan, South Korea

Site Status

Hanyang University Guri Hospital

Guri-si, Gyeonggido, South Korea

Site Status

Inha University Hospital

Junggu, Incheon, South Korea

Site Status

Samsung Medical Center

Seoul, Korea, South Korea

Site Status

Gachon University Gil Medical Center

Incheon, , South Korea

Site Status

Asan Medical Center

Seoul, , South Korea

Site Status

Seoul St. Mary's Hospital

Seoul, , South Korea

Site Status

Hospital General Universitario de Elche

Elche, Alicante, Spain

Site Status

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Site Status

Hospital Virgen Del Puerto

Plasencia, Caceres, Spain

Site Status

Hospital Universitario De Getafe

Madrid, Getafe, Spain

Site Status

CITA Alzheimer

Donostia / San Sebastian, Guipuzcoa, Spain

Site Status

Centro de Atencion Especializada (CAE) OROITU

Getxo, Vizcaya, Spain

Site Status

Fundacion ACE-Institut Catala de Neurociences Aplicades

Barcelona, , Spain

Site Status

Hospital Santa Creu I Sant Pau

Barcelona, , Spain

Site Status

Hospital Clinic I Provincial

Barcelona, , Spain

Site Status

Hospital De La Princesa

Madrid, , Spain

Site Status

Hospital Universitario Ramon y Cajal

Madrid, , Spain

Site Status

Hospital Son Espases

Palma de Mallorca, , Spain

Site Status

Hospital Universitario Dr Pesset

Valencia, , Spain

Site Status

Hospital Universitario La Fe de Valencia

Valencia, , Spain

Site Status

Re-Cognition Health Ltd

London, Greater London, United Kingdom

Site Status

MAC Clinical Research-Manchester

Manchester, Greater Manchester, United Kingdom

Site Status

MAC Clinical Research

Blackpool, Lancashire, United Kingdom

Site Status

West London Mental Health NHS Trust

Isleworth, London, United Kingdom

Site Status

MAC Clinical Research

Cannock, Staffordshire, United Kingdom

Site Status

Re-Cognition Health Ltd

Guildford, Surrey, United Kingdom

Site Status

Glasgow Memory Clinic

Glasgow, , United Kingdom

Site Status

MAC Clinical Research

Leeds, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Australia Belgium Canada France Germany Hungary Japan Poland Puerto Rico Romania South Korea Spain United Kingdom

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

I8D-MC-AZFD

Identifier Type: OTHER

Identifier Source: secondary_id

2016-003440-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

16557

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.