A Study of Lanabecestat (LY3314814) in Early Alzheimer's Disease Dementia
NCT ID: NCT02972658
Last Updated: 2019-12-03
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
421 participants
INTERVENTIONAL
2017-03-15
2018-10-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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.
Lanabecestat
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.
Lanabecestat
Administered orally
AZES Placebo/AZFD Lanabecestat 20 mg
Participants who received placebo in the feeder study (AZES) were randomized to receive Lanabecestat 20 mg.
Lanabecestat
Administered orally
AZES Placebo/AZFD Lanabecestat 50 mg
Participants who received placebo in the feeder study (AZES) were randomized to receive Lanabecestat 50 mg.
Lanabecestat
Administered orally
Interventions
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Lanabecestat
Administered orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
55 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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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
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Banner Alzheimer's Institute
Phoenix, Arizona, United States
Territory Neurology & Research Institute
Tucson, Arizona, United States
Pacific Research Network Inc
San Diego, California, United States
Mile High Research Center
Denver, Colorado, United States
Institute for Neurodegenerative Disorders
New Haven, Connecticut, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Brain Matters Research
Delray Beach, Florida, United States
Compass Research
Orlando, Florida, United States
IMIC, Inc.
Palmetto Bay, Florida, United States
Roskamp Institute
Sarasota, Florida, United States
Suncoast Neuroscience Associates
St. Petersburg, Florida, United States
Premiere Research Institute at Palm Beach Neurology
West Palm Beach, Florida, United States
The Multiple Sclerosis Center of Atlanta
Atlanta, Georgia, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Community Clinical Research Center
Anderson, Indiana, United States
Boston Center for Memory
Newton, Massachusetts, United States
Hattiesburg Clinic
Hattiesburg, Mississippi, United States
Memory Enhancement Center of America, Inc.
Eatontown, New Jersey, United States
The Cognitive and Research Center of NJ
Springfield, New Jersey, United States
Advanced Memory Research Institute of New Jersey
Toms River, New Jersey, United States
Integrative Clinical Trials, LLC
Brooklyn, New York, United States
Columbia University Medical Center
New York, New York, United States
University of Rochester School of Medicine
Rochester, New York, United States
Valley Medical Primary Care
Centerville, Ohio, United States
Lindner Research Center
Cincinnati, Ohio, United States
Ohio State University Medical Center
Columbus, Ohio, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, United States
Rhode Island Mood & Memory Research Institute
East Providence, Rhode Island, United States
Radiant Research
Greer, South Carolina, United States
Quillen College of Medicine, East TN State University
Johnson City, Tennessee, United States
The Memory Clinic
Bennington, Vermont, United States
Southern Neurology
Kogarah, New South Wales, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Eastern Clinical Research Unit
Box Hill, Victoria, Australia
Delmont Private Hospital
Glen Iris, Victoria, Australia
The Florey Institute of Neuroscience and Mental Health
Parkville, Victoria, Australia
Australian Alzheimer's Research Foundation
Nedlands, Western Australia, Australia
Neuro Trials Victoria Pty Ltd
Noble Park, , Australia
Jessa Ziekenhuis
Hasselt, Limburg, Belgium
Hopital Universitaire Brugmann Brussel
Brussels, , Belgium
Hospital Universitaire Erasme Brussel
Brussels, , Belgium
Cliniques Universitaires Saint-Luc
Brussels, , Belgium
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
Leuven, , Belgium
AZ Delta
Roeselare, , Belgium
Okanagan Clinical Trials
Kelowna, British Columbia, Canada
True North Clinical Research Halifax, LLC
Halifax, Nova Scotia, Canada
Elizabeth Bruyere Health Centre
Ottawa, Ontario, Canada
Kawartha Regional Memory Clinic
Peterborough, Ontario, Canada
Toronto Memory Program
Toronto, Ontario, Canada
Clinique de la Memoire de l'Outaouais
Gatineau, Quebec, Canada
NeuroSearch Developements
Greenfield Park, Quebec, Canada
Hopital de L'Enfant Jesus
Québec, Quebec, Canada
Q&T Research Sherbrooke Inc
Sherbrooke, Quebec, Canada
Centre Hospitalier Universitaire La Timone
Marseille, Cedex 05, France
CHRU de Lille- Hôpital Roger Salengro
Lille, Cedex, France
CHU de Toulouse Hopital Purpan
Toulouse, Cedex, France
Hopital Neuro Pierre Wertheimer
Bron, , France
CHU Bocage CMRR
Dijon, , France
Hopital Broca
Paris, , France
Hôpital de la Pitié-Salpêtrière
Paris, , France
Hôpital Fernand Widal
Paris, , France
Chu de Nantes Hopital Laennec
Saint-Herblain, , France
Centre de Recherche Clinique du Gérontopôle Cité de la Santé
Toulouse, , France
Hopital des Charpennes
Villeurbanne, , France
Universitätsklinikum Ulm
Ulm, Baden-Wurttemberg, Germany
Studien und Gedächtniszentrum München
München, Bavaria, Germany
Klinikum Rechts der Isar der TU München
München, Bavaria, Germany
Gemeinschaftspraxis für Neurologie und Psychiatrie
Westerstede, Lower Saxony, Germany
DataMed Klinische Studien GmbH
Cologne, North Rhine-Westphalia, Germany
Universitätsklinikum Köln
Cologne, North Rhine-Westphalia, Germany
Neurologische Praxis Siegen
Siegen, North Rhine-Westphalia, Germany
Pharm Studienzentrum Chemnitz
Mittweida, Saxony, Germany
Charité Universitätsmedizin Berlin
Berlin, , Germany
Charité Universitätsmedizin Berlin
Berlin, , Germany
SE Neurologiai Klinika
Budapest, , Hungary
National Institute for Longevity Sciences NCGG
Ōbu, Aichi-ken, Japan
National Chiba-East-Hospital
Chuo-ku, Chiba, Japan
Tsukuba University Hospital
Tsukuba, Ibaraki, Japan
Iwate Medical University Hospital
Morioka, Iwate, Japan
Nihon Kokan Hospital
Kawasaki, Kanagawa, Japan
Katayama Medical Clinic
Kurashiki, Okayama-ken, Japan
Shiroma Clinic
Urasoe, Okinawa, Japan
Sakaguchi Clinic
Sakai, Osaka, Japan
National Sanatorium Toneyama Hospital
Toyonaka, Osaka, Japan
Memory Clinic Ochanomizu
Bunkyo-ku, Tokyo, Japan
Nippon Medical School Hospital
Bunkyo-Ku, Tokyo, Japan
The University of Tokyo Hospital
Bunkyo-ku, Tokyo, Japan
Tokyo Women's Medical University Hospital
Shinjuku-ku, Tokyo, Japan
National Sanatorium Hokuriku Hospital
Nanto, Toyama, Japan
Fukuoka University Hospital
Fukuoka, , Japan
Kyoto University Hospital
Kyoto, , Japan
Utano Hospital
Kyoto, , Japan
Osaka City University Hospital
Osaka, , Japan
Podlaskie Centrum Psychogeriatrii
Bialystok, Podlaskie Voivodeship, Poland
NZOZ Dom Sue Ryder - Pallmed Sp. z o.o.
Bydgoszcz, , Poland
NZOZ Wielospecjalistyczna Poradnia Lekarska
Katowice, , Poland
Centrum Zdrowia Psychicznego Biomed - Jan Latala
Kielce, , Poland
Krakowska Akademia Neurologii
Krakow, , Poland
Medycyna Milorzab
Lodz, , Poland
Instytut Medycyny Wsi
Lublin, , Poland
Centrum Medyczne Neuroprotect
Warsaw, , Poland
Santa Cruz Behavioral PSC
Bayamón, , Puerto Rico
SC Med Life SA
Bucharest, , Romania
SC Centrul Medical Sana SRL
Bucharest, , Romania
Dong-A University Medical Center
Seogu, Busan, South Korea
Hanyang University Guri Hospital
Guri-si, Gyeonggido, South Korea
Inha University Hospital
Junggu, Incheon, South Korea
Samsung Medical Center
Seoul, Korea, South Korea
Gachon University Gil Medical Center
Incheon, , South Korea
Asan Medical Center
Seoul, , South Korea
Seoul St. Mary's Hospital
Seoul, , South Korea
Hospital General Universitario de Elche
Elche, Alicante, Spain
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Virgen Del Puerto
Plasencia, Caceres, Spain
Hospital Universitario De Getafe
Madrid, Getafe, Spain
CITA Alzheimer
Donostia / San Sebastian, Guipuzcoa, Spain
Centro de Atencion Especializada (CAE) OROITU
Getxo, Vizcaya, Spain
Fundacion ACE-Institut Catala de Neurociences Aplicades
Barcelona, , Spain
Hospital Santa Creu I Sant Pau
Barcelona, , Spain
Hospital Clinic I Provincial
Barcelona, , Spain
Hospital De La Princesa
Madrid, , Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Hospital Son Espases
Palma de Mallorca, , Spain
Hospital Universitario Dr Pesset
Valencia, , Spain
Hospital Universitario La Fe de Valencia
Valencia, , Spain
Re-Cognition Health Ltd
London, Greater London, United Kingdom
MAC Clinical Research-Manchester
Manchester, Greater Manchester, United Kingdom
MAC Clinical Research
Blackpool, Lancashire, United Kingdom
West London Mental Health NHS Trust
Isleworth, London, United Kingdom
MAC Clinical Research
Cannock, Staffordshire, United Kingdom
Re-Cognition Health Ltd
Guildford, Surrey, United Kingdom
Glasgow Memory Clinic
Glasgow, , United Kingdom
MAC Clinical Research
Leeds, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Click here for more information about this study: A Study of LY3314814 in Early Alzheimer's Disease Dementia
Other Identifiers
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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
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