A Randomized, Double-Blind, Placebo-Controlled and Delayed-Start Study of LY3314814 in Mild Alzheimer's Disease Dementia
Status: Terminated
Location: See all (253) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The main purpose of this study is to evaluate the efficacy of the study drug known as lanabecestat in participants with mild Alzheimer's disease (AD) dementia.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 55
Maximum Age: 85
Healthy Volunteers: f
View:
• Participant must meet the National Institute on Aging (NIA) and the Alzheimer's Association (AA) (NIA-AA) criteria for probable AD dementia.
• MMSE score of 20 to 26 inclusive at screening visit.
• For a diagnosis of mild AD dementia, participant must have a CDR global score of 0.5 or 1, with the memory box score ≥0.5 at screening.
• Evidence of amyloid pathology.
• The participant must have a reliable study partner with whom he/she cohabits or has regular contact.
Locations
United States
Arkansas
NEA Baptist Clinical
Jonesboro
Arizona
St Josephs Hospital and Medical Center
Phoenix
Xenoscience
Phoenix
Arizona Neurology
Scottsdale
Four Peaks Neurology
Scottsdale
Center for Neurosciences
Tucson
California
The Research Center of Southern California
Carlsbad
WCCT Global
Costa Mesa
Neuro-Pain Medical Center
Fresno
Neurology Center of North Orange County
Fullerton
Pacific Neuroscience Medical Group
Oxnard
California Research Foundation
San Diego
Pacific Research Network Inc
San Diego
Sharp Mesa Vista Hospital
San Diego
Syrentis Clinical Research
Santa Ana
Care Access Research
Santa Clarita
California Neuroscience Research
Sherman Oaks
Care Access Research
Valencia
Connecticut
Associated Neurologists, PC - Danbury
Danbury
Institute for Neurodegenerative Disorders
New Haven
Yale University School of Medicine
New Haven
Research Center for Clinical Studies, Inc
Norwalk
Florida
JEM Research Institute
Atlantis
Morton Plant Hospital
Clearwater
Brain Matters Research
Delray Beach
Cohen Medical Associates P.A.
Delray Beach
Neuropsychiatric Research Center of Southwest Florida
Fort Myers
Indago Research & Health Center, Inc.
Hialeah
Infinity Clinical Research, LLC
Hollywood
Jacksonville Center for Clinical Research
Jacksonville
Mayo Clinic-Jacksonville
Jacksonville
Gregory A. Kirk MD LLC
Merritt Island
Allied Biomedical Research Institute, Inc.
Miami
University of Miami
Miami
Compass Research
Orlando
Quantum Laboratories
Pompano Beach
Charlotte Neurological Services
Port Charlotte
Intercoastal Medical Group
Sarasota
Axiom Research
Tampa
University of South Florida
Tampa
Georgia
Atlanta Center of Medical Research
Atlanta
Emory University
Atlanta
Georgia Regents University
Augusta
Medical Research Health and Education Foundation, Inc
Columbus
Hawaii
Hawaii Medical Center
Honolulu
Idaho
Advanced Clinical Research LLC
Meridian
Indiana
American Health Network
Avon
Josephson Wallack Munshower Neurology
Indianapolis
American Health Network
Muncie
Kansas
University of Kansas Hospital
Fairway
Cotton O'Neil Clinic
Topeka
Via Christi Research, Inc.
Wichita
Kentucky
Associates in Neurology, PSC
Lexington
Baptist Health Medical Group
Lexington
Massachusetts
Boston University Medical Center
Boston
Donald S Marks
Plymouth
Alzheimers Disease Center
Winchester
Maine
Eastern Maine Medical Center
Bangor
Maine Neurology
Scarborough
Michigan
Michigan State University
East Lansing
Missouri
Clinical Research Professionals
Saint Louis
Mississippi
Hattiesburg Clinic
Hattiesburg
North Carolina
Behavioral Health Center Research
Charlotte
Raleigh Neurology Associates
Raleigh
PMG Research of Winston-Salem, LLC
Winston-salem
Wake Forest Baptist Univ CAR
Winston-salem
New Jersey
Advanced Memory Research Institute of New Jersey
Toms River
Neurology Specialists of Monmouth County
West Long Branch
Nevada
Las Vegas Medical Research
Las Vegas
New York
New York University Medical Center
New York
Ohio
Rapid Medical Research Inc
Cleveland
Ohio State University Medical Center
Columbus
Insight Clinical Trials
Shaker Heights
Oklahoma
Cutting Edge Research Group
Oklahoma City
Lynn Health Science Institute
Oklahoma City
Oregon
The Corvallis Clinic P.C.
Corvallis
Summit Research Network Inc
Portland
Pennsylvania
Clinical Trial Center, LLC, Psychiatry
Jenkintown
Pearl Clinical Research Inc.
Norristown
Rhode Island
Rhode Island Mood & Memory Research Institute
East Providence
Butler Hospital
Providence
Rhode Island Hospital
Providence
South Carolina
Medical University of South Carolina
Charleston
Radiant Research
Greer
Coastal Neurology PA
Port Royal
Tennessee
Holston Medical Group Clinical Research
Kingsport
Texas
Univ of North Texas Health Science Center
Fort Worth
Texas Medical Research Associates, L.L.C.
San Antonio
Utah
Ericksen Research and Development
Clinton
Wisconsin
SSM Health Dean Medical Group
Madison
Other Locations
Canada
University of Calgary
Calgary
Recherches Neuro-Hippocampe Inc
Gatineau
True North Clinical Research Halifax, LLC
Halifax
Bruyere Continuing Care
Ottawa
Kawartha Regional Memory Clinic
Peterborough
CSSS-Institut Universitaire Gériatric de Sherbrooke
Sherbrooke
Q&T Research Sherbrooke Inc
Sherbrooke
Toronto Memory Program
Toronto
Toronto Sunnybrook Regional Cancer Center
Toronto
Douglas Hospital and Research Centre
Verdun
The Medical Arts Health Research Group
West Vancouver
China
Beijing 301 Hospital
Beijing
Xuanwu Hospital-Capital Medical University
Beijing
West China Hospital of Sichuan University
Chengdu
Guangzhou First People's Hospital
Guangzhou
The First Affiliated Hospital, Zhejiang University
Hangzhou
Nanjing Drum Tower Hosp Affiliated Hosp of Nanjing Univ Med
Nanjing
Zhongda Hospital-Southeast University
Nanjing
Qingdao Municipal Hospital
Qingdao
Shanghai Huashan Hospital Affil to Fu Dan University
Shanghai
Shanghai Tongji Hospital(CCBR site)
Shanghai
Tangshan Worker Hospital
Tangshan
The First Affiliated Hospital of Wenzhou Medical College
Wenzhou
Northern Jiangsu People's Hospital
Yangzhou
Denmark
CCBR-Alborg-DK
Aalborg
Center For Clinical and Basic Research
Ballerup
Rigshospitalet
Copenhagen
Center for Clinical and Basic Research -CCBR
Vejle
France
CHU d'Amiens-Picardie Hopital Sud
Amiens Cedex 1
CHU de Caen Hopital Cote de Nacre
Caen Cedex
APHM Hôpital de la Timone
Marseille
Institut Claude Pompidou - CMRR
Nice
Hôpital de la Pitié-Salpêtrière
Paris
CHU Rennes/Hopital Sud
Rennes Cedex
CHU Saint Etienne - Hopital Nord
Saint Priest En Jarez
CHU Strasbourg Hôpital de Hautepierre
Strasbourg Cedex
Chu de Toulouse Hopital de La Grave
Toulouse Cedex
Chu De Nancy Hop D'Adultes De Brabois
Vandœuvre-lès-nancy
Germany
MVZ LiO Berlin
Berlin
Praxis Dr. Erich Scholz
Böblingen
Diakoniekrankenhaus Henriettenstiftung Hannover
Hannover
ISPG - Institut für Studien zur psychischen Gesundheit
Mannheim
Klinikum der Universität München
München
Klinikum Rechts der Isar der TU München
München
Praxis für Neurologie und Psychiatrie Dr. med. Roth
Ostfildern
Neurozentrum Sophienstraße
Stuttgart
Neuropraxis München Süd
Unterhaching
Italy
Spedali Civili - Universita degli Studi
Brescia
Azienda Ospedaliera Universitaria Careggi
Firenze
Ente Ospedaliero Ospedali Galliera
Genova
IRCCS Azienda Ospedaliera Universitaria San Martino
Genova
SDN - Istituto di Ricerca Diagnostica e Nucleare
Napoli
Azienda Ospedaliera - Universitaria Pisana
Pisa
IRCCS Santa Lucia
Roma
Policlinico Univ. Agostino Gemelli
Roma
Universita La Sapienza
Roma
Azienda Ospedaliera Citta della Salute della Scienza Torino
Torino
Japan
Takeda General Hospital
Aizu-wakamatsu
Shinwakai Yachiyo Hospital
Anjo-shi
Aomori Prefectural Centeral Hospital
Aomori
Juntendo University Hospital
Bunkyo-ku
Memory Clinic Ochanomizu
Bunkyo-ku
Inage Neurology and Memory Clinic
Chiba-shi
Keikokai P-One Clinic
Hachioji-shi
Koseikai Kusatsu Hospital
Hiroshima-shi
NHO Hizen Psychiatric Center
Kanzaki-gun
Nara Medical University Hospital
Kashihara
Ikeuchi Psycho Induced Internal Clinic
Kobe-shi
Yuge Hospital
Kumamoto
Katayama Medical Clinic
Kurashiki-shi
Koseikai Takeda Hospital
Kyoto-shi
Musashino Red Cross Hospital
Musashino
Kojunkai Daido Hospital
Nagoya-shi
Nagoya Ekisaikai Hospital
Nagoya-shi
JADECOM Nara City Hospital
Nara-shi
NHO Niigata Hospital
Niigata
Himuro Neurology Clinic
Osaka-shi
Kotobukikai Tominaga Clinic
Osaka-shi
NHO Hiroshima-Nishi Medical Center
Otaki-shi
NHO Hokkaido Medical Center
Sapporo-shi
Jisenkai Nanko Psychiatric Institute
Shirakawa-shi
Shimizu Hospital
Shizuoka-shi
Kousaiin Hospital
Suita-shi
Ehime University Hospital
Toon-shi
Uji Takeda Hospital
Uji-shi
Yokohama Hospital
Yokohama
JOHAS Sanin Rosai Hospital
Yonago-shi
Oita University Hospital
Yufu-shi
Mexico
Mexico Centre for Clinical Research SA de CV
Mexico City
Accelerium Clinical Research
Monterrey
Avix Investigación Clínica, S.C
Monterrey
Centro de Estudios Clinicos y Esp Medicas SC
Monterrey
Hospital Univ. Jose Eleuterio Gonzalez
Monterrey
Instituto de Informacion en Salud Mental (INFOSAM)
Monterrey
Hospital Universitario de Saltillo
Saltillo
Clinical Research Institute S C
Tlalnepantla
Netherlands
Emotional Brain B.V.
Almere
Brain Research Center
Amsterdam
Amphia Ziekenhuis
Breda
EB Utrecht
Utrecht
Isala Klinieken
Zwolle
Poland
Podlaskie Centrum Psychogeriatrii
Białystok
NZOZ Mach-Med
Chorzow
Uniwersyteckie Centrum Kliniczne
Gdansk
Klinika Neurologii Neuro-Care
Katowice
Globe Badania Kliniczne SP Z O.O.
Klodzko
Prywatny Gabinet Lekarski U.Chyrchel
Lublin
Centrum Medyczne Medyk
Rzeszow
Euromedis Sp. z o.o.
Szczecin
Clinsante Centrum Medyczne
Torun
Centrum Medyczne
Warszawa
Specjalistyczny Osrodek Medycyny Wieku Dojrzalego SOMED
Warszawa
NZOZ Wroclawskie Centrum Alzheimerowskie
Wroclaw
Portugal
Hospital Fernando Fonseca
Amadora
Hospital de Braga
Braga
Hospitals da Universidade de Coimbra
Coimbra
Republic of Korea
The Catholic University of Korea-Bucheon St. Mary's Hospital
Bucheon-si
Dong-A University Medical Center
Busan
Myongji Hospital
Goyang-si
Inha University Hospital
Incheon
Seoul National University Bundang Hospital
Seongnam-si
Hanyang University Medical Center
Seoul
Konkuk University Hospital
Seoul
Korea University Anam Hospital
Seoul
Samsung Medical Center
Seoul
Seoul National University Hospital
Seoul
Russian Federation
SAIH Republ. Clinical Hospital of the MoH of Republ. Tatarst
Kazan
SIH Kemerovo Regional Clinical Hosptial
Kemerovo
FSBIH Siberian Clinical Center of FMBA
Krasnoyarsk
LLC City Neurological Centre Sibneuromed
Novosibirsk
Novosibirsk State Medical University
Novosibirsk
Ultramed
Omsk
LLC Treatment and Rehabilitation
Rostov-on-don
RSBIH Smolensk Regional Clinical Hospital
Smolensk
Bekhterev Psyconeurological Institute
St. Petersburg
Central Medical Sanitary Hospital #122
St. Petersburg
Regional State Institution of Healthcare Tomsk Clinica Psych
Tomsk
Spain
Hospital Ntra Sra Perpetuo Socorro
Albacete
Fundacion ACE-Institut Catala de Neurociences Aplicades
Barcelona
Hospital del Mar
Barcelona
Policlinica Guipuzcoa
Donostia
Hospital Virgen Del Puerto
Plasencia
Hospital Cardiovascular San Vicente
San Vicente Del Raspeig
Hospital General de Catalunya
Sant Cugat Del Valles
Hospital Mutua de Terrassa
Terrassa
Hospital Universitario La Fe de Valencia
Valencia
Taiwan
Changhua Christian Hospital
Changhua
National Taiwan University Hospital
Douliu
Chang Gung Memorial Hospital - Kaohsiung
Kaohsiung
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung
Taipei Medical University- Shuang Ho Hospital
New Taipei
Cardinal Tien Hospital
Sindian City
National Cheng Kung University Hospital
Tainan
Taipei Veterans General Hospital
Taipei
Chang Gung Memorial Hospital - Linkou
Taoyuan City
United Kingdom
Charlton Lane Hospital
Cheltenham
Royal Devon and Exeter Hospital
Exeter
Glasgow Memory Clinic
Glasgow
Re-Cognition Health Ltd
Guildford
Re-Cognition Health Ltd
London
Murray Royal Hospital
Perth
Re-Cognition Health Ltd
Plymouth
Victoria Centre
Swindon
Time Frame
Start Date: 2016-07-01
Completion Date: 2018-09-28
Participants
Target number of participants: 1722
Treatments
Experimental: Lanabecestat 20 milligrams (mg)
Participants received Lanabecestat 20 mg film-coated tablets orally once daily until week 156.
Experimental: Lanabecestat 50 mg
Participants received Lanabecestat 50 mg film-coated tablets orally once daily until week 156.
Experimental: Placebo/ Lanabecestat 20 mg
Placebo given orally once daily for 78 weeks and then 20 mg of lanabecestat given orally once daily until week 156.
Experimental: Placebo/ Lanabecestat 50 mg
Placebo given orally once daily for 78 weeks and then 50 mg of lanabecestat given orally once daily until week 156.
Authors
Maria Strachunskaya, Paul Murphy, Patrick Peters, Gregory Kirk, James Sutton, Tyler Dixon, Susan Steen, John Duffy, Brian Ott, Willis Holloway, William Ellison, Samuel Markind, Surisham Dhillon, Robert Stern, Ronald Schwartz, Carl Griffin, Marvin Kalafer, Michael Pfeffer, D BRANDON, Kore Liow, KRISTI GEORGE, Harvey Schwartz, Kaycee Sink, Bart Sloan, Mark Benson, JOSEPH TORNABENE, BENJAMIN FRISHBERG, Kenneth Chan, Perminder Bhatia, Constantine Moschonas, Scott Teeter, Mehdi Meratee, Mary Manning, Jonathan Condit, Timothy Jennings, Bharat Mocherla, David Russell, Janice Knebl, Douglas Scharre, John Olichney, David Morin, Diana Pollock, Mark Goldstein, Johnson Moon, Erin Doty, Deborah Gould, Eric Dinnerstein, Melanie Shulman, Paul Mazzeo, Gregory Jicha, Donald Marks, Robert Riesenberg, Anne Koplin, Marwan Sabbagh, Corey Ericksen, Stephen Flitman, Giles Crowell, Bradley Robottom, Roginelli Yu, Dennis Swearingen, Noah Gilson, Fayz Hudefi, John Morgan, Allan Levey, Clifford Singer, John Stoukides, Weijia Wang, Ramon Gil, Mark Turner, Mark Brody, Oleg Tcheremissine, Steven Macina, Jose Cardona, Mary Quiceno, Robert Cohen, Adam Boxer, Stephen Salloway, JERRY STEIERT, Jonathan Liss, Robert Pearlstein, Sanjiv Sharma, Felix Bischof, Klaus Hager, Katharina Bürger, Timo Grimmer, Jeffrey Burns, Anil Nair, Michael Rosenbloom, Andrea Bozoki, Olga Doronina, Jincai He, Benyan Luo, Xiaoping Pan, Lan Tan, Weihong Kuang, Santiago Ponce Aix
Related Therapeutic Areas
Sponsors
Leads: AstraZeneca
Collaborators: Eli Lilly and Company