A Study of Lanabecestat (LY3314814) in Participants With Mild Alzheimer's Disease Dementia (DAYBREAK-ALZ)

A Randomized, Double-Blind, Placebo-Controlled and Delayed-Start Study of LY3314814 in Mild Alzheimer's Disease Dementia

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.

Study Overview

• Status: Terminated
• Conditions: Alzheimer's Disease
• Intervention / Treatment: Drug: Placebo; Drug: Lanabecestat

• Study Type: Interventional
• Enrollment (Actual): 1722
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 426
      • University of Calgary
  • British Columbia
    • West Vancouver, British Columbia, Canada, V7T223
      • The Medical Arts Health Research Group
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3S1M7
      • True North Clinical Research Halifax, LLC
  • Ontario
    • Ottawa, Ontario, Canada, K1N 5C8
      • Bruyère Continuing Care
    • Peterborough, Ontario, Canada, K9H2P4
      • Kawartha Regional Memory Clinic
    • Toronto, Ontario, Canada, M3B2S7
      • Toronto Memory Program
    • Toronto, Ontario, Canada, M4N 3M5
      • Toronto Sunnybrook Regional Cancer Center
  • Qubec
    • Sherbrooke, Qubec, Canada, J1J3H5
      • CSSS-Institut Universitaire Gériatric de Sherbrooke
  • Quebec
    • Gatineau, Quebec, Canada, J8T 8J1
      • Recherches Neuro-Hippocampe Inc
    • Sherbrooke, Quebec, Canada, J1J 2G2
      • Q&T Research Sherbrooke Inc
    • Verdun, Quebec, Canada, H4H 1R3
      • Douglas Hospital and Research Centre
• China
  • Shanghai, China, 200040
    • Shanghai Huashan Hospital Affil to Fu Dan University
  • Beijing
    • Beijing, Beijing, China, 100053
      • Xuanwu Hospital-Capital Medical University
    • Beijing, Beijing, China, 100853
      • Beijing 301 Hospital
  • Guangdong
    • Guangzhou, Guangdong, China, 510180
      • Guangzhou First People's Hospital
  • Hebei
    • Tangshan, Hebei, China, 063000
      • Tangshan Worker Hospital
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • Nanjing Drum Tower Hosp Affiliated Hosp of Nanjing Univ Med
    • Nanjing, Jiangsu, China, 210009
      • Zhongda Hospital-Southeast University
    • Yangzhou, Jiangsu, China, 225001
      • Northern Jiangsu People's Hospital
  • Shandong
    • Qingdao, Shandong, China, 266071
      • Qingdao Municipal Hospital
  • Shanghai
    • Shanghai, Shanghai, China, 200065
      • Shanghai Tongji Hospital(CCBR site)
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital of Sichuan University
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • The First Affiliated Hospital, Zhejiang University
    • Wenzhou, Zhejiang, China, 325035
      • The First Affiliated Hospital of Wenzhou Medical College
• Czechia
  • Brno, Czechia, 65691
    • Fakultni nemocnice u sv. Anny v Brne
  • Chocen, Czechia, 565 01
    • NEUROHK s.r.o.
  • Hradec Kralove, Czechia, 50009
    • Neuropsychiatrie s.r.o
  • Kladno, Czechia, 27201
    • BRAIN-SOULTHERAPY s.r.o
  • Plzen, Czechia, 31200
    • A-SHINE s.r.o.
  • Praha 10, Czechia, 100 00
    • CLINTRIAL, s.r.o.
  • Praha 6, Czechia, 16000
    • Medical Services Prague s.r.o.
  • Praha 6, Czechia, 160 00
    • Neuropsychiatrie s.r.o
  • Praha 8, Czechia, 182 00
    • Axon Clinical, s.r.o.
• Denmark
  • Aalborg, Denmark, 9100
    • CCBR-Alborg-DK
  • Ballerup, Denmark, 2750
    • Center for Clinical and Basic Research
  • Copenhagen, Denmark, 2100 CPH
    • Rigshospitalet
  • Vejle, Denmark, 7100
    • Center for Clinical and Basic Research -CCBR
• France
  • Amiens Cedex 1, France, 80054
    • CHU d'Amiens-Picardie Hopital Sud
  • Caen Cedex, France, 14033
    • CHU de Caen Hopital Cote de Nacre
  • Marseille, France, 13385
    • APHM Hopital de la Timone
  • Paris, France, 75013
    • Hôpital de la Pitié-Salpêtrière
  • Strasbourg Cedex, France, 67098
    • CHU Strasbourg Hôpital de Hautepierre
  • Toulouse Cedex, France, 31059
    • Chu de Toulouse Hopital de La Grave
  • Alpes Maritimes
    • Nice, Alpes Maritimes, France, 06100
      • Institut Claude Pompidou - CMRR
  • Ille Et Vilaine
    • Rennes Cedex, Ille Et Vilaine, France, 35064
      • CHU Rennes/Hopital Sud
  • Loire
    • Saint Priest en Jarez, Loire, France, 42270
      • CHU Saint Etienne - Hopital Nord
  • Meurthe-et-Moselle
    • Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France, 54511
      • Chu De Nancy Hop D'Adultes De Brabois
• Germany
  • Berlin, Germany, 12209
    • MVZ LiO Berlin
  • Baden-Württemberg
    • Böblingen, Baden-Württemberg, Germany, 71034
      • Praxis Dr. Erich Scholz
    • Mannheim, Baden-Württemberg, Germany, 68165
      • ISPG - Institut für Studien zur Psychischen Gesundheit
    • Ostfildern, Baden-Württemberg, Germany, 73760
      • Praxis für Neurologie und Psychiatrie Dr. med. Roth
    • Stuttgart, Baden-Württemberg, Germany, 70178
      • Neurozentrum Sophienstraße
  • Bayern
    • München, Bayern, Germany, 81675
      • Klinikum rechts der Isar der TU München
    • München, Bayern, Germany, 81377
      • Klinikum der Universität München
    • Unterhaching, Bayern, Germany, 82008
      • Neuropraxis München Süd
  • Niedersachsen
    • Hannover, Niedersachsen, Germany, 30559
      • Diakoniekrankenhaus Henriettenstiftung Hannover
• Italy
  • Brescia, Italy, 25123
    • Spedali Civili - Universita degli Studi
  • Firenze, Italy, 50134
    • Azienda Ospedaliera Universitaria Careggi
  • Genova, Italy, 16132
    • Irccs Azienda Ospedaliera Universitaria San Martino
  • Genova, Italy, 16128
    • Ente Ospedaliero Ospedali Galliera
  • Napoli, Italy, 80143
    • SDN - Istituto di Ricerca Diagnostica e Nucleare
  • Pisa, Italy, 56126
    • Azienda Ospedaliera - Universitaria Pisana
  • Roma, Italy, 00185
    • Università La Sapienza
  • Roma, Italy, 00179
    • IRCCS Santa Lucia
  • Torino, Italy, 10126
    • Azienda Ospedaliera Citta della Salute della Scienza Torino
  • Lazio
    • Roma, Lazio, Italy, 00168
      • Policlinico Univ. Agostino Gemelli
• Japan
  • Aomori, Japan, 030-8553
    • Aomori Prefectural Centeral Hospital
  • Kobe-shi, Japan, 655-0037
    • Ikeuchi Psycho Induced Internal Clinic
  • Kumamoto, Japan, 861-8002
    • Yuge Hospital
  • Niigata, Japan, 945-8585
    • NHO Niigata Hospital
  • Sapporo-shi, Japan, 063-0005
    • NHO Hokkaido Medical Center
  • Aichi-Ken
    • Anjo-shi, Aichi-Ken, Japan, 446-8510
      • Shinwakai Yachiyo Hospital
    • Nagoya-Shi, Aichi-Ken, Japan, 457-8511
      • Kojunkai Daido Hospital
    • Nagoya-shi, Aichi-Ken, Japan, 454-8502
      • Nagoya Ekisaikai Hospital
  • Chiba-Ken
    • Chiba-shi, Chiba-Ken, Japan, 263-0043
      • Inage Neurology and Memory Clinic
  • Ehime-Ken
    • Toon-Shi, Ehime-Ken, Japan, 791-0295
      • Ehime University Hospital
  • Fukushima
    • Aizu-Wakamatsu, Fukushima, Japan, 965-8585
      • Takeda General Hospital
  • Fukushima-Ken
    • Shirakawa-shi, Fukushima-Ken, Japan, 961-0021
      • Jisenkai Nanko Psychiatric Institute
  • Hiroshima-Ken
    • Hiroshima-shi, Hiroshima-Ken, Japan, 733-0864
      • Koseikai Kusatsu Hospital
    • Otaki-Shi, Hiroshima-Ken, Japan, 739-0696
      • NHO Hiroshima-Nishi Medical Center
  • Kanagawa
    • Yokohama, Kanagawa, Japan, 221-0801
      • Yokohama Hospital
  • Kyoto-Fu
    • Kyoto-Shi, Kyoto-Fu, Japan, 600-8558
      • Koseikai Takeda Hospital
    • Uji-Shi, Kyoto-Fu, Japan, 611-0021
      • Uji Takeda Hospital
  • Nara
    • Kashihara, Nara, Japan, 634-8522
      • Nara Medical University Hospital
  • Nara-Ken
    • Nara-Shi, Nara-Ken, Japan, 630-8305
      • JADECOM Nara City Hospital
  • Oita-Ken
    • Yufu-shi, Oita-Ken, Japan, 879-5593
      • Oita University Hospital
  • Okayama-Ken
    • Kurashiki-shi, Okayama-Ken, Japan, 710-0813
      • Katayama Medical Clinic
  • Osaka-Fu
    • Osaka-Shi, Osaka-Fu, Japan, 534-0021
      • Himuro Neurology Clinic
    • Osaka-shi, Osaka-Fu, Japan, 556-0015
      • Kotobukikai Tominaga Clinic
    • Suita-shi, Osaka-Fu, Japan, 565-0874
      • Kousaiin Hospital
  • Saga-Ken
    • Kanzaki-gun, Saga-Ken, Japan, 842-0192
      • NHO Hizen Psychiatric Center
  • Shizuoka
    • Shizuoka-shi, Shizuoka, Japan, 424-8636
      • Shimizu Hospital
  • Tokyo
    • Bunkyo-ku, Tokyo, Japan, 113-8431
      • Juntendo University Hospital
    • Bunkyo-ku, Tokyo, Japan, 113-0034
      • Memory Clinic Ochanomizu
    • Musashino, Tokyo, Japan, 180-8610
      • Musashino Red Cross Hospital
  • Tokyo-To
    • Hachioji-shi, Tokyo-To, Japan, 192-0071
      • Keikokai P-One Clinic
  • Tottori-Ken
    • Yonago-shi, Tottori-Ken, Japan, 683-8605
      • JOHAS Sanin Rosai Hospital
• Korea, Republic of
  • Incheon, Korea, Republic of, 22332
    • Inha University Hospital
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 02841
    • Korea University Anam Hospital
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center
  • Seoul, Korea, Republic of, 04763
    • Hanyang University Medical Center
  • Seoul, Korea, Republic of, 05030
    • Konkuk University Hospital
  • Busan Gwang'yeogsi
    • Busan, Busan Gwang'yeogsi, Korea, Republic of, 49201
      • Dong-A University Medical Center
  • Gyeonggi-do
    • Bucheon-si, Gyeonggi-do, Korea, Republic of, 14647
      • The Catholic University of Korea-Bucheon St. Mary's Hospital
    • Goyang-si, Gyeonggi-do, Korea, Republic of, 13620
      • Myongji Hospital
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
      • Seoul National University Bundang Hospital
• Mexico
  • Coahuila
    • Saltillo, Coahuila, Mexico, 25000
      • Hospital Universitario de Saltillo
  • Distrito Federal
    • Mexico City, Distrito Federal, Mexico, 03100
      • Mexico Centre for Clinical Research SA de CV
  • Edo De Mex
    • Tlalnepantla, Edo De Mex, Mexico, 54055
      • Clinical Research Institute S C
  • N.l.
    • Monterrey, N.l., Mexico, 64460
      • Hospital Univ. Jose Eleuterio Gonzalez
  • NL
    • Monterrey, NL, Mexico, 64710
      • Instituto de Informacion en Salud Mental (INFOSAM)
  • Nuevo Leon
    • Monterrey, Nuevo Leon, Mexico, 64000
      • Accelerium Clinical Research
    • Monterrey, Nuevo Leon, Mexico, 64620
      • Centro de Estudios Clinicos y Esp Medicas SC
  • Nuevo León
    • Monterrey, Nuevo León, Mexico, 64710
      • Avix Investigación Clínica, S.C
• Netherlands
  • Almere, Netherlands, 1311 RL
    • Emotional Brain B.V.
  • Amsterdam, Netherlands, 1081 GM
    • Brain Research Center
  • Breda, Netherlands, 4818 CK
    • Amphia Ziekenhuis
  • Utrecht, Netherlands, 3511 NH
    • EB Utrecht
  • Zwolle, Netherlands, 8025 AB
    • Isala Klinieken
• Poland
  • Chorzow, Poland, 41-506
    • NZOZ Mach-Med
  • Katowice, Poland, 40749
    • Klinika Neurologii Neuro-Care
  • Klodzko, Poland, 57-300
    • Globe Badania Kliniczne SP Z O.O.
  • Lublin, Poland, 20-582
    • Prywatny Gabinet Lekarski U.Chyrchel
  • Rzeszow, Poland, 35-055
    • Centrum Medyczne MEDYK
  • Szczecin, Poland, 70-111
    • Euromedis Sp. z o.o.
  • Torun, Poland, 87-100
    • Clinsante Centrum Medyczne
  • Warszawa, Poland, 01-697
    • Centrum Medyczne
  • Warszawa, Poland, 01-737
    • Specjalistyczny Osrodek Medycyny Wieku Dojrzalego SOMED
  • Dolnoslaskie
    • Wroclaw, Dolnoslaskie, Poland, 53 139
      • NZOZ Wroclawskie Centrum Alzheimerowskie
  • Podlaskie
    • Białystok, Podlaskie, Poland, 15-732
      • Podlaskie Centrum Psychogeriatrii
  • Pomorskie
    • Gdansk, Pomorskie, Poland, 80-952
      • Uniwersyteckie Centrum Kliniczne
• Portugal
  • Amadora, Portugal, 2700-351
    • Hospital Fernando Fonseca
  • Braga, Portugal, 4710-243
    • Hospital de Braga
  • Coimbra, Portugal, 3000-075
    • Hospitals da Universidade de Coimbra
• Russian Federation
  • Kazan, Russian Federation, 420064
    • SAIH Republ. Clinical Hospital of the MoH of Republ. Tatarst
  • Kemerovo, Russian Federation, 650066
    • SIH Kemerovo Regional Clinical Hosptial
  • Krasnoyarsk, Russian Federation, 660049
    • FSBIH Siberian Clinical Center of FMBA
  • Novosibirsk, Russian Federation, 630091
    • Novosibirsk State Medical University
  • Novosibirsk, Russian Federation, 630091
    • LLC City Neurological Centre Sibneuromed
  • Omsk, Russian Federation, 644024
    • Ultramed
  • Rostov-on-Don, Russian Federation, 344010
    • LLC Treatment and Rehabilitation
  • Smolensk, Russian Federation, 214018
    • RSBIH Smolensk Regional Clinical Hospital
  • St. Petersburg, Russian Federation, 192019
    • Bekhterev Psyconeurological Institute
  • St. Petersburg, Russian Federation, 194291
    • Central Medical Sanitary Hospital #122
  • Tomsk, Russian Federation, 634014
    • Regional State Institution of Healthcare Tomsk Clinica Psych
• Spain
  • Albacete, Spain, 02006
    • Hospital Ntra Sra Perpetuo Socorro
  • Barcelona, Spain, 08003
    • Hospital Del Mar
  • Barcelona, Spain, 08028
    • Fundacion ACE-Institut Catala de Neurociences Aplicades
  • Valencia, Spain, 46026
    • Hospital Universitario La Fe de Valencia
  • Alicante
    • San Vicente del Raspeig, Alicante, Spain, 03690
      • Hospital Cardiovascular San Vicente
  • Barcelona
    • Sant Cugat del Valles, Barcelona, Spain, 08190
      • Hospital General de Catalunya
    • Terrassa, Barcelona, Spain, 08221
      • Hospital Mútua de Terrassa
  • Caceres
    • Plasencia, Caceres, Spain, 10600
      • Hospital Virgen Del Puerto
  • Guipuzcoa
    • Donostia, Guipuzcoa, Spain, 20009
      • Policlinica Guipuzcoa
• Taiwan
  • Changhua, Taiwan, 500
    • Changhua Christian Hospital
  • Kaohsiung, Taiwan, 807
    • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Kaohsiung, Taiwan, 83301
    • Chang Gung Memorial Hospital - Kaohsiung
  • New Taipei, Taiwan, 23561
    • Taipei Medical University- Shuang Ho Hospital
  • Tainan, Taiwan, 704
    • National Cheng Kung University Hospital
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital
  • Taoyuan City, Taiwan, 33305
    • Chang Gung Memorial Hospital - Linkou
  • Taipei County
    • Sindian City, Taipei County, Taiwan, 23148
      • Cardinal Tien Hospital
  • Yunlin County
    • Douliu, Yunlin County, Taiwan, 640
      • National Taiwan University Hospital
• United Kingdom
  • Glasgow, United Kingdom, G20 0XA
    • Glasgow Memory Clinic
  • London, United Kingdom, W1G9JF
    • Re-Cognition Health Ltd
  • Devon
    • Exeter, Devon, United Kingdom, EX2 5DW
      • Royal Devon and Exeter Hospital
    • Plymouth, Devon, United Kingdom, PL6 8BT
      • Re-Cognition Health Ltd
  • Gloucestershire
    • Cheltenham, Gloucestershire, United Kingdom, GL53 9DZ
      • Charlton Lane Hospital
  • Surrey
    • Guildford, Surrey, United Kingdom, GU2 7YD
      • Re-Cognition Health Ltd
  • Tayside Region
    • Perth, Tayside Region, United Kingdom, PH2 7BH
      • Murray Royal Hospital
  • Wiltshire
    • Swindon, Wiltshire, United Kingdom, SN3 6BW
      • Victoria Centre
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • St Josephs Hospital and Medical Center
    • Phoenix, Arizona, United States, 85004
      • Xenoscience
    • Scottsdale, Arizona, United States, 85258
      • Four Peaks Neurology
    • Scottsdale, Arizona, United States, 85260
      • Arizona Neurology
    • Tucson, Arizona, United States, 85718
      • Center for Neurosciences
  • Arkansas
    • Jonesboro, Arkansas, United States, 72401
      • NEA Baptist Clinical
  • California
    • Carlsbad, California, United States, 92011
      • The Research Center of Southern California
    • Costa Mesa, California, United States, 92626
      • WCCT Global
    • Fresno, California, United States, 93710
      • Neuro-Pain Medical Center
    • Fullerton, California, United States, 92835
      • Neurology Center of North Orange County
    • Oxnard, California, United States, 93030
      • Pacific Neuroscience Medical Group
    • San Diego, California, United States, 92123
      • Sharp Mesa Vista Hospital
    • San Diego, California, United States, 92103
      • Pacific Research Network Inc
    • San Diego, California, United States, 92103-6204
      • California Research Foundation
    • Santa Ana, California, United States, 92705
      • Syrentis Clinical Research
    • Santa Clarita, California, United States, 91321
      • Care Access Research
    • Sherman Oaks, California, United States, 91403
      • California Neuroscience Research
    • Valencia, California, United States, 91355
      • Care Access Research
  • Connecticut
    • Danbury, Connecticut, United States, 06810
      • Associated Neurologists, PC - Danbury
    • New Haven, Connecticut, United States, 06510
      • Yale University School Of Medicine
    • New Haven, Connecticut, United States, 06510
      • Institute for Neurodegenerative Disorders
    • Norwalk, Connecticut, United States, 06851
      • Research Center for Clinical Studies, Inc
  • Florida
    • Atlantis, Florida, United States, 33462
      • JEM Research Institute
    • Clearwater, Florida, United States, 33755
      • Morton Plant Hospital
    • Delray Beach, Florida, United States, 33445
      • Brain Matters Research
    • Delray Beach, Florida, United States, 33446
      • Cohen Medical Associates P.A.
    • Fort Myers, Florida, United States, 33912
      • Neuropsychiatric Research Center of Southwest Florida
    • Hialeah, Florida, United States, 33012
      • Indago Research & Health Center, Inc.
    • Hollywood, Florida, United States, 33021
      • Infinity Clinical Research, LLC
    • Jacksonville, Florida, United States, 32216
      • Jacksonville Center for Clinical Research
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic-Jacksonville
    • Merritt Island, Florida, United States, 32955
      • Gregory A. Kirk MD LLC
    • Miami, Florida, United States, 33136
      • University of Miami
    • Miami, Florida, United States, 33155
      • Allied Biomedical Research Institute, Inc.
    • Orlando, Florida, United States, 32806
      • Compass Research
    • Pompano Beach, Florida, United States, 33064
      • Quantum Laboratories
    • Port Charlotte, Florida, United States, 33980
      • Charlotte Neurological Services
    • Sarasota, Florida, United States, 34239
      • Intercoastal Medical Group
    • Tampa, Florida, United States, 33609
      • Axiom Research
    • Tampa, Florida, United States, 33616
      • University of South Florida
  • Georgia
    • Atlanta, Georgia, United States, 30329
      • Emory University
    • Atlanta, Georgia, United States, 30331
      • Atlanta Center of Medical Research
    • Augusta, Georgia, United States, 30912
      • Georgia Regents University
    • Columbus, Georgia, United States, 31909
      • Medical Research Health and Education Foundation, Inc
  • Hawaii
    • Honolulu, Hawaii, United States, 96817
      • Hawaii Medical Center
  • Idaho
    • Meridian, Idaho, United States, 83642
      • Advanced Clinical Research LLC
  • Indiana
    • Avon, Indiana, United States, 46123
      • American Health Network
    • Indianapolis, Indiana, United States, 46256
      • Josephson Wallack Munshower Neurology
    • Muncie, Indiana, United States, 47304
      • American Health Network
  • Kansas
    • Fairway, Kansas, United States, 66160
      • University of Kansas Hospital
    • Topeka, Kansas, United States, 66606
      • Cotton O'Neil Clinic
    • Wichita, Kansas, United States, 67214
      • Via Christi Research, Inc.
  • Kentucky
    • Lexington, Kentucky, United States, 40513
      • Associates in Neurology, PSC
    • Lexington, Kentucky, United States, 40503
      • Baptist Health Medical Group
  • Maine
    • Bangor, Maine, United States, 04401
      • Eastern Maine Medical Center
    • Scarborough, Maine, United States, 04074
      • Maine Neurology
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston University Medical Center
    • Plymouth, Massachusetts, United States, 02360-4843
      • Donald S Marks
    • Winchester, Massachusetts, United States, 01890
      • Alzheimers Disease Center
  • Michigan
    • East Lansing, Michigan, United States, 48824
      • Michigan State University
  • Mississippi
    • Hattiesburg, Mississippi, United States, 39401
      • Hattiesburg Clinic
  • Missouri
    • Saint Louis, Missouri, United States, 63141
      • Clinical Research Professionals
  • Nevada
    • Las Vegas, Nevada, United States, 89113
      • Las Vegas Medical Research
  • New Jersey
    • Toms River, New Jersey, United States, 08755
      • Advanced Memory Research Institute of New Jersey
    • West Long Branch, New Jersey, United States, 07764
      • Neurology Specialists of Monmouth County
  • New York
    • New York, New York, United States, 10016
      • New York University Medical Center
  • North Carolina
    • Charlotte, North Carolina, United States, 28211
      • Behavioral Health Center Research
    • Raleigh, North Carolina, United States, 27607
      • Raleigh Neurology Associates
    • Winston-Salem, North Carolina, United States, 27103
      • PMG Research of Winston-Salem, LLC
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Univ CAR
  • Ohio
    • Cleveland, Ohio, United States, 44122
      • Rapid Medical Research Inc
    • Columbus, Ohio, United States, 43210
      • Ohio State University Medical Center
    • Shaker Heights, Ohio, United States, 44122
      • Insight Clinical Trials
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73116
      • Cutting Edge Research Group
    • Oklahoma City, Oklahoma, United States, 73112
      • Lynn Health Science Institute
  • Oregon
    • Corvallis, Oregon, United States, 97330
      • The Corvallis Clinic P.C.
    • Portland, Oregon, United States, 97210
      • Summit Research Network Inc
  • Pennsylvania
    • Jenkintown, Pennsylvania, United States, 19046
      • Clinical Trial Center, LLC, Psychiatry
    • Norristown, Pennsylvania, United States, 19401
      • Pearl Clinical Research Inc.
  • Rhode Island
    • East Providence, Rhode Island, United States, 02914
      • Rhode Island Mood & Memory Research Institute
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital
    • Providence, Rhode Island, United States, 02906
      • Butler Hospital
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
    • Greer, South Carolina, United States, 29650
      • Radiant Research
    • Port Royal, South Carolina, United States, 29935
      • Coastal Neurology PA
  • Tennessee
    • Kingsport, Tennessee, United States, 37660
      • Holston Medical Group Clinical Research
  • Texas
    • Fort Worth, Texas, United States, 76107
      • Univ of North Texas Health Science Center
    • San Antonio, Texas, United States, 78238
      • Texas Medical Research Associates, L.L.C.
  • Utah
    • Clinton, Utah, United States, 84015
      • Ericksen Research and Development
  • Wisconsin
    • Madison, Wisconsin, United States, 53715
      • SSM Health Dean Medical Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Significant and/or current 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, repetitive head trauma, serious infection of the brain, Parkinson's disease, epilepsy, or cervicocranial vascular disease.
• Participants with 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 assessment, or affect the participant's ability to complete the study. Participants with history of schizophrenia or other chronic psychosis are excluded.
• Within 1 year before the screening visit or between screening and randomization, any of the following: myocardial infarction; moderate or severe congestive heart failure, New York Heart Association class III or IV; hospitalization for, or symptoms of, unstable angina; syncope due to orthostatic hypotension or unexplained syncope; known significant structural heart disease (such as, significant valvular disease, hypertrophic cardiomyopathy); or hospitalization for arrhythmia.
• Congenital QT prolongation.
• Intermittent second- or third-degree atrioventricular (AV) heart block or AV dissociation or history of ventricular tachycardia.
• A corrected QT (QTcF) interval measurement >470 milliseconds (men and women) at screening (as determined at the investigational site).
• History of malignant cancer within the last 5 years.
• History of vitiligo and/or current evidence of post-inflammatory hypopigmentation.
• Calculated creatinine clearance <30 milliliters per minute (Cockcroft-Gault formula; Cockcroft and Gault 1976) at screening.
• Currently enrolled in any other clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lanabecestat 20 milligrams (mg); Participants received Lanabecestat 20 mg film-coated tablets orally once daily until week 156.	Drug: Lanabecestat; Administered orally; Other Names: LY3314814; AZD3293
Experimental: Lanabecestat 50 mg; Participants received Lanabecestat 50 mg film-coated tablets orally once daily until week 156.	Drug: Lanabecestat; Administered orally; Other Names: LY3314814; AZD3293
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.	Drug: Placebo; Administered orally; Drug: Lanabecestat; Administered orally; Other Names: LY3314814; AZD3293
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.	Drug: Placebo; Administered orally; Drug: Lanabecestat; Administered orally; Other Names: LY3314814; AZD3293

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog13) Score	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, acetylcholinesterase Inhibitor (AChEI) use at baseline, pooled site, and covariates for baseline ADAS-Cog13 total score, age at baseline, and baseline ADAS-Cog13 total score-by-visit interaction.	Baseline, Week 78

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Alzheimer´s Disease Cooperative Study Activities of Daily Living Inventory Instrumental Items Score (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, AChEI use at baseline, pooled site, and covariates for baseline iADL score, age at baseline, and baseline iADL score-by-visit interaction.	Baseline, Week 78
Change From Baseline in 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 determined by MMRM model with factors for treatment, visit, treatment-by-visit interaction, AChEI use at baseline, pooled site, and covariates for baseline FAQ total score, by-visit interaction and age at baseline.	Baseline, Week 78
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-by-visit interaction, AChEI use at baseline, pooled site, and covariates for baseline iADRS13 total score, age at baseline, and baseline iADRS13 total score-by-visit interaction.	Baseline, Week 78
Change From Baseline in the Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score	The CDR-SB is a rater administered scale and impairment is scored in each of 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, AChEI use at baseline, pooled site, and covariates for baseline CDR-SB score, age at baseline, and baseline CDR-SB score-by-visit interaction.	Baseline, Week 78
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).	From Loss of 1 Global Stage through Week 78
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 a greater severity of neuropsychiatric disturbance. LS Mean was determined by MMRM methodology with factors for treatment, visit, treatment-by-visit interaction, AChEI use at baseline, pooled site, and covariates for baseline NPI score, age at baseline, and baseline NPI score-by-visit interaction.	Baseline, Week 78
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, AChEI use at baseline, pooled site, and covariates for baseline MMSE total score, age at baseline, and baseline MMSE total score-by-visit interaction.	Baseline, Week 78
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.	Baseline, Week 71
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.	Baseline, Week 71
Change From Baseline in CSF Biomarker Total Tau	Cerebrospinal fluid samples were collected for analysis of concentration total tau. LS Mean was determined by ANCOVA with LOCF and with factors for treatment, baseline biomarker and age at baseline.	Baseline, Week 71
Change From Baseline in CSF Biomarker Phosphorylated Tau	Cerebrospinal fluid samples are collected for analysis of concentration of phosphorylated tau. LS Mean was determined by ANCOVA with LOCF and with factors for treatment, baseline biomarker and age at baseline.	Baseline, Week 71
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 using ANCOVA methodology with terms for treatment, baseline biomarker and age at baseline.	Baseline, Week 78
Change From Baseline in Regional Cerebral Blood Flow (rCBF) Using Florbetapir Perfusion Scan	Florbetapir perfusion evaluated the regional cerebral blood flow (rCBF) as a biomarker of brain function and was performed at the same time as the amyloid florbetapir PET. Cerebral perfusion, especially in temporal and parietal areas, is reduced in AD and this pattern of hypoperfusion closely mirrors the hypometabolism pattern observed using FDG PET. Annualized change is derived as change at LOCF divided by (LOCF date - baseline date) multiplied by 365. LS Mean was determined by ANCOVA with LOCF (last observation carried forward) and with factors for treatment, baseline biomarker and age at baseline.	Baseline, Week 78
Change From Baseline in Whole Brain Volume	Magnetic resonance imaging (MRI) was used to evaluate the effect of lanabecestat on brain atrophy/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 with LOCF and with factors for treatment, baseline volumetric magnetic resonance imaging (vMRI), intracranial volume and age at baseline.	Baseline, Week 78
Population Pharmacokinetics (PK): Apparent Oral Clearance of Lanabecestat	The apparent oral clearance of lanabecestat was estimated using a population approach. No covariate effects were assessed as part of this analysis.	Predose, Week 4, 7, 19, 39, 45 and Week 71 post dose
Population PK: Central Volume of Distribution of Lanabecestat	The central volume of distribution for lanabecestat was estimated using a population approach. No covariate effects were assessed as part of this analysis.	Predose, Week 4, 7, 19, 39, 45 and week 71 post dose

Collaborators and Investigators

• Sponsor: AstraZeneca
• Collaborators: Eli Lilly and Company

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• CSP
• SAP

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): September 28, 2018
• Study Completion (Actual): September 28, 2018

Study Registration Dates

• First Submitted: May 24, 2016
• First Submitted That Met QC Criteria: May 24, 2016
• First Posted (Estimate): May 26, 2016

Study Record Updates

• Last Update Posted (Actual): December 3, 2019
• Last Update Submitted That Met QC Criteria: November 19, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: memory; dementia; amyloid; nervous system diseases; brain diseases; mental disorders; central nervous system diseases; neurodegenerative diseases; tauopathies; delirium, dementia, amnestic, cognitive
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Tauopathies; Dementia; Alzheimer Disease
• Other Study ID Numbers: 16024; I8D-MC-AZET (Other Identifier: Eli Lilly and Company); 2015-005625-39 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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 Supporting Information Type: STUDY_PROTOCOL; SAP; CSR