Study Stopped
An independent assessment concluded the trial was not likely to meet the primary endpoint upon completion and therefore, trial stopped for futility.
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
3 other identifiers
interventional
1,722
18 countries
262
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2016
262 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 24, 2016
CompletedFirst Posted
Study publicly available on registry
May 26, 2016
CompletedStudy Start
First participant enrolled
July 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 28, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 28, 2018
CompletedResults Posted
Study results publicly available
August 6, 2019
CompletedDecember 3, 2019
October 1, 2019
2.2 years
May 24, 2016
June 11, 2019
November 19, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (16)
Change From Baseline in Alzheimer´s Disease Cooperative Study Activities of Daily Living Inventory Instrumental Items Score (ADCS-iADL)
Baseline, Week 78
Change From Baseline in Functional Activities Questionnaire (FAQ) Score
Baseline, Week 78
Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) Score
Baseline, Week 78
Change From Baseline in the Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score
Baseline, Week 78
Time to Progression as Measured by Loss of Clinical Dementia Rating (CDR) Global Score Stage
From Loss of 1 Global Stage through Week 78
- +11 more secondary outcomes
Study Arms (4)
Lanabecestat 20 milligrams (mg)
EXPERIMENTALParticipants received Lanabecestat 20 mg film-coated tablets orally once daily until week 156.
Lanabecestat 50 mg
EXPERIMENTALParticipants received Lanabecestat 50 mg film-coated tablets orally once daily until week 156.
Placebo/ Lanabecestat 20 mg
EXPERIMENTALPlacebo given orally once daily for 78 weeks and then 20 mg of lanabecestat given orally once daily until week 156.
Placebo/ Lanabecestat 50 mg
EXPERIMENTALPlacebo given orally once daily for 78 weeks and then 50 mg of lanabecestat given orally once daily until week 156.
Interventions
Administered orally
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Eli Lilly and Companycollaborator
Study Sites (262)
Xenoscience
Phoenix, Arizona, 85004, United States
St Josephs Hospital and Medical Center
Phoenix, Arizona, 85013, United States
Four Peaks Neurology
Scottsdale, Arizona, 85258, United States
Arizona Neurology
Scottsdale, Arizona, 85260, United States
Center for Neurosciences
Tucson, Arizona, 85718, United States
NEA Baptist Clinical
Jonesboro, Arkansas, 72401, United States
The Research Center of Southern California
Carlsbad, California, 92011, United States
WCCT Global
Costa Mesa, California, 92626, United States
Neuro-Pain Medical Center
Fresno, California, 93710, United States
Neurology Center of North Orange County
Fullerton, California, 92835, United States
Pacific Neuroscience Medical Group
Oxnard, California, 93030, United States
California Research Foundation
San Diego, California, 92103-6204, United States
Pacific Research Network Inc
San Diego, California, 92103, United States
Sharp Mesa Vista Hospital
San Diego, California, 92123, United States
Syrentis Clinical Research
Santa Ana, California, 92705, United States
Care Access Research
Santa Clarita, California, 91321, United States
California Neuroscience Research
Sherman Oaks, California, 91403, United States
Care Access Research
Valencia, California, 91355, United States
Associated Neurologists, PC - Danbury
Danbury, Connecticut, 06810, United States
Institute for Neurodegenerative Disorders
New Haven, Connecticut, 06510, United States
Yale University School of Medicine
New Haven, Connecticut, 06510, United States
Research Center for Clinical Studies, Inc
Norwalk, Connecticut, 06851, United States
JEM Research Institute
Atlantis, Florida, 33462, United States
Morton Plant Hospital
Clearwater, Florida, 33755, United States
Brain Matters Research
Delray Beach, Florida, 33445, United States
Cohen Medical Associates P.A.
Delray Beach, Florida, 33446, United States
Neuropsychiatric Research Center of Southwest Florida
Fort Myers, Florida, 33912, United States
Indago Research & Health Center, Inc.
Hialeah, Florida, 33012, United States
Infinity Clinical Research, LLC
Hollywood, Florida, 33021, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216, United States
Mayo Clinic-Jacksonville
Jacksonville, Florida, 32224, United States
Gregory A. Kirk MD LLC
Merritt Island, Florida, 32955, United States
University of Miami
Miami, Florida, 33136, United States
Allied Biomedical Research Institute, Inc.
Miami, Florida, 33155, United States
Compass Research
Orlando, Florida, 32806, United States
Quantum Laboratories
Pompano Beach, Florida, 33064, United States
Charlotte Neurological Services
Port Charlotte, Florida, 33980, United States
Intercoastal Medical Group
Sarasota, Florida, 34239, United States
Axiom Research
Tampa, Florida, 33609, United States
University of South Florida
Tampa, Florida, 33616, United States
Emory University
Atlanta, Georgia, 30329, United States
Atlanta Center of Medical Research
Atlanta, Georgia, 30331, United States
Georgia Regents University
Augusta, Georgia, 30912, United States
Medical Research Health and Education Foundation, Inc
Columbus, Georgia, 31909, United States
Hawaii Medical Center
Honolulu, Hawaii, 96817, United States
Advanced Clinical Research LLC
Meridian, Idaho, 83642, United States
American Health Network
Avon, Indiana, 46123, United States
Josephson Wallack Munshower Neurology
Indianapolis, Indiana, 46256, United States
American Health Network
Muncie, Indiana, 47304, United States
University of Kansas Hospital
Fairway, Kansas, 66160, United States
Cotton O'Neil Clinic
Topeka, Kansas, 66606, United States
Via Christi Research, Inc.
Wichita, Kansas, 67214, United States
Baptist Health Medical Group
Lexington, Kentucky, 40503, United States
Associates in Neurology, PSC
Lexington, Kentucky, 40513, United States
Eastern Maine Medical Center
Bangor, Maine, 04401, United States
Maine Neurology
Scarborough, Maine, 04074, United States
Boston University Medical Center
Boston, Massachusetts, 02118, United States
Donald S Marks
Plymouth, Massachusetts, 02360-4843, United States
Alzheimers Disease Center
Winchester, Massachusetts, 01890, United States
Michigan State University
East Lansing, Michigan, 48824, United States
Hattiesburg Clinic
Hattiesburg, Mississippi, 39401, United States
Clinical Research Professionals
St Louis, Missouri, 63141, United States
Las Vegas Medical Research
Las Vegas, Nevada, 89113, United States
Advanced Memory Research Institute of New Jersey
Toms River, New Jersey, 08755, United States
Neurology Specialists of Monmouth County
West Long Branch, New Jersey, 07764, United States
New York University Medical Center
New York, New York, 10016, United States
Behavioral Health Center Research
Charlotte, North Carolina, 28211, United States
Raleigh Neurology Associates
Raleigh, North Carolina, 27607, United States
PMG Research of Winston-Salem, LLC
Winston-Salem, North Carolina, 27103, United States
Wake Forest Baptist Univ CAR
Winston-Salem, North Carolina, 27157, United States
Rapid Medical Research Inc
Cleveland, Ohio, 44122, United States
Ohio State University Medical Center
Columbus, Ohio, 43210, United States
Insight Clinical Trials
Shaker Heights, Ohio, 44122, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112, United States
Cutting Edge Research Group
Oklahoma City, Oklahoma, 73116, United States
The Corvallis Clinic P.C.
Corvallis, Oregon, 97330, United States
Summit Research Network Inc
Portland, Oregon, 97210, United States
Clinical Trial Center, LLC, Psychiatry
Jenkintown, Pennsylvania, 19046, United States
Pearl Clinical Research Inc.
Norristown, Pennsylvania, 19401, United States
Rhode Island Mood & Memory Research Institute
East Providence, Rhode Island, 02914, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Butler Hospital
Providence, Rhode Island, 02906, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Radiant Research
Greer, South Carolina, 29650, United States
Coastal Neurology PA
Port Royal, South Carolina, 29935, United States
Holston Medical Group Clinical Research
Kingsport, Tennessee, 37660, United States
Univ of North Texas Health Science Center
Fort Worth, Texas, 76107, United States
Texas Medical Research Associates, L.L.C.
San Antonio, Texas, 78238, United States
Ericksen Research and Development
Clinton, Utah, 84015, United States
SSM Health Dean Medical Group
Madison, Wisconsin, 53715, United States
University of Calgary
Calgary, Alberta, T2N 426, Canada
The Medical Arts Health Research Group
West Vancouver, British Columbia, V7T223, Canada
True North Clinical Research Halifax, LLC
Halifax, Nova Scotia, B3S1M7, Canada
Bruyere Continuing Care
Ottawa, Ontario, K1N 5C8, Canada
Kawartha Regional Memory Clinic
Peterborough, Ontario, K9H2P4, Canada
Toronto Memory Program
Toronto, Ontario, M3B2S7, Canada
Toronto Sunnybrook Regional Cancer Center
Toronto, Ontario, M4N 3M5, Canada
CSSS-Institut Universitaire Gériatric de Sherbrooke
Sherbrooke, Qubec, J1J3H5, Canada
Recherches Neuro-Hippocampe Inc
Gatineau, Quebec, J8T 8J1, Canada
Q&T Research Sherbrooke Inc
Sherbrooke, Quebec, J1J 2G2, Canada
Douglas Hospital and Research Centre
Verdun, Quebec, H4H 1R3, Canada
Xuanwu Hospital-Capital Medical University
Beijing, Beijing Municipality, 100053, China
Beijing 301 Hospital
Beijing, Beijing Municipality, 100853, China
Guangzhou First People's Hospital
Guangzhou, Guangdong, 510180, China
Tangshan Worker Hospital
Tangshan, Hebei, 063000, China
Nanjing Drum Tower Hosp Affiliated Hosp of Nanjing Univ Med
Nanjing, Jiangsu, 210008, China
Zhongda Hospital-Southeast University
Nanjing, Jiangsu, 210009, China
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, 225001, China
Qingdao Municipal Hospital
Qingdao, Shandong, 266071, China
Shanghai Tongji Hospital(CCBR site)
Shanghai, Shanghai Municipality, 200065, China
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041, China
The First Affiliated Hospital, Zhejiang University
Hangzhou, Zhejiang, 310003, China
The First Affiliated Hospital of Wenzhou Medical College
Wenzhou, Zhejiang, 325035, China
Shanghai Huashan Hospital Affil to Fu Dan University
Shanghai, 200040, China
Fakultni nemocnice u sv. Anny v Brne
Brno, 65691, Czechia
Neurohk s.r.o.
Choceň, 565 01, Czechia
Neuropsychiatrie s.r.o
Hradec Králové, 50009, Czechia
Brain-Soultherapy s.r.o
Kladno, 27201, Czechia
A-Shine s.r.o.
Pilsen, 31200, Czechia
Clintrial, s.r.o.
Prague, 100 00, Czechia
Neuropsychiatrie s.r.o
Prague, 160 00, Czechia
Medical Services Prague s.r.o.
Prague, 16000, Czechia
Axon Clinical, s.r.o.
Prague, 182 00, Czechia
CCBR-Alborg-DK
Aalborg, 9100, Denmark
Center For Clinical and Basic Research
Ballerup Municipality, 2750, Denmark
Rigshospitalet
Copenhagen, 2100 CPH, Denmark
Center for Clinical and Basic Research -CCBR
Vejle, 7100, Denmark
Institut Claude Pompidou - CMRR
Nice, Alpes Maritimes, 06100, France
CHU Rennes/Hopital Sud
Rennes, Ille Et Vilaine, 35064, France
Chu De Nancy Hop D'Adultes De Brabois
Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54511, France
CHU Saint Etienne - Hopital Nord
Saint Priest En Jarez, Pays de la Loire Region, 42270, France
CHU d'Amiens-Picardie Hopital Sud
Amiens, 80054, France
CHU de Caen Hopital Cote de Nacre
Caen, 14033, France
APHM Hôpital de la Timone
Marseille, 13385, France
Hôpital de la Pitié-Salpêtrière
Paris, 75013, France
CHU Strasbourg Hôpital de Hautepierre
Strasbourg, 67098, France
Chu de Toulouse Hopital de La Grave
Toulouse, 31059, France
Praxis Dr. Erich Scholz
Böblingen, Baden-Wurttemberg, 71034, Germany
ISPG - Institut für Studien zur psychischen Gesundheit
Mannheim, Baden-Wurttemberg, 68165, Germany
Praxis für Neurologie und Psychiatrie Dr. med. Roth
Ostfildern, Baden-Wurttemberg, 73760, Germany
Neurozentrum Sophienstraße
Stuttgart, Baden-Wurttemberg, 70178, Germany
Klinikum der Universität München
München, Bavaria, 81377, Germany
Klinikum Rechts der Isar der TU München
München, Bavaria, 81675, Germany
Neuropraxis München Süd
Unterhaching, Bavaria, 82008, Germany
Diakoniekrankenhaus Henriettenstiftung Hannover
Hanover, Lower Saxony, 30559, Germany
MVZ LiO Berlin
Berlin, 12209, Germany
Policlinico Univ. Agostino Gemelli
Rome, Lazio, 00168, Italy
Spedali Civili - Universita degli Studi
Brescia, 25123, Italy
Azienda Ospedaliera Universitaria Careggi
Florence, 50134, Italy
Ente Ospedaliero Ospedali Galliera
Genova, 16128, Italy
IRCCS Azienda Ospedaliera Universitaria San Martino
Genova, 16132, Italy
SDN - Istituto di Ricerca Diagnostica e Nucleare
Napoli, 80143, Italy
Azienda Ospedaliera - Universitaria Pisana
Pisa, 56126, Italy
IRCCS Santa Lucia
Roma, 00179, Italy
Universita La Sapienza
Roma, 00185, Italy
Azienda Ospedaliera Citta della Salute della Scienza Torino
Torino, 10126, Italy
Shinwakai Yachiyo Hospital
Anjo-shi, Aichi-ken, 446-8510, Japan
Nagoya Ekisaikai Hospital
Nagoya, Aichi-ken, 454-8502, Japan
Kojunkai Daido Hospital
Nagoya, Aichi-ken, 457-8511, Japan
Inage Neurology and Memory Clinic
Chiba, Chiba, 263-0043, Japan
Ehime University Hospital
Toon-Shi, Ehime, 791-0295, Japan
Takeda General Hospital
Aizu-Wakamatsu, Fukushima, 965-8585, Japan
Jisenkai Nanko Psychiatric Institute
Shirakawa-shi, Fukushima, 961-0021, Japan
Koseikai Kusatsu Hospital
Hiroshima, Hiroshima, 733-0864, Japan
NHO Hiroshima-Nishi Medical Center
Otaki-Shi, Hiroshima, 739-0696, Japan
Yokohama Hospital
Yokohama, Kanagawa, 221-0801, Japan
Koseikai Takeda Hospital
Kyoto, Kyoto, 600-8558, Japan
Uji Takeda Hospital
Uji-Shi, Kyoto, 611-0021, Japan
Nara Medical University Hospital
Kashihara, Nara, 634-8522, Japan
JADECOM Nara City Hospital
Nara, Nara, 630-8305, Japan
Oita University Hospital
Yufu-shi, Oita Prefecture, 879-5593, Japan
Katayama Medical Clinic
Kurashiki-shi, Okayama-ken, 710-0813, Japan
Himuro Neurology Clinic
Osaka, Osaka, 534-0021, Japan
Kotobukikai Tominaga Clinic
Osaka, Osaka, 556-0015, Japan
Kousaiin Hospital
Suita-shi, Osaka, 565-0874, Japan
NHO Hizen Psychiatric Center
Kanzaki-gun, Saga-ken, 842-0192, Japan
Shimizu Hospital
Shizuoka, Shizuoka, 424-8636, Japan
Memory Clinic Ochanomizu
Bunkyo-ku, Tokyo, 113-0034, Japan
Juntendo University Hospital
Bunkyo-ku, Tokyo, 113-8431, Japan
Musashino Red Cross Hospital
Musashino, Tokyo, 180-8610, Japan
Keikokai P-One Clinic
Hachioji-shi, Tokyo-To, 192-0071, Japan
JOHAS Sanin Rosai Hospital
Yonago-shi, Tottori, 683-8605, Japan
Aomori Prefectural Centeral Hospital
Aomori, 030-8553, Japan
Ikeuchi Psycho Induced Internal Clinic
Kobe, 655-0037, Japan
Yuge Hospital
Kumamoto, 861-8002, Japan
NHO Niigata Hospital
Niigata, 945-8585, Japan
NHO Hokkaido Medical Center
Sapporo, 063-0005, Japan
Hospital Universitario de Saltillo
Saltillo, Coahuila, 25000, Mexico
Clinical Research Institute S C
Tlalnepantla, Edo de Mex, 54055, Mexico
Mexico Centre for Clinical Research SA de CV
Mexico City, Mexico City, 03100, Mexico
Hospital Univ. Jose Eleuterio Gonzalez
Monterrey, N.L., 64460, Mexico
Accelerium Clinical Research
Monterrey, Nuevo León, 64000, Mexico
Centro de Estudios Clinicos y Esp Medicas SC
Monterrey, Nuevo León, 64620, Mexico
Avix Investigación Clínica, S.C
Monterrey, Nuevo León, 64710, Mexico
Instituto de Informacion en Salud Mental (INFOSAM)
Monterrey, Nuevo León, 64710, Mexico
Emotional Brain B.V.
Almere Stad, 1311 RL, Netherlands
Brain Research Center
Amsterdam, 1081 GM, Netherlands
Amphia Ziekenhuis
Breda, 4818 CK, Netherlands
EB Utrecht
Utrecht, 3511 NH, Netherlands
Isala Klinieken
Zwolle, 8025 AB, Netherlands
NZOZ Wroclawskie Centrum Alzheimerowskie
Wroclaw, Lower Silesian Voivodeship, 53 139, Poland
Podlaskie Centrum Psychogeriatrii
Bialystok, Podlaskie Voivodeship, 15-732, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, Pomeranian Voivodeship, 80-952, Poland
NZOZ Mach-Med
Chorzów, 41-506, Poland
Klinika Neurologii Neuro-Care
Katowice, 40749, Poland
Globe Badania Kliniczne SP Z O.O.
Kłodzko, 57-300, Poland
Prywatny Gabinet Lekarski U.Chyrchel
Lublin, 20-582, Poland
Centrum Medyczne Medyk
Rzeszów, 35-055, Poland
Euromedis Sp. z o.o.
Szczecin, 70-111, Poland
Clinsante Centrum Medyczne
Torun, 87-100, Poland
Centrum Medyczne
Warsaw, 01-697, Poland
Specjalistyczny Osrodek Medycyny Wieku Dojrzalego SOMED
Warsaw, 01-737, Poland
Hospital Fernando Fonseca
Amadora, 2700-351, Portugal
Hospital de Braga
Braga, 4710-243, Portugal
Hospitals da Universidade de Coimbra
Coimbra, 3000-075, Portugal
SAIH Republ. Clinical Hospital of the MoH of Republ. Tatarst
Kazan', 420064, Russia
SIH Kemerovo Regional Clinical Hosptial
Kemerovo, 650066, Russia
FSBIH Siberian Clinical Center of FMBA
Krasnoyarsk, 660049, Russia
LLC City Neurological Centre Sibneuromed
Novosibirsk, 630091, Russia
Novosibirsk State Medical University
Novosibirsk, 630091, Russia
Ultramed
Omsk, 644024, Russia
LLC Treatment and Rehabilitation
Rostov-on-Don, 344010, Russia
Bekhterev Psyconeurological Institute
Saint Petersburg, 192019, Russia
Central Medical Sanitary Hospital #122
Saint Petersburg, 194291, Russia
RSBIH Smolensk Regional Clinical Hospital
Smolensk, 214018, Russia
Regional State Institution of Healthcare Tomsk Clinica Psych
Tomsk, 634014, Russia
Dong-A University Medical Center
Busan, Busan Gwang'yeogsi, 49201, South Korea
The Catholic University of Korea-Bucheon St. Mary's Hospital
Bucheon-si, Gyeonggi-do, 14647, South Korea
Myongji Hospital
Goyang-si, Gyeonggi-do, 13620, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620, South Korea
Inha University Hospital
Incheon, 22332, South Korea
Korea University Anam Hospital
Seoul, 02841, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Hanyang University Medical Center
Seoul, 04763, South Korea
Konkuk University Hospital
Seoul, 05030, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Hospital Cardiovascular San Vicente
San Vicent del Raspeig, Alicante, 03690, Spain
Hospital General de Catalunya
Sant Cugat del Vallès, Barcelona, 08190, Spain
Hospital Mutua de Terrassa
Terrassa, Barcelona, 08221, Spain
Hospital Virgen Del Puerto
Plasencia, Caceres, 10600, Spain
Policlinica Guipuzcoa
Donostia / San Sebastian, Guipuzcoa, 20009, Spain
Hospital Ntra Sra Perpetuo Socorro
Albacete, 02006, Spain
Hospital del Mar
Barcelona, 08003, Spain
Fundacion ACE-Institut Catala de Neurociences Aplicades
Barcelona, 08028, Spain
Hospital Universitario La Fe de Valencia
Valencia, 46026, Spain
Cardinal Tien Hospital
Sindian City, Taipei, 23148, Taiwan
National Taiwan University Hospital
Douliu, Yunlin County, 640, Taiwan
Changhua Christian Hospital
Changhua, 500, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807, Taiwan
Chang Gung Memorial Hospital - Kaohsiung
Kaohsiung City, 83301, Taiwan
Taipei Medical University- Shuang Ho Hospital
New Taipei City, 23561, Taiwan
National Cheng Kung University Hospital
Tainan, 704, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Chang Gung Memorial Hospital - Linkou
Taoyuan, 33305, Taiwan
Royal Devon and Exeter Hospital
Exeter, Devon, EX2 5DW, United Kingdom
Re-Cognition Health Ltd
Plymouth, Devon, PL6 8BT, United Kingdom
Charlton Lane Hospital
Cheltenham, Gloucestershire, GL53 9DZ, United Kingdom
Re-Cognition Health Ltd
Guildford, Surrey, GU2 7YD, United Kingdom
Murray Royal Hospital
Perth, Tayside Region, PH2 7BH, United Kingdom
Victoria Centre
Swindon, Wiltshire, SN3 6BW, United Kingdom
Glasgow Memory Clinic
Glasgow, G20 0XA, United Kingdom
Re-Cognition Health Ltd
London, W1G9JF, United Kingdom
Related Publications (2)
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.
PMID: 31764959DERIVEDCebers 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.
PMID: 27767991DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
An independent assessment concluded the trial was not likely to meet the primary endpoint upon completion and therefore, trial stopped for futility.
Results Point of Contact
- Title
- AstraZeneca Information Center
- Organization
- AstraZeneca
Study Officials
- STUDY DIRECTOR
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)
Eli Lilly and Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 24, 2016
First Posted
May 26, 2016
Study Start
July 1, 2016
Primary Completion
September 28, 2018
Study Completion
September 28, 2018
Last Updated
December 3, 2019
Results First Posted
August 6, 2019
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- 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.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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.