Study Stopped
An independent assessment concluded the trial was not likely to meet the primary endpoint upon completion and therefore, trial stopped for futility
An Efficacy and Safety Study of Lanabecestat (LY3314814) in Early Alzheimer's Disease
AMARANTH
A 24-month, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Efficacy, Safety, Tolerability, Biomarker, and Pharmacokinetic Study of AZD3293 in Early Alzheimer's Disease (The AMARANTH Study)
4 other identifiers
interventional
2,218
15 countries
254
Brief Summary
The purpose of this study is to assess the efficacy and safety of lanabecestat compared with placebo administered for 104 weeks in the treatment of early Alzheimer´s disease. The study will test the hypothesis that lanabecestat is a disease-modifying treatment for participants with early Alzheimer´s disease, defined as the continuum of participants with mild cognitive impairment (MCI) due to Alzheimer´s disease and participants diagnosed with mild dementia of the Alzheimer´s type, as measured by change from baseline on the 13-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) score at week 104 in each of the 2 lanabecestat treatment groups compared with placebo.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2014
Typical duration for phase_2
254 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
September 18, 2014
CompletedFirst Posted
Study publicly available on registry
September 22, 2014
CompletedStudy Start
First participant enrolled
September 30, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 4, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 4, 2018
CompletedResults Posted
Study results publicly available
August 6, 2019
CompletedDecember 3, 2019
October 1, 2019
4 years
September 18, 2014
June 11, 2019
November 19, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline on the 13-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13)
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, disease status at baseline, apolipoprotein E4 (APOE4) status, acetylcholinesterase inhibitor (AChEI) use at baseline, pooled country, and covariates for baseline ADAS-Cog13 total score, age at baseline, and baseline ADAS-Cog13 total score-by-visit interaction.
Baseline, Week 104
Secondary Outcomes (16)
Change From Baseline on the Alzheimer´s Disease Cooperative Study Activities of Daily Living Inventory Instrumental Items (ADCS-iADL)
Baseline, Week 104
Change From Baseline on the Functional Activities Questionnaire (FAQ) Score
Baseline, Week 104
Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) Score
Baseline, Week 104
Change From Baseline on the Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score
Baseline, Week 104
Time to Progression as Measured by Loss of Clinical Dementia Rating (CDR) Global Score Stage
Baseline through Loss of 1 Global Stage or Week 104
- +11 more secondary outcomes
Study Arms (3)
Lanabecestat 20 milligrams (mg)
EXPERIMENTALLanabecestat 20 mg given orally once daily for 104 weeks.
Lanabecestat 50 mg
EXPERIMENTALLanabecestat 50 mg given orally once daily for 104 weeks.
Placebo
PLACEBO COMPARATORPlacebo given orally once daily for 104 weeks.
Interventions
Administered orally
Eligibility Criteria
You may qualify if:
- Gradual and progressive change in the participant's memory function over more than 6 months, reported by participant and study partner
- Mini-Mental State Examination score of 20-30 inclusive at screening
- Objective impairment in memory as evaluated by memory test performed at screening
- For a diagnosis of mild Alzheimer's Disease (AD), participant meets the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria for probable AD
- For a diagnosis of MCI due to AD, participant meets NIA-AA criteria for MCI due to AD
You may not qualify if:
- Significant 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, serious infection of the brain, Parkinson´s disease, or epilepsy or recurrent seizures
- History of clinically evident stroke, or multiple strokes based on history or imaging results
- History of clinically important carotid or vertebrobasilar stenosis or plaque
- History of multiple concussions with sustained cognitive complaints or objective change in neuropsychological function in the last 5 years
- Participants with a current Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition diagnosis of Major Depressive Disorder or 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 assessments, or affect the participant´s ability to complete the study
- History of alcohol or drug abuse or dependence (except nicotine dependence) within 2 years before the screening
- Within 1 year before the screening or between screening and baseline, any of the following: myocardial infarction; moderate or severe congestive heart failure, New York Heart Association class III or IV; hospitalization for, or symptom of, unstable angina; syncope due to orthostatic hypotension or unexplained syncope; known significant structural heart disease (eg, significant valvular disease, hypertrophic cardiomyopathy), or hospitalization for arrhythmia
- Congenital QT prolongation
- History of cancer within the last 5 years, with the exception of non-metastatic basal and/or squamous cell carcinoma of the skin, in situ cervical cancer, non-progressive prostate cancer or other cancers with low-risk of recurrence or spread
- Current serious or unstable clinically important systemic illness that, in the judgment of the investigator, is likely to affect cognitive assessment, deteriorate, or affect the participant's safety or ability to complete the study, including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic, or hematologic disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Eli Lilly and Companycollaborator
Study Sites (254)
Banner Alzheimer's Institute
Phoenix, Arizona, 85006, United States
St Josephs Hospital and Medical Center
Phoenix, Arizona, 85013, United States
Banner Sun Health Research Institute
Sun City, Arizona, 85351, United States
Territory Neurology & Research Institute
Tucson, Arizona, 85704, United States
Positron Research International
Fremont, California, 94538, United States
Alliance Research Centers
Laguna Hills, California, 92653, United States
Senior Clinical Trials, Inc.
Laguna Hills, California, 92653, United States
Collaborative Neuroscience Network - CNS
Long Beach, California, 90806, United States
Pacific Research Network Inc
San Diego, California, 92103, United States
San Francisco Clinical Research Center
San Francisco, California, 94109, United States
Mile High Research Center
Denver, Colorado, 80218, United States
Institute for Neurodegenerative Disorders
New Haven, Connecticut, 06510, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, 20057, United States
Brain Matters Research
Delray Beach, Florida, 33445, United States
Direct Helpers Medical Center
Hialeah, Florida, 33012, United States
Berma Research
Hialeah, Florida, 33016, United States
Galiz Research
Hialeah, Florida, 33016, United States
MaxBlue Institute
Hialeah, Florida, 33018, United States
Alzheimer's Research and Treatment Center
Lake Worth, Florida, 33449, United States
Miami Jewish Health Systems
Miami, Florida, 33137, United States
Medical Research Center
Miami, Florida, 33144, United States
Allied Biomedical Research Institute, Inc.
Miami, Florida, 33155, United States
Advance Medical Research Institute
Miami, Florida, 33174, United States
New Horizon Research Center
Miami, Florida, 33175, United States
JDH Medical Group, LLC
Miami, Florida, 33186, United States
Compass Research
Orlando, Florida, 32806, United States
IMIC, Inc.
Palmetto Bay, Florida, 33157, United States
Roskamp Institute
Sarasota, Florida, 34243, United States
Suncoast Neuroscience Associates
St. Petersburg, Florida, 33713, United States
Infinity Clinical Research, LLC
Sunrise, Florida, 33351, United States
Stedman Clinical Trials
Tampa, Florida, 33613, United States
Olympian Clinical Research
Tampa, Florida, 33614, United States
Compass Research
The Villages, Florida, 32162, United States
Premiere Research Institute at Palm Beach Neurology
West Palm Beach, Florida, 33407, United States
The Multiple Sclerosis Center of Atlanta
Atlanta, Georgia, 30327, United States
Atlanta Center of Medical Research
Atlanta, Georgia, 30331, United States
Carman Research
Smyrna, Georgia, 30080, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Alexian Brothers Medical Center
Elk Grove Village, Illinois, 60007, United States
Community Clinical Research Center
Anderson, Indiana, 46011, United States
Indiana University School of Medicine
Indianapolis, Indiana, 46202, United States
ActivMed Practices & Research, Inc
Methuen, Massachusetts, 01844, United States
Boston Center for Memory
Newton, Massachusetts, 02459, United States
Springfield Neurology Associates
Springfield, Massachusetts, 01104, United States
Hattiesburg Clinic
Hattiesburg, Mississippi, 39401, United States
Millennium Psychiatric Associates, LLV
St Louis, Missouri, 63141, United States
St. Louis Clinical Trials, LC
St Louis, Missouri, 63141, United States
Memory Enhancement Center of America, Inc.
Eatontown, New Jersey, 07724, United States
AdvanceMed Research
Lawrenceville, New Jersey, 08648, United States
Alzheimer's Research Company
Paterson, New Jersey, 08759, United States
The Cognitive and Research Center of NJ
Springfield, New Jersey, 07081, United States
Advanced Memory Research Institute of New Jersey
Toms River, New Jersey, 08755, United States
Bio Behavioral Health
Toms River, New Jersey, 08755, United States
Neurology Specialists of Monmouth County
West Long Branch, New Jersey, 07764, United States
Integrative Clinical Trials, LLC
Brooklyn, New York, 11229, United States
SPRI Clinical Trials, LLC.
Brooklyn, New York, 11235, United States
Alzheimer's Disease and Memory Disorders Center
Buffalo, New York, 14203, United States
Empire Neurology, PC
Latham, New York, 12110, United States
Clinilabs, Inc (New York)
New York, New York, 10019, United States
Columbia University Medical Center
New York, New York, 10032, United States
University of Rochester
Rochester, New York, 14620, United States
Alzheimer's Memory Center
Charlotte, North Carolina, 28270, United States
Valley Medical Primary Care
Centerville, Ohio, 45459, United States
Christ Hospital
Cincinnati, Ohio, 45219, United States
Ohio State University Medical Center
Columbus, Ohio, 43221, United States
The Corvallis Clinic P.C.
Corvallis, Oregon, 97330, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, 18103, United States
Rhode Island Mood & Memory Research Institute
East Providence, Rhode Island, 02914, United States
Roper St. Francis Healthcare
Charleston, South Carolina, 29401, United States
Radiant Research
Greer, South Carolina, 29651, United States
Quillen College of Medicine, East TN State University
Johnson City, Tennessee, 37605, United States
Senior Adults Specialty Research Inc
Austin, Texas, 78757, United States
Texas Health Physicians Group
Dallas, Texas, 75231, United States
Medical Group of Texas
Fort Worth, Texas, 76104, United States
University of Texas Health Services Center - Houston
Houston, Texas, 77054, United States
University of Utah School of Medicine
Salt Lake City, Utah, 84108, United States
The Memory Clinic
Bennington, Vermont, 05201, United States
Southern Neurology
Kogarah, New South Wales, 2217, Australia
Griffith University
Gold Coast, Queensland, 4222, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Box Hill Hospital
Box Hill, Victoria, 3128, Australia
Delmont Private Hospital
Glen Iris, Victoria, 3146, Australia
Heidelberg Repatriation Hospital
Heidelberg, Victoria, 3081, Australia
The Florey Institute of Neuroscience and Mental Health
Parkville, Victoria, 3052, Australia
Australian Alzheimer's Research Foundation
Nedlands, Western Australia, 6009, Australia
Neuro Trials Victoria Pty Ltd
Noble Park, 3174, Australia
Jessa Ziekenhuis
Hasselt, Limburg, 3500, Belgium
Hopital Universitaire Brugmann Brussel
Brussels, 1020, Belgium
Hospital Universitaire Erasme Brussel
Brussels, 1070, Belgium
Cliniques Universitaires Saint-Luc
Brussels, 1200, Belgium
Universitair Ziekenhuis Antwerpen
Edegem, 2650, Belgium
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
Leuven, 3000, Belgium
Heilig Hartziekenhuis
Roeselare, 8800, Belgium
The Medical Arts Health Research Group
Kamloops, British Columbia, V2C 1K7, Canada
Okanagan Clinical Trials
Kelowna, British Columbia, V1Y 1Z9, Canada
University of British Columbia
Vancouver, British Columbia, V6T 2B5, Canada
Royal Jubilee Hospital
Victoria, British Columbia, V8R 158, 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 Western Hospital
Toronto, Ontario, M5T2S8, Canada
CSSS-Institut Universitaire Gériatric de Sherbrooke
Sherbrooke, Qubec, J1J3H5, Canada
Clinique de la Memoire de l'Outaouais
Gatineau, Quebec, J8T 8J1, Canada
NeuroSearch Developements
Greenfield Park, Quebec, J4V 2J2, Canada
Hopital Maisonneure-Rosemount
Montreal, Quebec, H1T 2M4, Canada
Hopital de L'Enfant Jesus
Québec, Quebec, G1J 1Z4, Canada
Q&T Research Sherbrooke Inc
Sherbrooke, Quebec, J1J 2G2, Canada
CHU de Toulouse Hopital Purpan
Toulouse, Cedex 9, 31059, France
Hopital Neuro Pierre Wertheimer
Bron, 69677, France
CHU Dijonon
Dijon, 21033, France
CHRU Lille - Hopital Roger Salengro
Lille, 59037, France
CHU Hopital de la Timone
Marseille, 13385, France
Chu de Nantes Hopital Laennec
Nantes, 44093, France
Hopital Broca
Paris, 75013, France
Hopital de la Pitie Salpetriere
Paris, 75013, France
Hopital Lariboisière
Paris, 75475, France
CHU de Toulouse
Toulouse, 31052, France
Hopital des Charpennes
Villeurbanne, 69100, France
Universitätsklinikum Tübingen
Tübingen, Baden-Wurttemberg, 72076, Germany
Universitätsklinikum Ulm
Ulm, Baden-Wurttemberg, 89081, Germany
Studien und Gedächtniszentrum München
München, Bavaria, 80331, Germany
Klinikum Rechts der Isar der TU München
München, Bavaria, 81675, Germany
Institut fur Psychogerontologie
Nuremberg, Bavaria, 90402, Germany
Neurozentrum Prien
Prien am Chiemsee, Bavaria, 83209, Germany
Institut für Neuropsychiatrie INP3
Wenzenbach, Bavaria, 93173, Germany
Studienzentrum Nord-West
Westerstede, Lower Saxony, 26655, Germany
Praxis Dr. Lauter
Bochum, North Rhine-Westphalia, 44787, Germany
St Josef-Hospital Bochum
Bochum, North Rhine-Westphalia, 44791, Germany
Universitätsklinikum Bonn
Bonn, North Rhine-Westphalia, 53105, Germany
Gemeinschaftspraxis für Neurologie Prof. Gereon Nelles
Cologne, North Rhine-Westphalia, 50935, Germany
Universitätsklinikum Köln
Cologne, North Rhine-Westphalia, 50937, Germany
Neurologische Praxis Siegen
Siegen, North Rhine-Westphalia, 57076, Germany
Universitätsklinikum des Saarlandes
Homburg, Saarland, 66421, Germany
Pharmakologisches Studienzentrum Chemnitz
Mittweida, Saxony, 09648, Germany
Martin-Luther-Universität Halle-Wittenberg
Halle, Saxony-Anhalt, 06097, Germany
Universitätsklinikum Otto-von-Guericke-Universität
Magdeburg, Saxony-Anhalt, 39120, Germany
Arztpraxis Dr. Christian Oehlwein
Gera, Thuringia, 07551, Germany
Gemeinschaftspraxis Dr. R. Ehret & Dr. W. von Pannwitz
Berlin, 12163, Germany
Charité Universitätsmedizin Berlin
Berlin, 12203, Germany
Charité Universitätsmedizin Berlin
Berlin, 13353, Germany
PTE KK Pszichiatriai es Pszichoterapias Klinika
Pécs, Baranya, 7623, Hungary
Semmelweis Medical University
Budapest, 1083, Hungary
Del-pesti Centrumkorház - Orszagos Hematologiai és Infektologiai Intezet
Budapest, 1097, Hungary
Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz
Debrecen, 4031, Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032, Hungary
Univerisity of Szeged
Szeged, 6725, Hungary
Ospedale Degli Infermi ASR USSL 12
Ponderano, Biella, 13875, Italy
Azienda Ospedaliera San Gerardo
Monza, Milano, 20900, Italy
Fondazione San Raffaele Giglio di Cefalu
Cefalù, Palermo, 90015, Italy
Universita Di Pisa
Pisa, PI, 56126, Italy
Università Politecnica delle Marche Torrette
Ancona, 60126, Italy
IRCCS San Giovanni di Dio Fatebenefratelli
Brescia, 25125, Italy
Fondazione Universitaria degli Studi G D'Annunzio
Chieti, 66100, Italy
Ente Ospedaliero Ospedali Galliera
Genova, 16132, Italy
Fondazione IRCCS Ca'Granda Ospedale Maggiore Policinico
Milan, 20122, Italy
Nuovo Ospedale Civile Sant'Agostino Estense
Modena, 41010, Italy
Policlinico Univ. Agostino Gemelli
Roma, 00168, Italy
Dip.to Med. Sperimentale -Polic.Umberto I -Univ. La Sapienza
Roma, 00185, Italy
Ospedale San Giovanni Calibita Fatebenefratelli
Roma, 00186, Italy
Policlinico Ospedale S. Andrea
Roma, 00189, Italy
Azienda Ospedaliera Citta della Salute della Scienza Torino
Torino, 10126, Italy
National Institute for Longevity Sciences NCGG
Ōbu, Aichi-ken, 474-0038, Japan
National Chiba-East-Hospital
Chuo-ku, Chiba, 260-8712, Japan
National Hospital Organization Asahikawa Medical Center
Asahikawa, Hokkaido, 070-8644, Japan
Tsukuba University Hospital
Tsukuba, Ibaraki, 305-8576, Japan
Iwate Medical University Hospital
Morioka, Iwate, 020-8505, Japan
Shonan Kamakura General Hospital
Kamakura, Kanagawa, 247-8533, Japan
Nihon Kokan Hospital
Kawasaki, Kanagawa, 210-0852, Japan
Yokohama City University Hospital
Yokohama, Kanagawa, 236-0004, Japan
Kyoto Prefectural University of Medicine
Kyoto, Kyoto, 602-8566, Japan
Rakuwakai Otowarehabilitation Hospital
Kyoto, Kyoto, 607-8113, Japan
Ina Central Hospital
Ina, Nagano, 396-8555, Japan
Matsumoto Medical Center
Matsumoto, Nagano, 399-0021, Japan
Katayama Medical Clinic
Kurashiki, Okayama-ken, 701-0192, Japan
Shiroma Clinic
Urasoe, Okinawa, 901-2102, Japan
Koshokai aino hospital
Ibaraki, Osaka, 567-0011, Japan
Sakaguchi Clinic
Sakai, Osaka, 593-8301, Japan
National Sanatorium Toneyama Hospital
Toyonaka, Osaka, 560-8552, Japan
Saitama Medical University Hospital
Iruma-Gun, Saitama, 350-0495, Japan
Nippon Medical School Hospital
Bunkyo-Ku, Tokyo, 113-8603, Japan
The University of Tokyo Hospital
Bunkyo-ku, Tokyo, 113-8655, Japan
Nozomi Memory Clinic
Mitaka-shi, Tokyo, 181-0013, Japan
Sangenjaya Nakamura Mental Clinic
Setagaya City, Tokyo, 154-0004, Japan
Kanauchi Medical Clinic
Shinjuku-ku, Tokyo, 160-0023, Japan
Tokyo Women's Medical University Hospital
Shinjuku-ku, Tokyo, 162-8666, Japan
Memory Clinic Ochanomizu
Tsukuba, Tokyo, 305 8576, Japan
National Sanatorium Hokuriku Hospital
Nanto, Toyama, 939-1893, Japan
Fukuoka University Hospital
Fukuoka, 814-0180, Japan
Kyoto University Hospital
Kyoto, 606-8507, Japan
Kyoto Minami Hospital
Kyoto, 610-0113, Japan
Utano Hospital
Kyoto, 616-8255, Japan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Osaka, 545-8586, Japan
NZOZ Wroclawskie Centrum Alzheimerowskie
Wroclaw, Lower Silesian Voivodeship, 53 139, Poland
Medycyna Milorzab
Lodz, Lódzkie, 92216, Poland
Podlaskie Centrum Psychogeriatrii
Bialystok, Podlaskie Voivodeship, 15-732, Poland
NZOZ Dom Sue Ryder - Pallmed Sp. z o.o.
Bydgoszcz, 85-796, Poland
NZOZ Wielospecjalistyczna Poradnia Lekarska
Katowice, 40-123, Poland
Specjalistyczna Praktyka Lekarska prof. Grzegorz Opala
Katowice, 40-588, Poland
Centrum Zdrowia Psychicznego
Kielce, 25411, Poland
Centrum Neurologii Klinicznej
Krakow, 31-505, Poland
NZOZ Neuromed M. I M. Nastaj sp. P.
Lublin, 20-064, Poland
Instytut Medycyny Wsi
Lublin, 20-090, Poland
NEURO-CARE Sp. z o.o. Sp. Komandytowa
Siemianowice Śląskie, 41-100, Poland
Centrum Medyczne
Warsaw, 01-697, Poland
Centralny Szpital Kliniczny MSW
Warsaw, 02-507, Poland
Santa Cruz Behavioral PSC
Bayamón, PR, 00961, Puerto Rico
Instituto de Neurologia Dra. Ivonne Fraga
San Juan, PR, 00918, Puerto Rico
Ivonne Z. Jimenez-Velazquez, MD
Carolina, 00984, Puerto Rico
Michel A. Woodbury-Farina, MD.
San Juan, 00918, Puerto Rico
SC Med Life SA
Bucharest, 010719, Romania
SC Centrul Medical Sana SRL
Bucharest, 011025, Romania
Policlinica CCBR S.R.L.
Bucharest, 30463, Romania
SC Med Life SA
Timișoara, 300166, Romania
Dong-A University Medical Center
Seogu, Busan, 49201, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Geonggi-do, 13620, South Korea
The Catholic University of Korea-Bucheon St. Mary's Hospital
Bucheon-si, Gyeonggi-do, 14647, South Korea
Hanyang University Guri Hospital
Guri-si, Gyeonggido, 11923, South Korea
Gachon University Gil Medical Center
Namdong, Incheon, 21565, South Korea
Inha University Hospital
Incheon, 22332, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Seoul St. Mary's Hospital
Seoul, 06591, South Korea
Hospital General Universitario de Elche
Elche, Alicante, 03203, Spain
Hospital General de Catalunya
Sant Cugat del Vallès, Barcelona, 08190, Spain
Hospital Virgen Del Puerto
Plasencia, Caceres, 10600, Spain
Hospital Universitario De Getafe
Madrid, Getafe, 28905, Spain
Hospital Puerta De Hierro
Majadahonda, Madrid, 28222, Spain
Centro de Atencion Especializada (CAE) OROITU
Getxo, Vizcaya, 48993, Spain
Hospital del Mar
Barcelona, 08003, Spain
Hospital Santa Creu I Sant Pau
Barcelona, 08025, Spain
Fundacion ACE-Institut Catala de Neurociences Aplicades
Barcelona, 08028, Spain
Hospital Clinic de Barcelona
Barcelona, 08036, Spain
Hospital Universitari de Bellvitge
Barcelona, 08907, Spain
Hospital Reina Sofia
Córdoba, 14004, Spain
Fundacion CITA Alzheimer
Donostia / San Sebastian, 20009, Spain
Hospital De La Princesa
Madrid, 28006, Spain
Hospital Universitario Ramon y Cajal
Madrid, 28034, Spain
Hospital Son Espases
Palma de Mallorca, 07010, Spain
Hospital Univ Sant Joan de Reus, S.A.
Reus, 43204, Spain
Hospital Doctor Peset
Valencia, 46017, Spain
Hospital Universitario La Fe de Valencia
Valencia, 46026, Spain
Plymouth Hospitals NHS Trust
Plymouth, Devon, PL6 8BX, United Kingdom
Cognitive Treatment & Research Unit
Crowborough, East Sussex, TN6 1HB, United Kingdom
Southern Health NHS
Southampton, Hampshire, SO30 3JB, United Kingdom
MAC UK Neuroscience Ltd
Blackpool, Lancs, FY20JH, United Kingdom
MAC Clinical Research
Stourton, Leeds, LS10 1DU, United Kingdom
MAC Clinical Research
Cannock, Staffordshire, WS11 0BN, United Kingdom
West London Mental Health NHS Trust
Brentford, TW8 8DS, United Kingdom
Glasgow Memory Clinic
Glasgow, G20 0XA, United Kingdom
Hammersmith Hospital
London, W12 0NN, United Kingdom
Guildford Nuffield Hospital
London, W1G 9JF, United Kingdom
Re-Cognition Health Ltd
London, W1G 9RU, United Kingdom
MAC Clinical Research
Manchester, M13 9NQ, United Kingdom
Related Publications (4)
Chandler JM, Lansdall CJ, Ye W, McDougall F, Belger M, Toth B, Mi X, Sink KM, Atkins AS. The Alzheimer's Disease Cooperative Study - Activities of Daily Living dependence score: revision and validation of an algorithm evaluating patient dependence across the spectrum of AD severity. J Prev Alzheimers Dis. 2025 Sep;12(8):100261. doi: 10.1016/j.tjpad.2025.100261. Epub 2025 Jul 1.
PMID: 40603145DERIVEDWessels AM, Lines C, Stern RA, Kost J, Voss T, Mozley LH, Furtek C, Mukai Y, Aisen PS, Cummings JL, Tariot PN, Vellas B, Dupre N, Randolph C, Michelson D, Andersen SW, Shering C, Sims JR, Egan MF. Cognitive outcomes in trials of two BACE inhibitors in Alzheimer's disease. Alzheimers Dement. 2020 Nov;16(11):1483-1492. doi: 10.1002/alz.12164. Epub 2020 Oct 13.
PMID: 33049114DERIVEDWessels 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
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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 2
- 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
September 18, 2014
First Posted
September 22, 2014
Study Start
September 30, 2014
Primary Completion
October 4, 2018
Study Completion
October 4, 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.