Study Stopped
As the feeder study (AZES) was stopped for futility after an independent assessment, this trial was also stopped.
A Study of Lanabecestat (LY3314814) in Early Alzheimer's Disease Dementia
A Randomized, Double-Blind, Delayed-Start Study of LY3314814 (AZD3293) in Early Alzheimer's Disease Dementia (Extension of Study AZES, The AMARANTH Study)
3 other identifiers
interventional
421
14 countries
133
Brief Summary
This study is an extension of study I8D-MC-AZES (NCT02245737), the AMARANTH study. The purpose of this study is to evaluate the effectiveness of the study drug lanabecestat in participants with early Alzheimer's disease dementia at the time of entry into study I8D-MC-AZES.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2017
133 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
November 21, 2016
CompletedFirst Posted
Study publicly available on registry
November 23, 2016
CompletedStudy Start
First participant enrolled
March 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 2, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 2, 2018
CompletedResults Posted
Study results publicly available
July 5, 2019
CompletedDecember 3, 2019
November 1, 2019
1.6 years
November 21, 2016
June 11, 2019
November 19, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline Analysis 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\*visit, baseline efficacy score, baseline efficacy score-by-visit interaction, disease status at baseline, apolipoprotein E4 (APOE4) status, acetylcholinesterase inhibitor (AChEI) use at baseline, age at baseline, and pooled country.
AZES Baseline through AZFD Week 26
Secondary Outcomes (5)
Change From Baseline Analysis on the Alzheimer´s Disease Cooperative Study Activities of Daily Living Inventory Instrumental Items (ADCS-iADL)
AZES Baseline through AZFD Week 26
Change From Baseline on the Functional Activities Questionnaire (FAQ) Score
AZES Baseline through AZFD Week 26
Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) Score
AZES Baseline through AZFD Week 26
Change From Baseline on the Mini-Mental Status Examination (MMSE)
AZES Baseline through AZFD Week 26
Change From Baseline Analysis on the ADAS-Cog13
AZES Baseline through AZFD Week 52
Study Arms (4)
AZES Lanabecestat 20 milligrams (mg)/AZFD Lanabecestat 20 mg
EXPERIMENTALParticipants who received Lanabecestat 20 mg in the feeder study (AZES) were randomized to receive Lanabecestat 20 mg.
AZES Lanabecestat 50 mg/AZFD Lanabecestat 50 mg
EXPERIMENTALParticipants who received Lanabecestat 50 mg in the feeder study (AZES) were randomized to receive Lanabecestat 50 mg.
AZES Placebo/AZFD Lanabecestat 20 mg
EXPERIMENTALParticipants who received placebo in the feeder study (AZES) were randomized to receive Lanabecestat 20 mg.
AZES Placebo/AZFD Lanabecestat 50 mg
EXPERIMENTALParticipants who received placebo in the feeder study (AZES) were randomized to receive Lanabecestat 50 mg.
Interventions
Administered orally
Eligibility Criteria
You may qualify if:
- Participants previously enrolled in AMARANTH (NCT02245737) who meet eligibility criteria for delayed-start I8D-MC-AZFD.
You may not qualify if:
- Participants who participate in AMARANTH (NCT02245737) who develop new conditions precluding them from enrolling into I8D-MC-AZFD.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Eli Lilly and Companycollaborator
Study Sites (133)
Banner Alzheimer's Institute
Phoenix, Arizona, 85006, United States
Territory Neurology & Research Institute
Tucson, Arizona, 85704, United States
Pacific Research Network Inc
San Diego, California, 92103, 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
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
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
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Community Clinical Research Center
Anderson, Indiana, 46011, United States
Boston Center for Memory
Newton, Massachusetts, 02459, United States
Hattiesburg Clinic
Hattiesburg, Mississippi, 39401, United States
Memory Enhancement Center of America, Inc.
Eatontown, New Jersey, 07724, 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
Integrative Clinical Trials, LLC
Brooklyn, New York, 11229, United States
Columbia University Medical Center
New York, New York, 10032, United States
University of Rochester School of Medicine
Rochester, New York, 14620, United States
Valley Medical Primary Care
Centerville, Ohio, 45459, United States
Lindner Research Center
Cincinnati, Ohio, 45219, United States
Ohio State University Medical Center
Columbus, Ohio, 43210, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, 18103, United States
Rhode Island Mood & Memory Research Institute
East Providence, Rhode Island, 02914, United States
Radiant Research
Greer, South Carolina, 29651, United States
Quillen College of Medicine, East TN State University
Johnson City, Tennessee, 37604, United States
The Memory Clinic
Bennington, Vermont, 05201, United States
Southern Neurology
Kogarah, New South Wales, 2217, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Eastern Clinical Research Unit
Box Hill, Victoria, 3128, Australia
Delmont Private Hospital
Glen Iris, Victoria, 3146, 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
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
Leuven, 3000, Belgium
AZ Delta
Roeselare, 8800, Belgium
Okanagan Clinical Trials
Kelowna, British Columbia, V1Y 1Z9, Canada
True North Clinical Research Halifax, LLC
Halifax, Nova Scotia, B3S1M7, Canada
Elizabeth Bruyere Health Centre
Ottawa, Ontario, KIN 5C8, Canada
Kawartha Regional Memory Clinic
Peterborough, Ontario, K9H2P4, Canada
Toronto Memory Program
Toronto, Ontario, M3B 2S7, Canada
Clinique de la Memoire de l'Outaouais
Gatineau, Quebec, J8T 8J1, Canada
NeuroSearch Developements
Greenfield Park, Quebec, J4V 2J2, Canada
Hopital de L'Enfant Jesus
Québec, Quebec, G1J 1Z4, Canada
Q&T Research Sherbrooke Inc
Sherbrooke, Quebec, J1J 2G2, Canada
Centre Hospitalier Universitaire La Timone
Marseille, Cedex 05, 13385, France
CHRU de Lille- Hôpital Roger Salengro
Lille, Cedex, 59037, France
CHU de Toulouse Hopital Purpan
Toulouse, Cedex, 31059, France
Hopital Neuro Pierre Wertheimer
Bron, 69677, France
CHU Bocage CMRR
Dijon, 21079, France
Hopital Broca
Paris, 75013, France
Hôpital de la Pitié-Salpêtrière
Paris, 75013, France
Hôpital Fernand Widal
Paris, 75475, France
Chu de Nantes Hopital Laennec
Saint-Herblain, 44093, France
Centre de Recherche Clinique du Gérontopôle Cité de la Santé
Toulouse, 31052, France
Hopital des Charpennes
Villeurbanne, 69100, France
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
Gemeinschaftspraxis für Neurologie und Psychiatrie
Westerstede, Lower Saxony, 26655, Germany
DataMed Klinische Studien GmbH
Cologne, North Rhine-Westphalia, 50935, Germany
Universitätsklinikum Köln
Cologne, North Rhine-Westphalia, 50937, Germany
Neurologische Praxis Siegen
Siegen, North Rhine-Westphalia, 57076, Germany
Pharm Studienzentrum Chemnitz
Mittweida, Saxony, 09648, Germany
Charité Universitätsmedizin Berlin
Berlin, 10117, Germany
Charité Universitätsmedizin Berlin
Berlin, 12203, Germany
SE Neurologiai Klinika
Budapest, 1083, Hungary
National Institute for Longevity Sciences NCGG
ÅŒbu, Aichi-ken, 474-0038, Japan
National Chiba-East-Hospital
Chuo-ku, Chiba, 260-8712, Japan
Tsukuba University Hospital
Tsukuba, Ibaraki, 305-8576, Japan
Iwate Medical University Hospital
Morioka, Iwate, 020-8505, Japan
Nihon Kokan Hospital
Kawasaki, Kanagawa, 210-0852, Japan
Katayama Medical Clinic
Kurashiki, Okayama-ken, 701-0192, Japan
Shiroma Clinic
Urasoe, Okinawa, 901-2102, Japan
Sakaguchi Clinic
Sakai, Osaka, 593-8301, Japan
National Sanatorium Toneyama Hospital
Toyonaka, Osaka, 560-8552, Japan
Memory Clinic Ochanomizu
Bunkyo-ku, Tokyo, 113-0034, Japan
Nippon Medical School Hospital
Bunkyo-Ku, Tokyo, 113-8603, Japan
The University of Tokyo Hospital
Bunkyo-ku, Tokyo, 113-8655, Japan
Tokyo Women's Medical University Hospital
Shinjuku-ku, Tokyo, 162-8666, Japan
National Sanatorium Hokuriku Hospital
Nanto, Toyama, 939-1893, Japan
Fukuoka University Hospital
Fukuoka, 814-0180, Japan
Kyoto University Hospital
Kyoto, 606-8507, Japan
Utano Hospital
Kyoto, 616-8255, Japan
Osaka City University Hospital
Osaka, 637086, Japan
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
Centrum Zdrowia Psychicznego Biomed - Jan Latala
Kielce, 25-411, Poland
Krakowska Akademia Neurologii
Krakow, 31-505, Poland
Medycyna Milorzab
Lodz, 93-118, Poland
Instytut Medycyny Wsi
Lublin, 20-950, Poland
Centrum Medyczne Neuroprotect
Warsaw, 01-697, Poland
Santa Cruz Behavioral PSC
Bayamón, 00961-6911, Puerto Rico
SC Med Life SA
Bucharest, 010719, Romania
SC Centrul Medical Sana SRL
Bucharest, 011025, Romania
Dong-A University Medical Center
Seogu, Busan, 49201, South Korea
Hanyang University Guri Hospital
Guri-si, Gyeonggido, 11923, South Korea
Inha University Hospital
Junggu, Incheon, 22332, South Korea
Samsung Medical Center
Seoul, Korea, 06351, South Korea
Gachon University Gil Medical Center
Incheon, 21565, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Seoul St. Mary's Hospital
Seoul, 06591, South Korea
Hospital General Universitario de Elche
Elche, Alicante, 03203, Spain
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Hospital Virgen Del Puerto
Plasencia, Caceres, 10600, Spain
Hospital Universitario De Getafe
Madrid, Getafe, 28905, Spain
CITA Alzheimer
Donostia / San Sebastian, Guipuzcoa, 20009, Spain
Centro de Atencion Especializada (CAE) OROITU
Getxo, Vizcaya, 48993, Spain
Fundacion ACE-Institut Catala de Neurociences Aplicades
Barcelona, 08014, Spain
Hospital Santa Creu I Sant Pau
Barcelona, 08025, Spain
Hospital Clinic I Provincial
Barcelona, 08036, 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 Universitario Dr Pesset
Valencia, 46017, Spain
Hospital Universitario La Fe de Valencia
Valencia, 46026, Spain
Re-Cognition Health Ltd
London, Greater London, W1G 9JF, United Kingdom
MAC Clinical Research-Manchester
Manchester, Greater Manchester, M13 9NQ, United Kingdom
MAC Clinical Research
Blackpool, Lancashire, FY2 0JH, United Kingdom
West London Mental Health NHS Trust
Isleworth, London, TW7 6FY, United Kingdom
MAC Clinical Research
Cannock, Staffordshire, WS11 0BN, United Kingdom
Re-Cognition Health Ltd
Guildford, Surrey, GU2 7YD, United Kingdom
Glasgow Memory Clinic
Glasgow, G20 0XA, United Kingdom
MAC Clinical Research
Leeds, LS10 1DU, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Limitations and Caveats
This study was stopped after an independent assessment concluded that the feeder study AZES was futile. Because of this, the originally planned delayed-start analysis for this study was not performed.
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
November 21, 2016
First Posted
November 23, 2016
Study Start
March 15, 2017
Primary Completion
October 2, 2018
Study Completion
October 2, 2018
Last Updated
December 3, 2019
Results First Posted
July 5, 2019
Record last verified: 2019-11
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.