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A Study of Lanabecestat (LY3314814) in Early Alzheimer's Disease Dementia

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ClinicalTrials.gov Identifier: NCT02972658
Recruitment Status : Recruiting
First Posted : November 23, 2016
Last Update Posted : September 21, 2018
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Eli Lilly and Company

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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: Lanabecestat Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Delayed-Start Study of LY3314814 (AZD3293) in Early Alzheimer's Disease Dementia (Extension of Study AZES, The AMARANTH Study)
Actual Study Start Date : March 15, 2017
Estimated Primary Completion Date : October 1, 2018
Estimated Study Completion Date : October 1, 2018


Arm Intervention/treatment
Experimental: Lanabecestat Dose 1
Lanabecestat given orally.
Drug: Lanabecestat
Administered orally
Other Names:
  • LY3314814
  • AZD3293

Experimental: Lanabecestat Dose 2
Lanabecestat given orally.
Drug: Lanabecestat
Administered orally
Other Names:
  • LY3314814
  • AZD3293

Experimental: AZES Placebo Arm / AZFD Dose 1
Lanabecestat given orally.
Drug: Lanabecestat
Administered orally
Other Names:
  • LY3314814
  • AZD3293

Experimental: AZES Placebo Arm / AZFD Dose 2
Lanabecestat given orally.
Drug: Lanabecestat
Administered orally
Other Names:
  • LY3314814
  • AZD3293




Primary Outcome Measures :
  1. Delayed Start Analysis on the 13-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) [ Time Frame: AZES Baseline through AZFD Week 26 ]
    Delayed start analysis on the ADAS-Cog13


Secondary Outcome Measures :
  1. Delayed Start Analysis on the Alzheimer´s Disease Cooperative Study Activities of Daily Living Inventory (ADCS-iADL) Instrumental Items [ Time Frame: AZES Baseline through AZFD Week 26 ]
    Delayed start analysis on the ADCS-iADL instrumental items

  2. Delayed Start Analysis on the Functional Activities Questionnaire (FAQ) Score [ Time Frame: AZES Baseline through AZFD Week 26 ]
    Delayed start analysis on the FAQ score

  3. Delayed Start Analysis on the Integrated Alzheimer's Disease Rating Scale (iADRS) Score [ Time Frame: AZES Baseline through AZFD Week 26 ]
    Delayed start analysis on the iADRS score

  4. Delayed Start Analysis on the Mini-Mental Status Examination (MMSE) [ Time Frame: AZES Baseline through AZFD Week 26 ]
    Delayed start analysis on the MMSE

  5. Delayed Start Analysis on the ADAS-Cog13 [ Time Frame: AZES Baseline through AZFD Week 52 ]
    Delayed start analysis on the ADAS-Cog13



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants previously enrolled in AMARANTH (NCT02245737) who meet eligibility criteria for delayed start I8D-MC-AZFD.

Exclusion Criteria:

  • Participants who participate in AMARANTH (NCT02245737) who develop new conditions precluding them from enrolling into I8D-MC-AZFD.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02972658


Contacts
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559

  Hide Study Locations
Locations
United States, Arizona
Banner Alzheimer's Institute Active, not recruiting
Phoenix, Arizona, United States, 85006
Territory Neurology & Research Institute Active, not recruiting
Tucson, Arizona, United States, 85704
United States, California
Pacific Research Network Inc Active, not recruiting
San Diego, California, United States, 92103
United States, Colorado
Mile High Research Center Active, not recruiting
Denver, Colorado, United States, 80218
United States, Connecticut
Institute for Neurodegenerative Disorders Active, not recruiting
New Haven, Connecticut, United States, 06510
United States, District of Columbia
Georgetown University Medical Center Active, not recruiting
Washington, District of Columbia, United States, 20057
United States, Florida
Brain Matters Research Active, not recruiting
Delray Beach, Florida, United States, 33445
Compass Research Active, not recruiting
Orlando, Florida, United States, 32806
IMIC, Inc. Active, not recruiting
Palmetto Bay, Florida, United States, 33157
Suncoast Neuroscience Associates Active, not recruiting
Saint Petersburg, Florida, United States, 33713
Roskamp Institute Active, not recruiting
Sarasota, Florida, United States, 34243
Premiere Research Institute at Palm Beach Neurology Active, not recruiting
West Palm Beach, Florida, United States, 33407
United States, Georgia
The Multiple Sclerosis Center of Atlanta Active, not recruiting
Atlanta, Georgia, United States, 30327
United States, Illinois
University of Chicago Medical Center Active, not recruiting
Chicago, Illinois, United States, 60637
United States, Indiana
Community Clinical Research Center Recruiting
Anderson, Indiana, United States, 46011
Contact    765-298-2040      
Principal Investigator: Larry L Blankenship         
United States, Massachusetts
Boston Center for Memory Active, not recruiting
Newton, Massachusetts, United States, 02459
United States, Mississippi
Hattiesburg Clinic Active, not recruiting
Hattiesburg, Mississippi, United States, 39401
United States, New Jersey
Memory Enhancement Center of America, Inc. Active, not recruiting
Eatontown, New Jersey, United States, 07724
The Cognitive and Research Center of NJ Active, not recruiting
Springfield, New Jersey, United States, 07081
Advanced Memory Research Institute of New Jersey Active, not recruiting
Toms River, New Jersey, United States, 08755
United States, New York
Integrative Clinical Trials, LLC Active, not recruiting
Brooklyn, New York, United States, 11229
Columbia University Medical Center Active, not recruiting
New York, New York, United States, 10032
University of Rochester School of Medicine Active, not recruiting
Rochester, New York, United States, 14620
United States, Ohio
Valley Medical Primary Care Active, not recruiting
Centerville, Ohio, United States, 45459
Lindner Research Center Active, not recruiting
Cincinnati, Ohio, United States, 45219
Ohio State University Medical Center Active, not recruiting
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Lehigh Valley Hospital Active, not recruiting
Allentown, Pennsylvania, United States, 18103
United States, Rhode Island
Rhode Island Mood & Memory Research Institute Active, not recruiting
East Providence, Rhode Island, United States, 02914
United States, South Carolina
Radiant Research Active, not recruiting
Greer, South Carolina, United States, 29651
United States, Tennessee
Quillen College of Medicine, East TN State University Active, not recruiting
Johnson City, Tennessee, United States, 37604
United States, Vermont
The Memory Clinic Active, not recruiting
Bennington, Vermont, United States, 05201
Australia, New South Wales
Southern Neurology Active, not recruiting
Kogarah, New South Wales, Australia, 2217
Australia, South Australia
Royal Adelaide Hospital Active, not recruiting
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Eastern Clinical Research Unit Active, not recruiting
Box Hill, Victoria, Australia, 3128
Delmont Private Hospital Active, not recruiting
Glen Iris, Victoria, Australia, 3146
The Florey Institute of Neuroscience and Mental Health Active, not recruiting
Parkville, Victoria, Australia, 3052
Australia, Western Australia
Australian Alzheimer's Research Foundation Active, not recruiting
Nedlands, Western Australia, Australia, 6009
Australia
Neuro Trials Victoria Pty Ltd Active, not recruiting
Noble Park, Australia, 3174
Belgium
Jessa Ziekenhuis Active, not recruiting
Hasselt, Limburg, Belgium, 3500
Hopital Universitaire Brugmann Brussel Active, not recruiting
Brussels, Belgium, 1020
Cliniques Universitaires Saint-Luc Active, not recruiting
Brussels, Belgium, 1200
Hospital Universitaire Erasme Brussel Active, not recruiting
Brussel, Belgium, 1070
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg Active, not recruiting
Leuven, Belgium, 3000
AZ Delta Active, not recruiting
Roeselare, Belgium, 8800
Canada, British Columbia
Okanagan Clinical Trials Active, not recruiting
Kelowna, British Columbia, Canada, V1Y 1Z9
Canada, Nova Scotia
True North Clinical Research Halifax, LLC Active, not recruiting
Halifax, Nova Scotia, Canada, B3S1M7
Canada, Ontario
Elizabeth Bruyere Health Centre Active, not recruiting
Ottawa, Ontario, Canada, KIN 5C8
Kawartha Regional Memory Clinic Active, not recruiting
Peterborough, Ontario, Canada, K9H2P4
Toronto Memory Program Active, not recruiting
Toronto, Ontario, Canada, M3B 2S7
Canada, Quebec
Clinique de la Memoire de l'Outaouais Active, not recruiting
Gatineau, Quebec, Canada, J8T 8J1
NeuroSearch Developements Active, not recruiting
Greenfield Park, Quebec, Canada, J4V 2J2
Hopital de L'Enfant Jesus Active, not recruiting
Quebec City, Quebec, Canada, G1J 1Z4
Q&T Research Sherbrooke Inc Active, not recruiting
Sherbrooke, Quebec, Canada, J1J 2G2
France
Centre Hospitalier Universitaire La Timone Active, not recruiting
Marseille, Cedex 05, France, 13385
CHRU de Lille- Hôpital Roger Salengro Active, not recruiting
Lille, Cedex, France, 59037
CHU de Toulouse Hopital Purpan Active, not recruiting
Toulouse, Cedex, France, 31059
Hopital Neuro Pierre Wertheimer Active, not recruiting
Bron Cedex, France, 69677
Chu de Nantes Hopital Laennec Active, not recruiting
Cedex 1, France, 44093
CHU Bocage CMRR Active, not recruiting
Dijon, France, 21079
Hopital Broca Active, not recruiting
Paris, France, 75013
Hôpital de la Pitié-Salpêtrière Active, not recruiting
Paris, France, 75013
Hôpital Fernand Widal Active, not recruiting
Paris, France, 75475
Centre de Recherche Clinique du Gérontopôle Cité de la Santé Active, not recruiting
Toulouse, France, 31052
Hopital des Charpennes Recruiting
Villeurbanne, France, 69100
Contact    330472432050      
Principal Investigator: Pierre Krolak-Salmon         
Germany
Universitätsklinikum Ulm Active, not recruiting
Ulm, Baden-Württemberg, Germany, 89081
Studien und Gedächtniszentrum München Active, not recruiting
München, Bayern, Germany, 80331
Klinikum Rechts der Isar der TU München Active, not recruiting
München, Bayern, Germany, 81675
Gemeinschaftspraxis für Neurologie und Psychiatrie Active, not recruiting
Westerstede, Niedersachsen, Germany, 26655
DataMed Klinische Studien GmbH Active, not recruiting
Köln, Nordrhein-Westfalen, Germany, 50935
Universitätsklinikum Köln Active, not recruiting
Köln, Nordrhein-Westfalen, Germany, 50937
Neurologische Praxis Siegen Active, not recruiting
Siegen, Nordrhein-Westfalen, Germany, 57076
Pharm Studienzentrum Chemnitz Active, not recruiting
Mittweida, Sachsen, Germany, 09648
Charité Universitätsmedizin Berlin Active, not recruiting
Berlin, Germany, 10117
Charité Universitätsmedizin Berlin Active, not recruiting
Berlin, Germany, 12203
Hungary
SE Neurologiai Klinika Active, not recruiting
Budapest, Hungary, 1083
Japan
National Institute for Longevity Sciences NCGG Active, not recruiting
Obu, Aichi, Japan, 474-0038
National Chiba-East-Hospital Active, not recruiting
Chuo-ku, Chiba, Japan, 260-8712
Tsukuba University Hospital Active, not recruiting
Tsukuba, Ibaraki, Japan, 305-8576
Iwate Medical University Hospital Active, not recruiting
Morioka, Iwate, Japan, 020-8505
Nihon Kokan Hospital Active, not recruiting
Kawasaki, Kanagawa, Japan, 210-0852
Katayama Medical Clinic Active, not recruiting
Kurashiki, Okayama, Japan, 701-0192
Shiroma Clinic Active, not recruiting
Urasoe, Okinawa, Japan, 901-2102
Sakaguchi Clinic Active, not recruiting
Sakai, Osaka, Japan, 593-8301
National Sanatorium Toneyama Hospital Active, not recruiting
Toyonaka, Osaka, Japan, 560-8552
Memory Clinic Ochanomizu Active, not recruiting
Bunkyo-ku, Tokyo, Japan, 113-0034
Nippon Medical School Hospital Active, not recruiting
Bunkyo-Ku, Tokyo, Japan, 113-8603
The University of Tokyo Hospital Active, not recruiting
Bunkyo-ku, Tokyo, Japan, 113-8655
Tokyo Women's Medical University Hospital Active, not recruiting
Shinjuku-ku, Tokyo, Japan, 162-8666
National Sanatorium Hokuriku Hospital Active, not recruiting
Nanto, Toyama, Japan, 939-1893
Fukuoka University Hospital Active, not recruiting
Fukuoka, Japan, 814-0180
Kyoto University Hospital Active, not recruiting
Kyoto, Japan, 606-8507
Utano Hospital Active, not recruiting
Kyoto, Japan, 616-8255
Osaka City University Hospital Active, not recruiting
Osaka, Japan, 637086
Korea, Republic of
Dong-A University Medical Center Active, not recruiting
Seo-gu, Busan, Korea, Republic of, 49201
Hanyang University Guri Hospital Active, not recruiting
Guri-si, Gyeonggido, Korea, Republic of, 11923
Inha University Hospital Completed
Jung-gu, Incheon, Korea, Republic of, 22332
Samsung Medical Center Completed
Seoul, Korea, Korea, Republic of, 06351
Asan Medical Center Completed
Songpa-gu, Seoul, Korea, Republic of, 05505
Gachon University Gil Medical Center Active, not recruiting
Incheon, Korea, Republic of, 21565
Seoul St. Mary's Hospital Completed
Seoul, Korea, Republic of, 06591
Poland
Podlaskie Centrum Psychogeriatrii Active, not recruiting
Białystok, Podlaskie, Poland, 15-732
NZOZ Dom Sue Ryder - Pallmed Sp. z o.o. Active, not recruiting
Bydgoszcz, Poland, 85-796
NZOZ Wielospecjalistyczna Poradnia Lekarska Active, not recruiting
Katowice, Poland, 40-123
Centrum Zdrowia Psychicznego Biomed - Jan Latala Active, not recruiting
Kielce, Poland, 25-411
Krakowska Akademia Neurologii Active, not recruiting
Krakow, Poland, 31-505
Medycyna Milorzab Active, not recruiting
Lodz, Poland, 93-118
Instytut Medycyny Wsi Active, not recruiting
Lublin, Poland, 20-950
Centrum Medyczne Neuroprotect Active, not recruiting
Warszawa, Poland, 01-697
Puerto Rico
Santa Cruz Behavioral PSC Active, not recruiting
Bayamón, Puerto Rico, 00961-6911
Romania
SC Med Life SA Active, not recruiting
Bucuresti, Romania, 010719
SC Centrul Medical Sana SRL Active, not recruiting
Bucuresti, Romania, 011025
Spain
Hospital General Universitario de Elche Active, not recruiting
Elche, Alicante, Spain, 03203
Hospital Universitari de Bellvitge Active, not recruiting
Hospitalet de Llobregat, Barcelona, Spain, 08907
Hospital Virgen Del Puerto Active, not recruiting
Plasencia, Caceres, Spain, 10600
Hospital Universitario De Getafe Active, not recruiting
Madrid, Getafe, Spain, 28905
CITA Alzheimer Active, not recruiting
San Sebastian, Guipuzcoa, Spain, 20009
Hospital Son Espases Active, not recruiting
Son Espases, Palma De Mallorca, Spain, 07010
Centro de Atencion Especializada (CAE) OROITU Active, not recruiting
Getxo, Vizcaya, Spain, 48993
Fundacion ACE-Institut Catala de Neurociences Aplicades Active, not recruiting
Barcelona, Spain, 08014
Hospital Santa Creu I Sant Pau Active, not recruiting
Barcelona, Spain, 08025
Hospital Clinic I Provincial Active, not recruiting
Barcelona, Spain, 08036
Hospital De La Princesa Active, not recruiting
Madrid, Spain, 28006
Hospital Universitario Ramon y Cajal Active, not recruiting
Madrid, Spain, 28034
Hospital Universitario Dr Pesset Active, not recruiting
Valencia, Spain, 46017
Hospital Universitario La Fe de Valencia Active, not recruiting
Valencia, Spain, 46026
United Kingdom
Glasgow Memory Clinic Active, not recruiting
Scotland, Glasgow, United Kingdom, G20 0XA
Re-Cognition Health Ltd Active, not recruiting
London, Greater London, United Kingdom, W1G 9JF
MAC Clinical Research-Manchester Active, not recruiting
Manchester, Greater Manchester, United Kingdom, M13 9NQ
MAC Clinical Research Active, not recruiting
Blackpool, Lancashire, United Kingdom, FY2 0JH
West London Mental Health NHS Trust Active, not recruiting
Isleworth, London, United Kingdom, TW7 6FY
MAC Clinical Research Active, not recruiting
Cannock, Staffordshire, United Kingdom, WS11 0BN
Re-Cognition Health Ltd Active, not recruiting
Guildford, Surrey, United Kingdom, GU2 7YD
MAC Clinical Research Active, not recruiting
Leeds, United Kingdom, LS10 1DU
Sponsors and Collaborators
Eli Lilly and Company
AstraZeneca
Investigators
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

Additional Information:
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02972658     History of Changes
Other Study ID Numbers: 16557
I8D-MC-AZFD ( Other Identifier: Eli Lilly and Company )
2016-003440-36 ( EudraCT Number )
First Posted: November 23, 2016    Key Record Dates
Last Update Posted: September 21, 2018
Last Verified: September 17, 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com.

This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.


Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Eli Lilly and Company:
Alzheimer's Disease
Dementia
Brain Diseases
Neurodegenerative Diseases
Central Nervous System Diseases
Nervous System Diseases
Mental Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Tauopathies
Memory
Amyloid

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders