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Trial record 15 of 31 for:    alzheimer dijon

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

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ClinicalTrials.gov Identifier: NCT02972658
Recruitment Status : Enrolling by invitation
First Posted : November 23, 2016
Last Update Posted : April 19, 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 : September 30, 2021
Estimated Study Completion Date : September 30, 2021


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, Senior)
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


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Locations
United States, Arizona
Banner Alzheimer's Institute
Phoenix, Arizona, United States, 85006
Territory Neurology & Research Institute
Tucson, Arizona, United States, 85704
United States, California
Senior Clinical Trials, Inc.
Laguna Hills, California, United States, 92653
Pacific Research Network Inc.
San Diego, California, United States, 92103
United States, Colorado
Mile High Research Center
Denver, Colorado, United States, 80218
United States, Connecticut
Institute For Neurodegenerative Disorders
New Haven, Connecticut, United States, 06510
United States, District of Columbia
Georgetown University Medical Center
Washington, District of Columbia, United States, 20057
United States, Florida
Brain Matters Research
Delray Beach, Florida, United States, 33445
Compass Research
Orlando, Florida, United States, 32806
IMIC, Inc.
Palmetto Bay, Florida, United States, 33157
Suncoast Neuroscience Associates
Saint Petersburg, Florida, United States, 33713
Roskamp Institute
Sarasota, Florida, United States, 34243
Infinity Clinical Reserach . LLC
Sunrise, Florida, United States, 33351
Stedman Clinical Trials
Tampa, Florida, United States, 33613
Premiere Research Institute at Palm Beach Neurology
West Palm Beach, Florida, United States, 33407
United States, Georgia
The Multiple Sclerosis Center of Atlanta
Atlanta, Georgia, United States, 30327
United States, Illinois
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Alexian Brothers Medical Center
Elk Grove Village, Illinois, United States, 60007
United States, Indiana
Community Clinical Research Center
Anderson, Indiana, United States, 46011
United States, Massachusetts
ActivMed Practices & Research, Inc
Methuen, Massachusetts, United States, 01844
Boston Center for Memory
Newton, Massachusetts, United States, 02459
United States, Mississippi
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Hattiesburg, Mississippi, United States, 39401
Hattiesburg Clinic
Hattiesburg, Mississippi, United States, 39401
United States, Missouri
Millenium Psychiatric Associates LLC
Creve Coeur, Missouri, United States, 63141
United States, New Jersey
Memory Enhancement Center of America, Inc.
Eatontown, New Jersey, United States, 07724
Mid Atlantic Geriatric Association
Manchester, New Jersey, United States, 08759
The Cognitive and Research Center of NJ
Springfield, New Jersey, United States, 07081
Advanced Memory Research Institute of New Jersey
Toms River, New Jersey, United States, 08755
United States, New York
Integrative Clinical Trials, LLC
Brooklyn, New York, United States, 11229
Columbia University Medical Center
New York, New York, United States, 10032
University of Rochester School of Medicine
Rochester, New York, United States, 14620
United States, Ohio
Valley Medical Primary Care
Centerville, Ohio, United States, 45459
Lindner Research Center
Cincinnati, Ohio, United States, 45219
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Lehigh Valley Hospital
Allentown, Pennsylvania, United States, 18103
United States, Rhode Island
Rhode Island Mood & Memory Research Institute
East Providence, Rhode Island, United States, 02914
United States, South Carolina
Radiant Research
Greer, South Carolina, United States, 29650
Radiant Research
Greer, South Carolina, United States, 29651
United States, Tennessee
Quillen College of Medicine, East TN State University
Johnson City, Tennessee, United States, 37604
United States, Vermont
The Memory Clinic
Bennington, Vermont, United States, 05201
Australia
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Adelaide, Australia, 5000
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Box Hill, Australia, 3128
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Camberwell, Australia, 3124
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Glen Iris, Australia, 3146
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Kogarah, Australia, 2217
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Nedlands, Australia, 6009
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Noble Park, Australia, 3174
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Parkville, Australia, 3052
Belgium
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Brussels, Belgium, 1020
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Brussels, Belgium, 1200
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Edegem, Belgium, 2650
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Hasselt, Belgium, 3500
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Leuven, Belgium, 3000
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Roeselare, Belgium, 8800
Canada
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Canada Customer Response Center
Quebec, Canada, J8T 8J1
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Sherbrooke, Canada, J1J 2G2
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Sherbrooke, Canada, J1J3H5
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Toronto, Canada, M3B 2S7
France
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Bron Cedex, France, 69677
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Bron, France, 69677
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Ceaux, France, 44093
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Dijon, France, 21079
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Lille, France, 59037
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Marseille, France, 13385
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Paris, France, 75013
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Paris, France, 75475
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Toulouse, France, 31052
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Toulouse, France, 31059
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Villeurbanne, France, 69100
Germany
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Bayern, Germany, 80331
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Bayern, Germany, 83209
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Berlin, Germany, 10117
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Berlin, Germany, 12203
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Bochum, Germany, 44791
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Bonn, Germany, 53105
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Halle, Germany, 06097
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Homburg, Germany, 66421
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Koln, Germany, 50935
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Koln, Germany, 50937
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Magdeburg, Germany, 39120
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Mittweida, Germany, 09648
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Munchen, Germany, 81675
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Nürnberg, Germany, 90402
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Siegen, Germany, 57076
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Tubingen, Germany, 72076
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Ulm, Germany, 89081
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Wenzenbach, Germany, 93173
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Westerstede, Germany, 26655
Hungary
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Budapest, Hungary, 1083
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Budapest, Hungary, 1097
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Debrecen, Hungary, 4012
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Debrecen, Hungary, 4031
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Pecs, Hungary, 7623
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Szeged, Hungary, 6720
Italy
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Ancona, Italy, 60126
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Baggiovara, Italy, 41100
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Biella, Italy, 13900
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Brescia, Italy, 25125
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Cefalù, Italy, 90015
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Chieti, Italy, 66100
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Genova, Italy, 16128
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Milano, Italy, 20122
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Milano, Italy, 20900
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Pisa, Italy, 56126
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Roma, Italy, 00161
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Roma, Italy, 00168
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Roma, Italy, 00189
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Rome, Italy, 00153
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Torino, Italy, 10126
Japan
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Asahikawa, Japan, 070-8644
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Bunkyo-Ku, Japan, 113-8603
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Bunkyō-Ku, Japan, 113-0034
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Chuo-ku, Japan, 260-8712
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Fukuoka, Japan, 814-0180
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Ibaragi, Japan, 567-0011
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Ina, Japan, 396-8555
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Iruma-Gun, Japan, 350-0495
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Kamakura, Japan, 247-8533
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Kawasaki, Japan, 210-0852
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Kurashiki, Japan, 701-0192
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Kyoto, Japan, 602-8566
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Kyoto, Japan, 606-8507
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Kyoto, Japan, 607-8062
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Kyoto, Japan, 616-8255
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Kyoto, Japan
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Matsumoto, Japan, 399-0021
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Mitaka-shi, Japan, 181-0013
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Morioka, Japan, 020-8505
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Nanto, Japan, 939-1893
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Obu, Japan, 474-0038
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Osaka, Japan, 545-8586
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Sakai, Japan, 593-8301
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Setagaya, Japan, 154-0004
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Shinjuku-ku, Japan, 160-0023
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Shinjuku-ku, Japan, 162-8666
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Tokyo, Japan, 113-8655
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Toyonaka, Japan, 560-8552
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Tsukuba, Japan, 305-8576
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Urasoe, Japan, 901-2102
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Yokohama, Japan, 236-0004
Korea, Republic of
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Bucheon, Korea, Republic of, 14647
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Busan, Korea, Republic of, 49201
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Gyeonggi-do, Korea, Republic of, 11923
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Gyeonggi-do, Korea, Republic of, 13620
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Incheon, Korea, Republic of, 21565
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Incheon, Korea, Republic of, 22332
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Seongnam-si, Korea, Republic of, 13620
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Seoul, Korea, Republic of, 05505
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Seoul, Korea, Republic of, 06351
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Seoul, Korea, Republic of, 06351
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Seoul, Korea, Republic of, 06591
Poland
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Białystok, Poland, 15-732
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Bydgoszcz, Poland, 85-796
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Katowice, Poland, 40-123
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Katowice, Poland, 40-588
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Katowice, Poland, 40749
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Kielce, Poland, 25-411
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Krakow, Poland, 31-505
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Lublin, Poland, 20-950
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Warszawa, Poland, 01-697
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Warszawa, Poland, 02-507
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Wrocław, Poland, 53-203
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Łódź, Poland, 93-118
Puerto Rico
Santa Cruz Behavioral PSC
Bayamón, Puerto Rico, 00961-6911
Romania
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Bucuresti, Romania, 010719
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Bucuresti, Romania, 011025
Spain
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Alicante, Spain, 03203
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Barcelona, Spain, 08003
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Barcelona, Spain, 08014
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Barcelona, Spain, 08025
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Barcelona, Spain, 08036
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Barcelona, Spain, 08760
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Barcelona, Spain, 08907
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Caceres, Spain, 10600
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Cordoba, Spain, 14011
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Getafe, Spain, 28905
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Getxo, Spain, 48993
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Goiauzoa, Spain, 20009
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Madrid, Spain, 28006
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Madrid, Spain, 28034
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Madrid, Spain, 28222
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Palma de Mallorca, Spain, 07010
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Tarragona, Spain, 43204
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Valencia, Spain, 46017
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Valencia, Spain, 46026
United Kingdom
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Blackpool, United Kingdom, FY2 0JH
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Cannock, United Kingdom, WS11 0BN
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Crowborough, United Kingdom, TN6 1HB
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Glasgow, United Kingdom, G20 0XA
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Isleworth, United Kingdom, TW7 6FY
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Leeds, United Kingdom, LS10 1DU
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London, United Kingdom, W12 0NN
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London, United Kingdom, W1G 9JF
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London, United Kingdom, W1G 9RU
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Manchester, United Kingdom, M13 9NQ
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Plymouth, United Kingdom, PL6 8BT
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Southampton, United Kingdom, SO30 3JB
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Surrey, United Kingdom, GU2 7YD
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: April 19, 2018
Last Verified: April 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