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An Efficacy and Safety Study of Lanabecestat (LY3314814) in Early Alzheimer's Disease (AMARANTH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02245737
Recruitment Status : Terminated (An independent assessment concluded the trial was not likely to meet the primary endpoint upon completion and therefore, trial stopped for futility)
First Posted : September 22, 2014
Last Update Posted : October 26, 2018
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Eli Lilly and Company

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.

Condition or disease Intervention/treatment Phase
Alzheimer´s Disease Drug: Lanabecestat Drug: Placebo Phase 2 Phase 3

Detailed Description:
Participants who meet other study entry requirements will be required to undergo either an amyloid positron emission tomography (PET) scan or a lumbar puncture for cerebrospinal fluid (CSF) sampling at screening to document presence of abnormal levels of brain and CSF amyloid for study inclusion. The study includes 2 sub-studies: the participants that undergo a PET scan at screening will be included in the PET-substudy, and participants who undergo a lumbar puncture at screening will be included in the CSF substudy until each of these substudies are completed.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7255 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : September 30, 2014
Actual Primary Completion Date : October 4, 2018
Actual Study Completion Date : October 4, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Lanabecestat 20 mg
Lanabecestat 20 milligrams (mg) given orally once daily for 104 weeks.
Drug: Lanabecestat
Administered orally
Other Names:
  • LY3314814
  • AZD3293

Experimental: Lanabecestat 50 mg
Lanabecestat 50 mg given orally once daily for 104 weeks.
Drug: Lanabecestat
Administered orally
Other Names:
  • LY3314814
  • AZD3293

Placebo Comparator: Placebo
Placebo given orally once daily for 104 weeks.
Drug: Placebo
Administered orally




Primary Outcome Measures :
  1. Change from Baseline on the 13-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) [ Time Frame: Baseline, Week 104 ]

Secondary Outcome Measures :
  1. Change from Baseline on the Alzheimer´s Disease Cooperative Study Activities of Daily Living Inventory (ADCS-iADL) Instrumental Items [ Time Frame: Baseline, Week 104 ]
  2. Change from Baseline on the Functional Activities Questionnaire (FAQ) Score [ Time Frame: Baseline, Week 104 ]
  3. Change from Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) Score [ Time Frame: Baseline, Week 104 ]
  4. Change from Baseline on the Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score [ Time Frame: Baseline, Week 104 ]
  5. Time in Clinical Dementia Rating (CDR) Global Score Stage [ Time Frame: Baseline through Loss of 1 Global Stage or Week 104 ]
  6. Change from Baseline in Neuropsychiatric Inventory (NPI) Score [ Time Frame: Baseline, Week 104 ]
  7. Change from Baseline on the Mini-Mental Status Examination (MMSE) [ Time Frame: Baseline, Week 104 ]
  8. Pharmacodynamics (PD): Change from Baseline in Concentration of Cerebrospinal Fluid (CSF) Biomarker Aβ1-42 [ Time Frame: Baseline, Week 97 ]
  9. PD: Change from Baseline in Concentration of CSF Biomarker Aβ1-40 [ Time Frame: Baseline, Week 97 ]
  10. Change from Baseline in CSF Total Tau [ Time Frame: Baseline, Week 104 ]
  11. Change from Baseline in CSF Phosphorylated Tau [ Time Frame: Baseline, Week 104 ]
  12. Change From Baseline in Amyloid Imaging Positron Emission Tomography (AV-45 PET) [ Time Frame: Baseline, Week 104 ]
  13. Change From Baseline in Tau PET [ Time Frame: Baseline, Week 104 ]
  14. Change From Baseline in PET Using Fluorine-18 Fluorodeoxyglucose (18F-FDG) [ Time Frame: Baseline, Week 104 ]
  15. Change from Baseline in Whole Brain Volume [ Time Frame: Baseline, Week 104 ]
  16. Population Pharmacokinetics (PK): Apparent Oral Clearance of Lanabecestat [ Time Frame: Week 4 through Week 91 ]
  17. Population PK: Central Volume of Distribution of Lanabecestat [ Time Frame: Week 4 through Week 91 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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): NCT02245737


  Hide Study Locations
Locations
United States, Arizona
Banner Alzheimer's Institute
Phoenix, Arizona, United States, 85006
St Josephs Hospital and Medical Center
Phoenix, Arizona, United States, 85013
Banner Sun Health Research Institute
Sun City, Arizona, United States, 85351
Territory Neurology & Research Institute
Tucson, Arizona, United States, 85704
United States, California
Positron Research International
Fremont, California, United States, 94538
Alliance Research Centers
Laguna Hills, California, United States, 92653
Senior Clinical Trials, Inc.
Laguna Hills, California, United States, 92653
Collaborative Neuroscience Network - CNS
Long Beach, California, United States, 90806
Pacific Research Network Inc
San Diego, California, United States, 92103
San Francisco Clinical Research Center
San Francisco, California, United States, 94109
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
Direct Helpers Medical Center
Hialeah, Florida, United States, 33012
Berma Research
Hialeah, Florida, United States, 33016
Galiz Research
Hialeah, Florida, United States, 33016
MaxBlue Institute
Hialeah, Florida, United States, 33018
Alzheimer's Research and Treatment Center
Lake Worth, Florida, United States, 33449
Miami Jewish Health Systems
Miami, Florida, United States, 33137
Medical Research Center
Miami, Florida, United States, 33144
Allied Biomedical Research Institute, Inc.
Miami, Florida, United States, 33155
Advance Medical Research Institute
Miami, Florida, United States, 33174
New Horizon Research Center
Miami, Florida, United States, 33175
JDH Medical Group, LLC
Miami, Florida, United States, 33186
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 Research, LLC
Sunrise, Florida, United States, 33351
Stedman Clinical Trials
Tampa, Florida, United States, 33613
Olympian Clinical Research
Tampa, Florida, United States, 33614
Compass Research
The Villages, Florida, United States, 32162
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
Atlanta Center of Medical Research
Atlanta, Georgia, United States, 30331
Carman Research
Smyrna, Georgia, United States, 30080
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
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202
United States, Massachusetts
ActivMed Practices & Research, Inc
Methuen, Massachusetts, United States, 01844
Boston Center for Memory
Newton, Massachusetts, United States, 02459
Springfield Neurology Associates
Springfield, Massachusetts, United States, 01104
United States, Mississippi
Hattiesburg Clinic
Hattiesburg, Mississippi, United States, 39401
United States, Missouri
Millennium Psychiatric Associates, LLV
Saint Louis, Missouri, United States, 63141
St. Louis Clinical Trials, LC
Saint Louis, Missouri, United States, 63141
United States, New Jersey
Memory Enhancement Center of America, Inc.
Eatontown, New Jersey, United States, 07724
AdvanceMed Research
Lawrenceville, New Jersey, United States, 08648
Alzheimer's Research Company
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
Bio Behavioral Health
Toms River, New Jersey, United States, 08755
Neurology Specialists of Monmouth County
West Long Branch, New Jersey, United States, 07764
United States, New York
Integrative Clinical Trials, LLC
Brooklyn, New York, United States, 11229
SPRI Clinical Trials, LLC.
Brooklyn, New York, United States, 11235
Alzheimer's Disease and Memory Disorders Center
Buffalo, New York, United States, 14203
Empire Neurology, PC
Latham, New York, United States, 12110
Clinilabs, Inc (New York)
New York, New York, United States, 10019
Columbia University Medical Center
New York, New York, United States, 10032
University of Rochester
Rochester, New York, United States, 14620
United States, North Carolina
Alzheimer's Memory Center
Charlotte, North Carolina, United States, 28270
United States, Ohio
Valley Medical Primary Care
Centerville, Ohio, United States, 45459
Christ Hospital
Cincinnati, Ohio, United States, 45219
Ohio State University Medical Center
Columbus, Ohio, United States, 43221
United States, Oregon
The Corvallis Clinic P.C.
Corvallis, Oregon, United States, 97330
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
Roper St. Francis Healthcare
Charleston, South Carolina, United States, 29401
Radiant Research
Greer, South Carolina, United States, 29651
United States, Tennessee
Quillen College of Medicine, East TN State University
Johnson City, Tennessee, United States, 37605
United States, Texas
Senior Adults Specialty Research Inc
Austin, Texas, United States, 78757
Texas Health Physicians Group
Dallas, Texas, United States, 75231
Medical Group of Texas
Fort Worth, Texas, United States, 76104
University of Texas Health Services Center - Houston
Houston, Texas, United States, 77054
United States, Utah
University of Utah School of Medicine
Salt Lake City, Utah, United States, 84108
United States, Vermont
The Memory Clinic
Bennington, Vermont, United States, 05201
Australia, New South Wales
Southern Neurology
Kogarah, New South Wales, Australia, 2217
Australia, Queensland
Griffith University
Goldcoast, Queensland, Australia, 4222
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Box Hill Hospital
Box Hill, Victoria, Australia, 3128
Delmont Private Hospital
Glen Iris, Victoria, Australia, 3146
Heidelberg Repatriation Hospital
Heidelberg, Victoria, Australia, 3081
The Florey Institute of Neuroscience and Mental Health
Parkville, Victoria, Australia, 3052
Australia, Western Australia
Australian Alzheimer's Research Foundation
Nedlands, Western Australia, Australia, 6009
Australia
Neuro Trials Victoria Pty Ltd
Noble Park, Australia, 3174
Belgium
Jessa Ziekenhuis
Hasselt, Limburg, Belgium, 3500
Hopital Universitaire Brugmann Brussel
Brussels, Belgium, 1020
Cliniques Universitaires Saint-Luc
Brussels, Belgium, 1200
Hospital Universitaire Erasme Brussel
Brussel, Belgium, 1070
Universitair Ziekenhuis Antwerpen
Edegem, Belgium, 2650
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
Leuven, Belgium, 3000
Heilig Hartziekenhuis
Roeselare, Belgium, 8800
Canada, British Columbia
The Medical Arts Health Research Group
Kamloops, British Columbia, Canada, V2C 1K7
Okanagan Clinical Trials
Kelowna, British Columbia, Canada, V1Y 1Z9
University of British Columbia
Vancouver, British Columbia, Canada, V6T 2B5
Royal Jubilee Hospital
Victoria, British Columbia, Canada, V8R 158
Canada, Nova Scotia
True North Clinical Research Halifax, LLC
Halifax, Nova Scotia, Canada, B3S1M7
Canada, Ontario
Bruyere Continuing Care
Ottawa, Ontario, Canada, K1N 5C8
Kawartha Regional Memory Clinic
Peterborough, Ontario, Canada, K9H2P4
Toronto Memory Program
Toronto, Ontario, Canada, M3B2S7
Toronto Western Hospital
Toronto, Ontario, Canada, M5T2S8
Canada, Qubec
CSSS-Institut Universitaire Gériatric de Sherbrooke
Sherbrooke, Qubec, Canada, J1J3H5
Canada, Quebec
Clinique de la Memoire de l'Outaouais
Gatineau, Quebec, Canada, J8T 8J1
NeuroSearch Developements
Greenfield Park, Quebec, Canada, J4V 2J2
Hopital Maisonneure-Rosemount
Montreal, Quebec, Canada, H1T 2M4
Hopital de L'Enfant Jesus
Quebec City, Quebec, Canada, G1J 1Z4
Q&T Research Sherbrooke Inc
Sherbrooke, Quebec, Canada, J1J 2G2
France
CHU de Toulouse Hopital Purpan
Toulouse, Cedex 9, France, 31059
Hopital Neuro Pierre Wertheimer
Bron Cedex, France, 69677
Chu de Nantes Hopital Laennec
Cedex 1, France, 44093
CHU Dijonon
Dijon Cedex, France, 21033
CHRU Lille - Hopital Roger Salengro
Lille Cedex, France, 59037
CHU Hopital de la Timone
Marseille Cedex 05, France, 13385
Hopital Broca
Paris, France, 75013
Hopital de la Pitie Salpetriere
Paris, France, 75013
Hopital Lariboisière
Paris, France, 75475
CHU de Toulouse
Toulouse, France, 31052
Hopital des Charpennes
Villeurbanne, France, 69100
Germany
Universitätsklinikum Tübingen
Tübingen, Baden-Württemberg, Germany, 72076
Universitätsklinikum Ulm
Ulm, Baden-Württemberg, Germany, 89081
Studien und Gedächtniszentrum München
München, Bayern, Germany, 80331
Klinikum Rechts der Isar der TU München
München, Bayern, Germany, 81675
Institut fur Psychogerontologie
Nürnberg, Bayern, Germany, 90402
Neurozentrum Prien
Prien am Chiemsee, Bayern, Germany, 83209
Institut für Neuropsychiatrie INP3
Wenzenbach, Bayern, Germany, 93173
Studienzentrum Nord-West
Westerstede, Niedersachsen, Germany, 26655
Praxis Dr. Lauter
Bochum, Nordrhein-Westfalen, Germany, 44787
St Josef-Hospital Bochum
Bochum, Nordrhein-Westfalen, Germany, 44791
Universitätsklinikum Bonn
Bonn, Nordrhein-Westfalen, Germany, 53105
Gemeinschaftspraxis für Neurologie Prof. Gereon Nelles
Köln, Nordrhein-Westfalen, Germany, 50935
Universitätsklinikum Köln
Köln, Nordrhein-Westfalen, Germany, 50937
Neurologische Praxis Siegen
Siegen, Nordrhein-Westfalen, Germany, 57076
Universitätsklinikum des Saarlandes
Homburg, Saarland, Germany, 66421
Martin-Luther-Universität Halle-Wittenberg
Halle (Saale), Sachsen-Anhalt, Germany, 06097
Universitätsklinikum Otto-von-Guericke-Universität
Magdeburg, Sachsen-Anhalt, Germany, 39120
Pharmakologisches Studienzentrum Chemnitz
Mittweida, Sachsen, Germany, 09648
Arztpraxis Dr. Christian Oehlwein
Gera, Thüringen, Germany, 07551
Gemeinschaftspraxis Dr. R. Ehret & Dr. W. von Pannwitz
Berlin, Germany, 12163
Charité Universitätsmedizin Berlin
Berlin, Germany, 12203
Charité Universitätsmedizin Berlin
Berlin, Germany, 13353
Hungary
PTE KK Pszichiatriai es Pszichoterapias Klinika
Pecs, Baranya, Hungary, 7623
Semmelweis Medical University
Budapest, Hungary, 1083
Del-pesti Centrumkorház - Orszagos Hematologiai és Infektologiai Intezet
Budapest, Hungary, 1097
Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz
Debrecen, Hungary, 4031
Debreceni Egyetem Klinikai Kozpont
Debrecen, Hungary, 4032
Univerisity of Szeged
Szeged, Hungary, 6725
Italy
Ospedale Degli Infermi ASR USSL 12
Ponderano (BI), Biella, Italy, 13875
Azienda Ospedaliera San Gerardo
Monza, Milano, Italy, 20900
Fondazione San Raffaele Giglio di Cefalu
Cefalu, Palermo, Italy, 90015
Universita Di Pisa
Pisa, PI, Italy, 56126
Università Politecnica delle Marche Torrette
Ancona, Italy, 60126
IRCCS San Giovanni di Dio Fatebenefratelli
Brescia, Italy, 25125
Fondazione Universitaria degli Studi G D'Annunzio
Chieti, Italy, 66100
Ente Ospedaliero Ospedali Galliera
Genova, Italy, 16132
Fondazione IRCCS Ca'Granda Ospedale Maggiore Policinico
Milano, Italy, 20122
Nuovo Ospedale Civile Sant'Agostino Estense
Modena, Italy, 41010
Policlinico Univ. Agostino Gemelli
Roma, Italy, 00168
Dip.to Med. Sperimentale -Polic.Umberto I -Univ. La Sapienza
Roma, Italy, 00185
Ospedale San Giovanni Calibita Fatebenefratelli
Roma, Italy, 00186
Policlinico Ospedale S. Andrea
Roma, Italy, 00189
Azienda Ospedaliera Citta della Salute della Scienza Torino
Torino, Italy, 10126
Japan
National Institute for Longevity Sciences NCGG
Obu, Aichi, Japan, 474-0038
National Chiba-East-Hospital
Chuo-ku, Chiba, Japan, 260-8712
National Hospital Organization Asahikawa Medical Center
Asahikawa, Hokkaido, Japan, 070-8644
Tsukuba University Hospital
Tsukuba, Ibaraki, Japan, 305-8576
Iwate Medical University Hospital
Morioka, Iwate, Japan, 020-8505
Shonan Kamakura General Hospital
Kamakura, Kanagawa, Japan, 247-8533
Nihon Kokan Hospital
Kawasaki, Kanagawa, Japan, 210-0852
Yokohama City University Hospital
Yokohama, Kanagawa, Japan, 236-0004
Kyoto Prefectural University of Medicine
Kyoto-shi, Kyoto, Japan, 602-8566
Rakuwakai Otowarehabilitation Hospital
Kyoto-shi, Kyoto, Japan, 607-8113
Ina Central Hospital
Ina, Nagano, Japan, 396-8555
Matsumoto Medical Center
Matsumoto, Nagano, Japan, 399-0021
Katayama Medical Clinic
Kurashiki, Okayama, Japan, 701-0192
Shiroma Clinic
Urasoe, Okinawa, Japan, 901-2102
Koshokai aino hospital
Ibaragi, Osaka, Japan, 567-0011
Sakaguchi Clinic
Sakai, Osaka, Japan, 593-8301
National Sanatorium Toneyama Hospital
Toyonaka, Osaka, Japan, 560-8552
Saitama Medical University Hospital
Iruma-Gun, Saitama, Japan, 350-0495
Nippon Medical School Hospital
Bunkyo-Ku, Tokyo, Japan, 113-8603
The University of Tokyo Hospital
Bunkyo-ku, Tokyo, Japan, 113-8655
Nozomi Memory Clinic
Mitaka-shi, Tokyo, Japan, 181-0013
Sangenjaya Nakamura Mental Clinic
Setagaya, Tokyo, Japan, 154-0004
Kanauchi Medical Clinic
Shinjuku-ku, Tokyo, Japan, 160-0023
Tokyo Women's Medical University Hospital
Shinjuku-ku, Tokyo, Japan, 162-8666
Memory Clinic Ochanomizu
Tsukuba, Tokyo, Japan, 305 8576
National Sanatorium Hokuriku Hospital
Nanto, Toyama, Japan, 939-1893
Fukuoka University Hospital
Fukuoka, Japan, 814-0180
Kyoto University Hospital
Kyoto, Japan, 606-8507
Kyoto Minami Hospital
Kyoto, Japan, 610-0113
Utano Hospital
Kyoto, Japan, 616-8255
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, Japan, 545-8586
Korea, Republic of
Dong-A University Medical Center
Seo-gu, Busan, Korea, Republic of, 49201
Seoul National University Bundang Hospital
Seongnam-si, Geonggi-do, Korea, Republic of, 13620
The Catholic University of Korea-Bucheon St. Mary's Hospital
Bucheon-si, Gyeonggi-do, Korea, Republic of, 14647
Hanyang University Guri Hospital
Guri-si, Gyeonggido, Korea, Republic of, 11923
Gachon University Gil Medical Center
Namdong-gu, Incheon, Korea, Republic of, 21565
Asan Medical Center
Songpa-gu, Seoul, Korea, Republic of, 05505
Inha University Hospital
Incheon, Korea, Republic of, 22332
Samsung Medical Center
Seoul, Korea, Republic of, 06351
Seoul St. Mary's Hospital
Seoul, Korea, Republic of, 06591
Poland
NZOZ Wroclawskie Centrum Alzheimerowskie
Wroclaw, Dolnoslaskie, Poland, 53 139
Medycyna Milorzab
Lodz, Lódzkie, Poland, 92216
Podlaskie Centrum Psychogeriatrii
Białystok, Podlaskie, Poland, 15-732
NZOZ Dom Sue Ryder - Pallmed Sp. z o.o.
Bydgoszcz, Poland, 85-796
NZOZ Wielospecjalistyczna Poradnia Lekarska
Katowice, Poland, 40-123
Specjalistyczna Praktyka Lekarska prof. Grzegorz Opala
Katowice, Poland, 40-588
Centrum Zdrowia Psychicznego
Kielce, Poland, 25411
Centrum Neurologii Klinicznej
Krakow, Poland, 31-505
NZOZ Neuromed M. I M. Nastaj sp. P.
Lublin, Poland, 20-064
Instytut Medycyny Wsi
Lublin, Poland, 20-090
NEURO-CARE Sp. z o.o. Sp. Komandytowa
Siemianowice Śląskie, Poland, 41-100
Centrum Medyczne
Warszawa, Poland, 01-697
Centralny Szpital Kliniczny MSW
Warszawa, Poland, 02-507
Puerto Rico
Santa Cruz Behavioral PSC
Bayamon, Puerto Rico, 00961
Ivonne Z. Jimenez-Velazquez, MD
Carolina, Puerto Rico, 00984
Instituto de Neurologia Dra. Ivonne Fraga
San Juan, Puerto Rico, 00918
Michel A. Woodbury-Farina, MD.
San Juan, Puerto Rico, 00918
Romania
SC Med Life SA
Bucuresti, Romania, 010719
SC Centrul Medical Sana SRL
Bucuresti, Romania, 011025
Policlinica CCBR S.R.L.
Bucuresti, Romania, 30463
SC Med Life SA
Timisoara, Romania, 300166
Spain
Hospital General Universitario de Elche
Elche, Alicante, Spain, 03203
Hospital General de Catalunya
Sant Cugat del Valles, Barcelona, Spain, 08190
Hospital Virgen Del Puerto
Plasencia, Caceres, Spain, 10600
Hospital Universitario De Getafe
Madrid, Getafe, Spain, 28905
Hospital Puerta De Hierro
Majadahonda, Madrid, Spain, 28222
Centro de Atencion Especializada (CAE) OROITU
Getxo, Vizcaya, Spain, 48993
Hospital del Mar
Barcelona, Spain, 08003
Hospital Santa Creu I Sant Pau
Barcelona, Spain, 08025
Fundacion ACE-Institut Catala de Neurociences Aplicades
Barcelona, Spain, 08028
Hospital Clinic de Barcelona
Barcelona, Spain, 08036
Hospital Universitari de Bellvitge
Barcelona, Spain, 08907
Hospital Reina Sofia
Cordoba, Spain, 14004
Hospital De La Princesa
Madrid, Spain, 28006
Hospital Universitario Ramon y Cajal
Madrid, Spain, 28034
Hospital Son Espases
Palma de Mallorca, Spain, 07010
Hospital Univ Sant Joan de Reus, S.A.
Reus, Spain, 43204
Fundacion CITA Alzheimer
San Sebastian, Spain, 20009
Hospital Doctor Peset
Valencia, Spain, 46017
Hospital Universitario La Fe de Valencia
Valencia, Spain, 46026
United Kingdom
Plymouth Hospitals NHS Trust
Plymouth, Devon, United Kingdom, PL6 8BX
Cognitive Treatment & Research Unit
Crowborough, East Sussex, United Kingdom, TN6 1HB
Glasgow Memory Clinic
Scotland, Glasgow, United Kingdom, G20 0XA
Southern Health NHS
Southampton, Hampshire, United Kingdom, SO30 3JB
MAC UK Neuroscience Ltd
Lancashire, Lancs, United Kingdom, FY20JH
MAC Clinical Research
Stourton, Leeds, United Kingdom, LS10 1DU
Re-Cognition Health Ltd
Greater London, London, United Kingdom, W1G 9RU
MAC Clinical Research
Cannock, Staffordshire, United Kingdom, WS11 0BN
West London Mental Health NHS Trust
Brentford, United Kingdom, TW8 8DS
Hammersmith Hospital
London, United Kingdom, W12 0NN
Guildford Nuffield Hospital
London, United Kingdom, W1G 9JF
MAC Clinical Research
Manchester, United Kingdom, M13 9NQ
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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02245737     History of Changes
Other Study ID Numbers: 16023
I8D-MC-AZES ( Other Identifier: Eli Lilly and Company )
2014-002601-38 ( EudraCT Number )
D5010C00009 ( Other Identifier: AstraZeneca )
First Posted: September 22, 2014    Key Record Dates
Last Update Posted: October 26, 2018
Last Verified: October 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.


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

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