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

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ClinicalTrials.gov Identifier: NCT02245737
Recruitment Status : Active, not recruiting
First Posted : September 22, 2014
Last Update Posted : March 23, 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)
Estimated Enrollment : 2202 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)
Study Start Date : September 2014
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

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 ]


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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
Howard University Hospital
Washington, District of Columbia, United States, 20060
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 Home and Hospital for the Aged
Miami, Florida, United States, 33137
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, 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
Olympian Clinical Research
Tampa, Florida, United States, 33609
Stedman Clinical Trials
Tampa, Florida, United States, 33613
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
Carmen 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
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
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
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, 37604
Quillen College Of Medicine
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
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
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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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Camberwell, Australia, 3124
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Glen Iris, Australia, 3146
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Gold Coast, Australia, 4222
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Heidelberg, Australia, 3081
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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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Parkerville, Australia, 3052
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Southport, Australia, 4215
Belgium
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Brussels, Belgium, 1020
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Brussels, Belgium, 1200
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Brussel, Belgium, 1070
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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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Gatineau, Canada, J8T 8J1
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Greenfield Park, Canada, J4V 2J2
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Halifax, Canada, B3S1M7
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Kamloops, Canada, V2C 1K7
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Kelowna, Canada, V1Y 1Z9
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Montreal, Canada, H1T 2M4
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Ottawa, Canada, K1N 5C8
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Peterborough, Canada, K9H2P4
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Quebec City, Canada, G1J 1Z4
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Sherbrooke, Canada, J1J 2G2
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Sherbrooke, Canada, J1J3H5
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Toronto, Canada, M3B2S7
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Toronto, Canada, M5T2S8
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Vancouver, Canada, V6T 2B5
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Victoria, Canada, V8R 158
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Victoria, Canada, v8r158
France
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Bron, France, 69677
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Dijon, France, 21033
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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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Nantes, France, 44093
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Paris, France, 75013
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Paris, France, 75475
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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, 83209
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Berlin, Germany, 12203
Charité Universitätsmedizin Berlin
Berlin, Germany, 12203
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Berlin, Germany, 13353
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Bochum, Germany, 44791
Universitätsklinikum Bonn
Bonn, Germany, 53105
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Gera, Germany, 07551
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Halle, Germany, 06097
Universitätsklinikum des Saarlandes
Homburg, Germany, 66421
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Köln, Germany, 50935
Universitätsklinikum Köln AöR
Köln, Germany, 50937
Otto-von Guericke Universität Magdeburg
Magdeburg, Germany, 39120
Pharmakologisches Studienzentrum Chemnitz GmbH
Mittweida, Germany, 09648
Praxis Eisensehr/Karlbauer/Pauls
München, Germany, 80331
Klinikum rechts der Isar der TU München
München, Germany, 81675
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Nürnberg, Germany, 90402
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Siegen, Germany, 57076
Universitätsklinikum Tübingen
Tübingen, Germany, 72076
Universitätsklinikum Ulm
Ulm, Germany, 89081
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Wenzenbach, Germany, 93173
Fachübergreifende Gemeinschaftspraxis für Neurologie und Psychiatrie
Westerstede, Germany, 26655
Hungary
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Budapest, Hungary, 1083
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Budapest, Hungary, 1096
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Budapest, Hungary, 1097
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Debrecen, Hungary, 4031
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Debrecen, Hungary, 4032
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Debrecen, Hungary, 4043
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Pecs, Hungary, 7623
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Szeged, Hungary, 6725
Italy
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Ancona, Italy, 60126
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Brescia, Italy, 25125
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Cefalu, Italy, 90015
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Chieti, Italy, 66100
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Genova, Italy, 16132
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Milano, Italy, 20122
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Modena, Italy, 41010
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Monza, Italy, 20900
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Pisa, Italy, 56126
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Ponderano, Italy, 13875
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Roma, Italy, 00168
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Roma, Italy, 00185
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Roma, Italy, 00186
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Roma, Italy, 00189
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Torino, Italy, 10126
Japan
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Tokyo, Tsukuba, Japan, 305 8576
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Asahikawa, Japan, 070-8644
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Bunkyo-Ku, Japan, 113-8603
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Bunkyo-ku, Japan, 113-8655
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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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Kanagawa, Japan, 210-0852
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Kanagawa, 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, 6028566
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Kyoto, Japan, 606-8507
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Kyoto, Japan, 607-8113
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Kyoto, Japan, 6078113
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Kyoto, Japan, 610-0113
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Kyoto, Japan, 616-8255
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Matsumoto, Japan, 399-0021
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Matsumoto, Japan, 3990021
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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, 162-8666
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Shinjuku, Japan, 162-0064
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Tokyo, Japan, 113-8655
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Tokyo, Japan, 1600023
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Tokyo, Japan, 181-0013
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Tokyo, Japan, 1810013
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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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Guri, Korea, Republic of, 11923
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Incheon, Korea, Republic of, 22332
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Namdong-gu, Korea, Republic of, 21565
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Seo-gu, Korea, Republic of, 49201
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Seongnam, 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, 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, 25411
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Kraków, Poland, 31-505
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Lodz, Poland, 92216
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Lubin, Poland, 53 139
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Lublin, Poland, 20-090
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Warszawa, Poland, 01-697
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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
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Bucuresti, Romania, 010719
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Bucuresti, Romania, 011025
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Bucuresti, Romania, 30463
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Timisoara, Romania, 300166
Spain
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Barcelona, Spain, 08003
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Barcelona, Spain, 08025
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Barcelona, Spain, 08028
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Barcelona, Spain, 08036
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Barcelona, Spain, 08907
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Cordoba, Spain, 14004
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Elche, Spain, 03203
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Elche, Spain, 03203
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Getxo, Spain, 48993
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Madrid, Spain, 28006
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Madrid, Spain, 28024
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Madrid, Spain, 28034
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Madrid, Spain, 28905
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Majadahonda, Spain, 28222
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Manresa, Spain, 08243
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Palma de Mallorca, Spain, 07010
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Plasencia, Spain, 10600
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Reus, Spain, 43204
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San Sebastián, Spain, 20009
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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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Greater London, United Kingdom, W1G 9RU
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Isleworth, United Kingdom, TW7 6FY
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London, United Kingdom, W12 0NN
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London, United Kingdom, W1G 9JF
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Plymouth, United Kingdom, PL6 8BX
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Southampton, United Kingdom, SO30 3JB
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Stourton, 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:
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: March 23, 2018
Last Verified: March 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