Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Progress of Mild Alzheimer's Disease in Participants on Solanezumab Versus Placebo (EXPEDITION 3)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01900665
First received: July 12, 2013
Last updated: November 30, 2016
Last verified: November 2016
  Purpose
To test the idea that solanezumab will slow the cognitive decline of Alzheimer's Disease (AD) as compared with placebo in participants with mild AD.

Condition Intervention Phase
Alzheimer's Disease
Drug: Solanezumab
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Passive Immunization on the Progression of Mild Alzheimer's Disease: Solanezumab (LY2062430) Versus Placebo

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Change from Baseline in Alzheimer's Disease Assessment Scale-Cognitive 14 Item Subscore (ADAS-Cog14) [ Time Frame: Baseline, Week 80 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from Baseline in Alzheimer's Disease Cooperative Study- Instrumental Activities of Daily Living (ADCS-iADL) [ Time Frame: Baseline, Week 80 ] [ Designated as safety issue: No ]
  • Change from Baseline in Alzheimer's Disease Assessment Scale-Cognitive 11 Item Subscore (ADAS-Cog11) [ Time Frame: Baseline, Week 80 ] [ Designated as safety issue: No ]
  • Change from Baseline in Mini-Mental State Examination (MMSE) [ Time Frame: Baseline, Week 80 ] [ Designated as safety issue: No ]
  • Change from Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) [ Time Frame: Baseline, Week 80 ] [ Designated as safety issue: No ]
  • Change from Baseline in Functional Activities Questionnaire (FAQ) [ Time Frame: Baseline, Week 80 ] [ Designated as safety issue: No ]
  • Change from Baseline in Clinical Dementia Rating-Sum of Boxes (CDR-SB) [ Time Frame: Baseline, Week 80 ] [ Designated as safety issue: No ]
  • Change from Baseline in Neuropsychiatric Inventory (NPI) [ Time Frame: Baseline, Week 80 ] [ Designated as safety issue: No ]
  • Change from Baseline in Resource Utilization in Dementia-Lite (RUD-Lite) [ Time Frame: Baseline, Week 80 ] [ Designated as safety issue: No ]
  • Change from Baseline in Quality of Life in Alzheimer's Disease (QoL-AD) [ Time Frame: Baseline, Week 80 ] [ Designated as safety issue: No ]
  • Change from Baseline in 5-Dimensional EuroQol Quality of Life Scale Proxy Version (EQ-5D Proxy) [ Time Frame: Baseline, Week 80 ] [ Designated as safety issue: No ]
  • Change from Baseline in Integrated Alzheimer's Disease Rating Scale (iADRS) [ Time Frame: Baseline, Week 80 ] [ Designated as safety issue: No ]
  • Proportion of Cognitive and Functional Responders [ Time Frame: Baseline through Week 80 ] [ Designated as safety issue: No ]
  • Change from Baseline in Plasma Amyloid-Beta (Aβ) Species [ Time Frame: Baseline, Week 80 ] [ Designated as safety issue: No ]
  • Change from Baseline in volumetric Magnetic Resonance Imaging (vMRI) [ Time Frame: Baseline, Week 80 ] [ Designated as safety issue: No ]
  • Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of Solanezumab (LY2062430) [ Time Frame: Baseline through Week 80 ] [ Designated as safety issue: No ]
  • Change from Baseline in Florbetapir Positron Emission Tomography (PET) Scan [ Time Frame: Baseline, Week 80 ] [ Designated as safety issue: No ]
  • Change from Baseline in Cerebrospinal Fluid (CSF) Aβ Levels [ Time Frame: Baseline, Week 80 ] [ Designated as safety issue: No ]

Estimated Enrollment: 2100
Study Start Date: July 2013
Estimated Study Completion Date: February 2017
Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Solanezumab
Solanezumab 400 milligrams (mg) every 4 weeks for 76 weeks with an additional 4 weeks of assessments. Participants who complete the full 80 weeks of treatment/assessment and decide to continue will take this regimen for up to an additional 208 weeks.
Drug: Solanezumab
Administered Intravenously (IV)
Other Names:
  • LY2062430
  • A Beta Antibody
Placebo Comparator: Placebo
Placebo every 4 weeks for 76 weeks with an additional 4 weeks of assessments. Participants who complete the full 80 weeks of treatment/assessment and decide to continue will switch to solanezumab 400 mg every 4 weeks for up to an additional 208 weeks.
Drug: Placebo
Administered IV

  Eligibility

Ages Eligible for Study:   55 Years to 90 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Meets National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria for probable AD
  • Has a Modified Hachinski Ischemia Scale score of less than or equal to 4
  • Has a Mini-Mental State Examination (MMSE) score of 20 through 26 at Screening visit
  • Has a Geriatric Depression Scale score of less than or equal to 6 (on the staff-administered short form)
  • Has had a magnetic resonance imaging (MRI) or computerized tomography (CT) scan performed within the past 2 years that has confirmed no findings inconsistent with a diagnosis of AD
  • Has a florbetapir positron emission tomography (PET) scan or cerebrospinal fluid (CSF) result consistent with the presence of amyloid pathology at screening

Exclusion Criteria:

  • Does not have a reliable caregiver who is in frequent contact with the participant (defined as at least 10 hours per week), will accompany the participant to the office and/or be available by telephone at designated times, and will monitor administration of prescribed medications
  • Meets National Institute of Neurological Disorders and Stroke/Association Internationale pour la Recherche et l'Enseignement en Neurosciences (NINDS/AIREN) criteria for vascular dementia
  • Has current serious or unstable illnesses including cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic (other than AD), psychiatric, immunologic, or hematologic disease and other conditions that, in the investigator's opinion, could interfere with the analyses of safety and efficacy in this study; or has a life expectancy of <2 years
  • Has had a history within the last 5 years of a serious infectious disease affecting the brain or head trauma resulting in protracted loss of consciousness
  • Has a history within the last 5 years of a primary or recurrent malignant disease with the exception of resected cutaneous squamous cell carcinoma in situ, basal cell carcinoma, cervical carcinoma in situ, or in situ prostate cancer with a normal prostate-specific antigen posttreatment
  • Has a known history of human immunodeficiency virus (HIV), clinically significant multiple or severe drug allergies, or severe posttreatment hypersensitivity reactions
  • Has received acetylcholinesterase inhibitor (AChEIs), memantine and/or other AD therapy for less than 4 months or has less than 2 months of stable therapy on these treatments
  • Has received medications that affect the central nervous system (CNS), except treatments for AD, for less than 4 weeks
  • Has a history of chronic alcohol or drug abuse/dependence within the past 5 years
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01900665

  Hide Study Locations
Locations
United States, Arizona
Xenoscience
Phoenix, Arizona, United States, 85004
Banner Alzheimer's Institute
Phoenix, Arizona, United States, 85006
St Josephs Hospital and Medical Center
Phoenix, Arizona, United States, 85013
ANI Arizona Neurological Institute Research, PC
Sun City, Arizona, United States, 85351
Banner Sun Health Research Institute
Sun City, Arizona, United States, 85351
Center for Neurosciences
Tucson, Arizona, United States, 85718
Arizona Health Sciences Center
Tuscon, Arizona, United States, 85724
United States, California
American Neuropsychiatric Research Institute, Inc
Carson, California, United States, 90746
Neurology Center of North Orange County
Fullerton, California, United States, 92835
Institute for Memory Impairment & Neurological Disorders
Irvine, California, United States, 92697
University of California - San Diego
La Jolla, California, United States, 92037
Senior Clinical Trials, Inc.
Laguna Hills, California, United States, 92653
Torrance Clinical Research
Lomita, California, United States, 90717
Collaborative Neuroscience Network - CNS
Long Beach, California, United States, 90806
Apostle Clinical Trials, Inc
Long Beach, California, United States, 90813
Univ of Southern California Medical Center
Los Angeles, California, United States, 90033
University of California Los Angeles School of Medicine
Los Angeles, California, United States, 90073
UCLA Medical Center
Los Angeles, California, United States, 90095
Hoag Memorial Hospital
Newport Beach, California, United States, 92663
Pacific Neuroscience Medical Group
Oxnard, California, United States, 93030
Anderson Clinical Research
Redlands, California, United States, 92374
University of California, Davis - Health Systems
Sacramento, California, United States, 95817
Artemis Institute for Clinical Research
San Diego, California, United States, 92103
Pacific Research Network Inc
San Diego, California, United States, 92103
Sharp Mesa Vista Hospital
San Diego, California, United States, 92123
San Francisco Clinical Research Center
San Francisco, California, United States, 94109
University of California, San Francisco
San Francisco, California, United States, 94158
Apex Research Institute
Santa Ana, California, United States, 92705
St. Joseph Health
Santa Rosa, California, United States, 95403
California Neuroscience Research
Sherman Oaks, California, United States, 91403
United States, Colorado
Radiant Research
Denver, Colorado, United States, 80239
United States, Connecticut
Associated Neurologists of Southern Connecticut
Fairfield, Connecticut, United States, 06824
Institute for Neurodegenerative Disorders
New Haven, Connecticut, United States, 06510
Yale University School of Medicine
New Haven, Connecticut, United States, 06520-8020
Research Center for Clinical Studies
Norwalk, Connecticut, United States, 06851
United States, Delaware
Christiana Care Research Institute
Newark, Delaware, United States, 19713
United States, District of Columbia
Georgetown University Hospital
Washington, District of Columbia, United States, 20057
United States, Florida
Parkinson's Disease and Movement Disorders
Boca Raton, Florida, United States, 33486
Quantum Laboratories
Deerfield Beach, Florida, United States, 33064
Cohen Medical Associates P.A.
Delray Beach, Florida, United States, 33446
Brain Matters Research
Delray, Florida, United States, 33445
Neuropsychiatric Research Center of Southwest Florida
Fort Myers, Florida, United States, 33912
MD Clinical
Hallandale Beach, Florida, United States, 33009
Galiz Research
Hialeah, Florida, United States, 33016
Infinity Clinical Research . LLC
Hollywood, Florida, United States, 33021
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States, 32216
Mayo Clinic of Jacksonville
Jacksonville, Florida, United States, 32224
Miami Jewish Home and Hospital for the Aged
Miami, Florida, United States, 33137
Renstar Medical Research
Ocala, Florida, United States, 34471
Compass Research
Orlando, Florida, United States, 32806
Neurology Clinical Research, Inc
Sunrise, Florida, United States, 33351-6637
Axiom Research
Tampa, Florida, United States, 33609
Stedman Clinical Trials
Tampa, Florida, United States, 33613
University of South Florida
Tampa, Florida, United States, 33613
Premiere Research Institute at Palm Beach Neurology
West Palm Beach, Florida, United States, 33407
United States, Georgia
Atlanta Center of Medical Research
Atlanta, Georgia, United States, 30331
United States, Illinois
Rush Alzheimer's Disease Center
Chicago, Illinois, United States, 60612
Alexian Brothers Medical Center
Elk Grove Village, Illinois, United States, 60007
United States, Indiana
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
CTT Consultants
Prairie Village, Kansas, United States, 66206
Heartland Research Associates
Wichita, Kansas, United States, 67207
Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
United States, Kentucky
Baptist Physician's Lexington
Lexington, Kentucky, United States, 40503
United States, Louisiana
Private Office: J. Gary Booker
Shreveport, Louisiana, United States, 71104
United States, Maine
Maine Research Associates
Auburn, Maine, United States, 04210
Maine Neurology
Scarborough, Maine, United States, 04074
United States, Maryland
PharmaSite Research Inc
Baltimore, Maryland, United States, 21208
United States, Massachusetts
McLean Hospital
Belmont, Massachusetts, United States, 02478
Brigham and Womens Hospital
Boston, Massachusetts, United States, 02115
Boston University Medical Center
Boston, Massachusetts, United States, 02118
ActivMed Practices & Research, Inc
Methuen, Massachusetts, United States, 01844
Boston Center for Memory
Newton, Massachusetts, United States, 02459
United States, Michigan
Northern Michigan Neurology
Traverse City, Michigan, United States, 49684
United States, Mississippi
Hattiesburg Clinic
Hattiesburg, Mississippi, United States, 39401
United States, Nebraska
Univ of Nebraska Med Center
Omaha, Nebraska, United States, 68198
United States, Nevada
Cleveland Clinic of Las Vegas
Las Vegas, Nevada, United States, 89106
Las Vegas Radiology
Las Vegas, Nevada, United States, 89113
United States, New Jersey
AdvanceMed Research
Lawrenceville, New Jersey, United States, 08648
United States, New Mexico
Albuquerque Neurosciences
Albuquerque, New Mexico, United States, 87109
United States, New York
Albany Medical College
Albany, New York, United States, 12206
Dent Neurological Institute
Amherst, New York, United States, 14226
SPRI Clinical Trials, LLC.
Brooklyn, New York, United States, 11235
New York University Medical Center
New York, New York, United States, 10016
Mount Sinai Medical Center
New York, New York, United States, 10029-6574
Columbia University Medical Center
New York, New York, United States, 10032
Richmond Behavorial Associates
Staten Island, New York, United States, 10312
United States, North Carolina
PMG Research of Charlotte, LLC
Charlotte, North Carolina, United States, 28203
Behavioral Health Center Research
Charlotte, North Carolina, United States, 28211
Guilford Neurologic Associates
Greensboro, North Carolina, United States, 27405
Wake Research Associates
Raleigh, North Carolina, United States, 27612
PMG Research of Winston-Salem, LLC
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Valley Medical Research
Centerville, Ohio, United States, 45459
Ohio State Univ College Of Medicine
Columbus, Ohio, United States, 43210
Neurology Specialists Inc.
Dayton, Ohio, United States, 45417
Insight Clinical Trials
Shaker Heights, Ohio, United States, 44122
United States, Oklahoma
Red River Medical Center, LLC
Oklahoma City, Oklahoma, United States, 73112
Cutting Edge Research Group
Oklahoma City, Oklahoma, United States, 73116
United States, Oregon
The Corvallis Clinic P.C.
Corvallis, Oregon, United States, 97330
Summit Research Network Inc
Portland, Oregon, United States, 97210
United States, Pennsylvania
Drexel University College of Medicine at EPPI
Philadelphia, Pennsylvania, United States, 19102
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
United States, Rhode Island
Rhode Island Mood & Memory Research Institute
East Providence, Rhode Island, United States, 02914
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Butler Hospital
Providence, Rhode Island, United States, 02906
United States, South Carolina
Roper St. Francis Healthcare
Charleston, South Carolina, United States, 29401
Radiant Research
Greer, South Carolina, United States, 29651
United States, South Dakota
University Psychiatry Associates Avera Health
Sioux Falls, South Dakota, United States, 57105
United States, Tennessee
Quillen College of Medicine, East TN State University
Johnson City, Tennessee, United States, 37604
Vanderbilt Univeristy School of Medicine
Nashville, Tennessee, United States, 37212
United States, Texas
Texas Neurology, PA
Dallas, Texas, United States, 75214
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75390
Diagnostic Research Group
San Antonio, Texas, United States, 78229
United States, Utah
Radiant Research
Murray, Utah, United States, 84123
University of Utah School of Medicine
Salt Lake City, Utah, United States, 84108
United States, Vermont
The Memory Clinic
Bennington, Vermont, United States, 05201
United States, Virginia
National Clinical Research - Norfolk Inc
Norfolk, Virginia, United States, 23502
National Clinical Research - Richmond
Richmond, Virginia, United States, 23294
Blue Ridge Research Center
Roanoke, Virginia, United States, 24018
United States, Washington
Veterans Affairs Puget Sound Health Care System
Seattle, Washington, United States, 98108
Australia, New South Wales
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.
Darlinghurst, New South Wales, Australia, 2010
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East Gosford, New South Wales, Australia, 2250
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Kogarah, New South Wales, Australia, 2217
Australia, Victoria
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Box Hill, Victoria, Australia, 3128
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Caulfield, Victoria, Australia, 3162
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Fitzroy, Victoria, Australia, 3065
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Heidelberg, Victoria, Australia, 3081
Australia, Western Australia
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Subiaco, Western Australia, Australia, 06008
Canada, Ontario
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London, Ontario, Canada, N6C 5J1
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Ottawa, Ontario, Canada, K1N 5C8
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Peterborough, Ontario, Canada, K9H2P4
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Toronto, Ontario, Canada, M4G 3E8
Canada, Quebec
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Gatineau, Quebec, Canada, J8T 8J1
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Greenfield Park, Quebec, Canada
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Sherbrooke, Quebec, Canada, J1H1Z1
France
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Bron, France, 69677
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Dijon, France, 21033
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Lille, France, 59037
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Marseille, France, 13385
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Montpellier, France, 34295
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Paris, France, 75013
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Reims, France, 51092
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Rennes, France, 35033
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Strasbourg, France, 67098
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Toulouse, France, 31059
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Villeurbanne, France, 69100
Germany
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Berlin, Germany, 12203
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Boeblingen, Germany, 71034
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Hannover, Germany, 30559
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Mannheim, Germany, 68165
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Munich, Germany, 81675
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Siegen, Germany, 57076
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Ulm, Germany, 89081
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Westerstede, Germany, 26655
Italy
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Firenze, Italy, 50134
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Genova, Italy, 16128
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Milano, Italy, 20122
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Pisa, Italy, 56126
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Ponderano (BI), Italy, 13875
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Rome, Italy, 00161
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Torino, Italy, 10126
Japan
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Aichi, Japan, 474-8511
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Hyogo, Japan, 670-0981
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Ibaraki, Japan, 305-8576
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Kanagawa, Japan, 247-8533
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Kobe, Japan, 655-0037
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Kyoto, Japan, 616-8255
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Osaka, Japan, 545-8586
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Shizuoka, Japan, 424-8636
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Tokushima, Japan, 770-8503
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Tokyo, Japan, 187-8551
Poland
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Bydgoszcz, Poland, 85-796
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Katowice, Poland, 40-588
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Krakow, Poland, 31-505
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Sopot, Poland, 81-824
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Szczecin, Poland, 70-215
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Warsaw, Poland, 01-813
Spain
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Barakaldo, Spain, 48903
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Barcelona, Spain, 08014
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Getafe, Spain, 28905
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Guipuzcoa, Spain, 20014
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Madrid, Spain, 28006
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Plasencia, Spain, 10600
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Salt-Girona, Spain, 17190
Sweden
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Jönköping, Sweden, 55185
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Malmo, Sweden, 212 24
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Molndal, Sweden, 431 41
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Stockholm, Sweden, 14186
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Umea, Sweden, 90185
United Kingdom
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Bath, Avon, United Kingdom, BA1 3NG
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Plymouth, Devon, United Kingdom, PL6 8BX
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Crowborough, East Sussex, United Kingdom, TN6 1HB
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Scotland, Glasgow, United Kingdom, G20 0XA
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Greater London, London, United Kingdom, W1G9JF
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Salford, Manchester, United Kingdom, M6 8HD
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Swindon, Wiltshire, United Kingdom, SN3 6BW
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Glasgow, United Kingdom, G31 2ER
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Newcastle, United Kingdom, NE4 5PL
Sponsors and Collaborators
Eli Lilly and Company
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
  More Information

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01900665     History of Changes
Other Study ID Numbers: 15136  H8A-MC-LZAX 
Study First Received: July 12, 2013
Last Updated: November 30, 2016
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Canada: Health Canada
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Paul-Ehrlich-Institut
Italy: The Italian Medicines Agency
Japan: Pharmaceuticals and Medical Devices Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration
Individual Participant Data  
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.


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

ClinicalTrials.gov processed this record on December 09, 2016