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

This study is currently recruiting participants.
Verified March 2014 by Eli Lilly and Company
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01900665
First received: July 12, 2013
Last updated: March 14, 2014
Last verified: March 2014
  Purpose

To test the idea that solanezumab will slow the cognitive and functional 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: Safety/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 ]
  • 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 ]

Secondary Outcome Measures:
  • 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 ]
  • 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: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Solanezumab
Solanezumab 400 milligram (mg) every 4 weeks for 18 months.
Drug: Solanezumab
Administered Intravenously (IV)
Other Names:
  • LY2062430
  • A Beta Antibody
Placebo Comparator: Placebo
Placebo every 4 weeks for 18 months.
Drug: Placebo
Administered IV

  Eligibility

Ages Eligible for Study:   55 Years to 90 Years
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01900665

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

  Hide Study Locations
Locations
United States, Arizona
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Litchfield Park, Arizona, United States, 85351
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Phoenix, Arizona, United States, 85006
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Sun City, Arizona, United States, 85351
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Tucson, Arizona, United States, 85714
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Tuscon, Arizona, United States, 85718
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United States, California
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Carson, California, United States, 90746
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Fullerton, California, United States, 92835
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Irvine, California, United States, 92607
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La Jolla, California, United States, 92037
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Laguna Hills, California, United States, 92653
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Lomita, California, United States, 90717
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Long Beach, California, United States, 90813
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Los Angeles, California, United States, 90095
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Newport Beach, California, United States, 92663
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Oxnard, California, United States, 93030
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Redlands, California, United States, 92374
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Sacramento, California, United States, 95817
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San Diego, California, United States, 92103
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San Francisco, California, United States, 94158
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Santa Ana, California, United States, 92705
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Santa Monica, California, United States, 90404
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Santa Rosa, California, United States, 95403
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Sherman Oaks, California, United States, 91403
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United States, Colorado
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Denver, Colorado, United States, 80239
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United States, Connecticut
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Fairfield, Connecticut, United States, 06824
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Hamden, Connecticut, United States, 06518
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New Haven, Connecticut, United States, 06520
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Norwalk, Connecticut, United States, 06851
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United States, Delaware
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Newark, Delaware, United States, 19713
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United States, District of Columbia
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Washington, District of Columbia, United States, 20057
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United States, Florida
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Boca Raton, Florida, United States, 33486
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Deerfield Beach, Florida, United States, 33064
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Delray Beach, Florida, United States, 33446
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Fort Myers, Florida, United States, 33912
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Hallandale Beach, Florida, United States, 33009
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Hollywood, Florida, United States, 33021
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Jacksonville, Florida, United States, 32224
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Miami, Florida, United States, 33175
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Miami Springs, Florida, United States, 33166
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Ocala, Florida, United States, 34471
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Orlando, Florida, United States, 32806
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Sunrise, Florida, United States, 33351
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Tampa, Florida, United States, 33613
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West Palm Beach, Florida, United States, 33407
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United States, Georgia
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Atlanta, Georgia, United States, 30341
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United States, Illinois
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Chicago, Illinois, United States, 60612
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Elk Grove Village, Illinois, United States, 60007
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United States, Indiana
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Indianapolis, Indiana, United States, 46202
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United States, Kansas
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Kansas City, Kansas, United States, 66160
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Manhattan, Kansas, United States, 66502
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Prairie Village, Kansas, United States, 66206
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Wichita, Kansas, United States, 67214
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United States, Kentucky
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Lexington, Kentucky, United States, 40503
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United States, Louisiana
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New Orleans, Louisiana, United States, 70114
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Shreveport, Louisiana, United States, 71104
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United States, Maine
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Auburn, Maine, United States, 04210
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Scarborough, Maine, United States, 04074
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United States, Maryland
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Baltimore, Maryland, United States, 21285
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United States, Massachusetts
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Belmont, Massachusetts, United States, 02478
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Boston, Massachusetts, United States, 02118
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Brockton, Massachusetts, United States, 02301
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Methuen, Massachusetts, United States, 01844
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Newton, Massachusetts, United States, 02459
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United States, Michigan
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Traverse City, Michigan, United States, 49684
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United States, Mississippi
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Hattiesburg, Mississippi, United States, 39402
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United States, Missouri
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St Louis, Missouri, United States, 63118
Contact: Eli Lilly         
United States, Nebraska
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Omaha, Nebraska, United States, 68198
Contact: Eli Lilly         
United States, Nevada
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Las Vegas, Nevada, United States, 89113
Contact: Eli Lilly         
United States, New Jersey
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Lawrenceville, New Jersey, United States, 08648
Contact: Eli Lilly         
United States, New Mexico
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Albuquerque, New Mexico, United States, 87109
Contact: Eli Lilly         
United States, New York
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Albany, New York, United States, 12206
Contact: Eli Lilly         
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Amherst, New York, United States, 14226
Contact: Eli Lilly         
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Brooklyn, New York, United States, 11235
Contact: Eli Lilly         
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New York, New York, United States, 10032
Contact: Eli Lilly         
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Staten Island, New York, United States, 10312
Contact: Eli Lilly         
United States, North Carolina
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Charlotte, North Carolina, United States, 28211
Contact: Eli Lilly         
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Greensboro, North Carolina, United States, 27405
Contact: Eli Lilly         
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Raleigh, North Carolina, United States, 27612
Contact: Eli Lilly         
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Washington, North Carolina, United States, 27103
Contact: Eli Lilly         
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Winston-Salem, North Carolina, United States, 27103
Contact: Eli Lilly         
United States, Ohio
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Centerville, Ohio, United States, 45459
Contact: Eli Lilly         
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Columbus, Ohio, United States, 43210
Contact: Eli Lilly         
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Dayton, Ohio, United States, 45417
Contact: Eli Lilly         
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Shaker Heights, Ohio, United States, 44122
Contact: Eli Lilly         
United States, Oklahoma
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Oklahoma City, Oklahoma, United States, 73116
Contact: Eli Lilly         
United States, Oregon
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Corvallis, Oregon, United States, 97330
Contact: Eli Lilly         
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Portland, Oregon, United States, 97210
Contact: Eli Lilly         
United States, Pennsylvania
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Allentown, Pennsylvania, United States, 18104
Contact: Eli Lilly         
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Philadelphia, Pennsylvania, United States, 19102
Contact: Eli Lilly         
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Pittsburgh, Pennsylvania, United States, 15213
Contact: Eli Lilly         
United States, Rhode Island
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East Providence, Rhode Island, United States, 02914
Contact: Eli Lilly         
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Providence, Rhode Island, United States, 02906
Contact: Eli Lilly         
United States, South Carolina
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Charleston, South Carolina, United States, 29401
Contact: Eli Lilly         
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Greer, South Carolina, United States, 29651
Contact: Eli Lilly         
United States, South Dakota
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Sioux Falls, South Dakota, United States, 57105
Contact: Eli Lilly         
United States, Tennessee
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Johnson City, Tennessee, United States, 37604
Contact: Eli Lilly         
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. Recruiting
Nashville, Tennessee, United States, 37212
Contact: Eli Lilly         
United States, Texas
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Dallas, Texas, United States, 75235
Contact: Eli Lilly         
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. Recruiting
San Antonio, Texas, United States, 78205
Contact: Eli Lilly         
United States, Utah
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Murray, Utah, United States, 84123
Contact: Eli Lilly         
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Salt Lake City, Utah, United States, 84132
Contact: Eli Lilly         
United States, Vermont
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Bennington, Vermont, United States, 05201
Contact: Eli Lilly         
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. Not yet recruiting
Burlington, Vermont, United States, 05401
Contact: Eli Lilly         
United States, Virginia
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. Recruiting
Norfolk, Virginia, United States, 23502
Contact: Eli Lilly         
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. Recruiting
Richmond, Virginia, United States, 23294
Contact: Eli Lilly         
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. Recruiting
Roanoke, Virginia, United States, 24018
Contact: Eli Lilly         
United States, Washington
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Seattle, Washington, United States, 98108
Contact: Eli Lilly         
United States, Wisconsin
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Madison, Wisconsin, United States, 53705
Contact: Eli Lilly         
Australia, New South Wales
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Darlinghurst, New South Wales, Australia, 2010
Contact: Eli Lilly         
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. Recruiting
East Gosford, New South Wales, Australia, 2250
Contact: Eli Lilly         
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. Recruiting
Kogarah, New South Wales, Australia, 2217
Contact: Eli Lilly         
Australia, Queensland
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Chermside, Queensland, Australia, 4032
Contact: Eli Lilly         
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. Recruiting
Herston, Queensland, Australia, 4029
Contact: Eli Lilly         
Australia, Victoria
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Box Hill, Victoria, Australia, 3128
Contact: Eli Lilly         
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Caulfield, Victoria, Australia, 3162
Contact: Eli Lilly         
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. Recruiting
Fitzroy, Victoria, Australia, 3065
Contact: Eli Lilly         
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. Recruiting
Heidelberg, Victoria, Australia, 3081
Contact: Eli Lilly         
Australia, Western Australia
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Subiaco, Western Australia, Australia, 06008
Contact: Eli Lilly         
Canada, Alberta
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Medicine Hat, Alberta, Canada, T1B4E7
Contact: Eli Lilly         
Canada, Ontario
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London, Ontario, Canada, N6C 5J1
Contact: Eli Lilly         
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. Recruiting
Ottawa, Ontario, Canada, K1N 5C8
Contact: Eli Lilly         
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. Recruiting
Peterborough, Ontario, Canada, K9H2P4
Contact: Eli Lilly         
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. Recruiting
Toronto, Ontario, Canada, M6M 3Z5
Contact: Eli Lilly         
Canada, Quebec
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Gatineau, Quebec, Canada, J9A 1K7
Contact: Eli Lilly         
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. Recruiting
Greenfield Park, Quebec, Canada, J4V 2J2
Contact: Eli Lilly         
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. Recruiting
Sherbrooke, Quebec, Canada, J1H1Z1
Contact: Eli Lilly         
France
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. Recruiting
Bron, France, 69677
Contact: Eli Lilly         
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. Recruiting
Dijon, France, 21033
Contact: Eli Lilly         
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. Recruiting
Lille, France, 59037
Contact: Eli Lilly         
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. Recruiting
Marseille, France, 13385
Contact: Eli Lilly         
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. Recruiting
Montpellier, France, 34295
Contact: Eli Lilly         
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. Recruiting
Paris, France, 75010
Contact: Eli Lilly         
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. Recruiting
Reims, France, 51092
Contact: Eli Lilly         
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. Recruiting
Rennes, France, 35033
Contact: Eli Lilly         
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. Recruiting
Strasbourg, France, 67098
Contact: Eli Lilly         
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. Recruiting
Toulouse, France, 31059
Contact: Eli Lilly         
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. Recruiting
Villeurbanne, France, 69100
Contact: Eli Lilly         
Germany
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. Not yet recruiting
Bamberg, Germany, 96047
Contact: Eli Lilly         
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. Recruiting
Berlin, Germany, 14050
Contact: Eli Lilly         
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. Recruiting
Boeblingen, Germany, 71034
Contact: Eli Lilly         
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. Recruiting
Dresden, Germany, 01307
Contact: Eli Lilly         
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. Recruiting
Hannover, Germany, 30559
Contact: Eli Lilly         
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. Recruiting
Mannheim, Germany, 68165
Contact: Eli Lilly         
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. Recruiting
Munich, Germany, 81675
Contact: Eli Lilly         
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. Recruiting
Siegen, Germany, 57076
Contact: Eli Lilly         
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. Recruiting
Ulm, Germany, 89081
Contact: Eli Lilly         
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. Recruiting
Westerstede, Germany, 26655
Contact: Eli Lilly         
Italy
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. Recruiting
Biella, Italy, 13900
Contact: Eli Lilly         
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. Recruiting
Firenze, Italy, 50134
Contact: Eli Lilly         
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. Not yet recruiting
Genova, Italy, 16128
Contact: Eli Lilly         
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. Recruiting
Milano, Italy, 20122
Contact: Eli Lilly         
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. Recruiting
Perugia, Italy, 06156
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Pisa, Italy, 56126
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Rome, Italy, 00179
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Torino, Italy, 10126
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Japan
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Aichi, Japan, 474-8511
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Hyogo, Japan, 655-0037
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Ibaraki, Japan, 305-8576
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Kanagawa, Japan, 247-8533
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Kyoto, Japan, 616-8255
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Kyoto-Fu, Japan, 600-8558
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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
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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
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Spain
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Barakaldo, Spain, 48903
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Barcelona, Spain, 08242
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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
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Sweden
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Jönköping, Sweden, 55185
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Kalmar, Sweden, SE-39185
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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
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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
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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

No publications provided

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: March 14, 2014
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

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014