A Study of LY3202626 on Disease Progression in Participants With Mild Alzheimer's Disease Dementia
NCT ID: NCT02791191
Last Updated: 2021-04-19
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
316 participants
INTERVENTIONAL
2016-06-16
2018-07-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Dose 1 LY3202626
3 mg LY3202626 given orally once daily for 52 weeks.
LY3202626
Administered orally
Dose 2 LY3202626
12 mg LY3202626 given orally once daily for 52 weeks.
LY3202626
Administered orally
Placebo
Placebo given orally once daily for 52 weeks.
Placebo
Administered orally
Interventions
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LY3202626
Administered orally
Placebo
Administered orally
Eligibility Criteria
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Inclusion Criteria
* Mini-Mental State Examination score of 20 to 26 inclusive at screening visit.
* Has a florbetapir PET scan consistent with the presence of amyloid pathology at screening.
Exclusion Criteria
* Ocular pathology that significantly limits ability to reliably evaluate vision or the retina.
* Use of strong inducers of cytochrome P450 3A (CYP3A).
* Sensitivity to florbetapir or ¹⁸F-AV-1451.
* Contraindication to MRI or PET or poor venous access for blood draws.
55 Years
85 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Irvine Clinical Research Center
Irvine, California, United States
Sutter Medical Group
Sacramento, California, United States
Pacific Research Network Inc
San Diego, California, United States
Sharp Mesa Vista Hospital
San Diego, California, United States
Ray Dolby Brain Health Center/Sutter Health/CPMC
San Francisco, California, United States
Syrentis Clinical Research
Santa Ana, California, United States
North Bay Neuroscience Institute
Sebastopol, California, United States
New England Institute for Clinical Research
Stamford, Connecticut, United States
Christiana Care Health Service
Wilmington, Delaware, United States
Clinical Neuroscience Solutions Inc
Jacksonville, Florida, United States
Compass Research
Melbourne, Florida, United States
Florida International Research Center
Miami, Florida, United States
New Horizon Research Center
Miami, Florida, United States
The Neurology Research Group, LLC
Miami, Florida, United States
Suncoast Clinical Research
New Port Richey, Florida, United States
Renstar Medical Research
Ocala, Florida, United States
Sensible Healthcare
Ocoee, Florida, United States
Meridien Research
Spring Hill, Florida, United States
Axiom Research
Tampa, Florida, United States
United Osteoporosis Center
Gainesville, Georgia, United States
Fort Wayne Neurological Center
Fort Wayne, Indiana, United States
Indiana University School of Medicine
Indianapolis, Indiana, United States
Cotton O'Neil Clinic
Topeka, Kansas, United States
Heartland Research Associates
Wichita, Kansas, United States
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States
Boston Center for Memory
Newton, Massachusetts, United States
Missouri Memory Center
Bolivar, Missouri, United States
Clinical Research Professionals
Chesterfield, Missouri, United States
Millenium Psychiatric Associates LLC
Creve Coeur, Missouri, United States
St Lukes Hospital
Kansas City, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Las Vegas Medical Research
Las Vegas, Nevada, United States
Memory Enhancement Center of America, Inc.
Eatontown, New Jersey, United States
Pyramid Clinical Research
Monroe, New Jersey, United States
Advanced Memory Research Institute of New Jersey
Toms River, New Jersey, United States
Bio Behavioral Health
Toms River, New Jersey, United States
Albany Medical College
Albany, New York, United States
Dent Neurological Institute
Amherst, New York, United States
Valley Medical Primary Care
Centerville, Ohio, United States
University of Cincinnati Health Neurology
Dayton, Ohio, United States
Neurology Diagnostics, Inc.
Dayton, Ohio, United States
Insight Clinical Trials
Shaker Heights, Ohio, United States
Abington Neurological Associates
Abington, Pennsylvania, United States
Lehigh Center for Clinical Research
Allentown, Pennsylvania, United States
Clinical Trial Center, LLC, Psychiatry
Jenkintown, Pennsylvania, United States
Clinical Trials of South Carolina
Charleston, South Carolina, United States
Baylor AT&T Memory Center
Dallas, Texas, United States
Nantz National Alzheimer Center
Houston, Texas, United States
University of Texas Health Services Center - Houston
Houston, Texas, United States
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.
Box Hill, , Australia
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Chermside, , Australia
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Darlinghurst, , Australia
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Erina, , Australia
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Glen Iris, , Australia
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Heidelberg, , Australia
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Herston, , Australia
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Nedlands, , Australia
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Parkville, , Australia
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West Perth, , Australia
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Gatineau, , Canada
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Ottawa, , Canada
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Verdun, , Canada
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Akashi, , Japan
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Hachiōji, , Japan
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Ikeda, , Japan
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Kasukabe-shi, , Japan
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Kyoto, , Japan
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Nagoya, , Japan
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Nerima-ku, , Japan
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Osaka, , Japan
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Osaka, , Japan
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Setagaya-ku, , Japan
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Takamatsu, , Japan
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Tokyo, , Japan
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Wako, , Japan
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.
Yokosuka-shi, , Japan
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Click here for more information about this study: A Study of LY3202626 on Disease Progression in Participants With Mild Alzheimer's Disease Dementia (NAVIGATE-AD)
Other Identifiers
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I7X-MC-LLCF
Identifier Type: OTHER
Identifier Source: secondary_id
16223
Identifier Type: -
Identifier Source: org_study_id
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