Study Stopped
Low likelihood of identifying a statistically significant treatment effect.
A Study of LY3202626 on Disease Progression in Participants With Mild Alzheimer's Disease Dementia
NAVIGATE-AD
Effect of LY3202626 on Alzheimer's Disease Progression as Measured by Cerebral ¹⁸F-AV-1451 Tau-PET in Mild Alzheimer's Disease Dementia
2 other identifiers
interventional
316
4 countries
76
Brief Summary
The main purpose of this study is to evaluate the safety and the effect on brain tau of the study drug LY3202626 in participants with mild Alzheimer's disease (AD) dementia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2016
76 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 1, 2016
CompletedFirst Posted
Study publicly available on registry
June 6, 2016
CompletedStudy Start
First participant enrolled
June 16, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 2, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 2, 2018
CompletedResults Posted
Study results publicly available
April 19, 2021
CompletedApril 19, 2021
March 1, 2021
2 years
June 1, 2016
March 22, 2021
March 22, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in ¹⁸F-AV-1451 Positron Emission Tomography (PET) Standard Uptake Value Ratio (SUVr) at 52 Weeks
The 18F-AV-1451 PET tracer assesses change from baseline in the pharmacodynamic effect of 3 mg and 12 mg doses of LY3202626 in participants with mild Alzheimer's disease (AD), compared with placebo at Week 52.The SUVr of ¹⁸F-AV-1451 was modeled using analysis of covariance (ANCOVA) to include the fixed, categorical effects of treatment dose, and the continuous, fixed covariate of baseline Tau PET SUVr and age at baseline.
Baseline, Week 52
Secondary Outcomes (8)
Percentage of Participants With Emergent Magnetic Resonance Imaging (MRI) Findings
Week 52
Percentage of Participants With Amyloid-Related Imaging Abnormalities (ARIA)
Week 52
Percentage of Participants With Suicidal Ideation and Behaviors Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) Scores
Baseline through Week 52
Pharmacokinetics (PK): Area Under the Plasma Concentration-Time Curve at Steady State (AUC [T,SS]) of LY3202626
Week 2, 4, and 12: Predose and Postdose prior to departing; Week 8 and 16: Postdose after arriving and prior to departing; Week 24: Postdose after cognitive testing
Change From Baseline in Plasma Amyloid Beta Aβ₁-₄₀, ₁-₄₂, and 1-x Concentration
Baseline, Week 52
- +3 more secondary outcomes
Study Arms (3)
Dose 1 LY3202626
EXPERIMENTAL3 mg LY3202626 given orally once daily for 52 weeks.
Dose 2 LY3202626
EXPERIMENTAL12 mg LY3202626 given orally once daily for 52 weeks.
Placebo
EXPERIMENTALPlacebo given orally once daily for 52 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- Present with mild AD dementia based on the National Institute on Aging (NIA) and the Alzheimer's Association (AA) disease diagnostic criteria as determined by a qualified clinician approved by the Sponsor or designee.
- 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.
You may not qualify if:
- Significant neurological disease affecting the central nervous system (CNS), 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, multiple concussions, or epilepsy or recurrent seizures (except febrile childhood seizures).
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (76)
Irvine Clinical Research Center
Irvine, California, 92614, United States
Sutter Medical Group
Sacramento, California, 95816, United States
Pacific Research Network Inc
San Diego, California, 92103, United States
Sharp Mesa Vista Hospital
San Diego, California, 92123, United States
Ray Dolby Brain Health Center/Sutter Health/CPMC
San Francisco, California, 94114, United States
Syrentis Clinical Research
Santa Ana, California, 92705, United States
North Bay Neuroscience Institute
Sebastopol, California, 95472, United States
New England Institute for Clinical Research
Stamford, Connecticut, 06905, United States
Christiana Care Health Service
Wilmington, Delaware, 19801, United States
Clinical Neuroscience Solutions Inc
Jacksonville, Florida, 32256, United States
Compass Research
Melbourne, Florida, 32940, United States
Florida International Research Center
Miami, Florida, 33173, United States
New Horizon Research Center
Miami, Florida, 33175, United States
The Neurology Research Group, LLC
Miami, Florida, 33176, United States
Suncoast Clinical Research
New Port Richey, Florida, 34652, United States
Renstar Medical Research
Ocala, Florida, 34470, United States
Sensible Healthcare
Ocoee, Florida, 34761, United States
Meridien Research
Spring Hill, Florida, 34609, United States
Axiom Research
Tampa, Florida, 33609, United States
United Osteoporosis Center
Gainesville, Georgia, 30501, United States
Fort Wayne Neurological Center
Fort Wayne, Indiana, 46804, United States
Indiana University School of Medicine
Indianapolis, Indiana, 46202, United States
Cotton O'Neil Clinic
Topeka, Kansas, 66606, United States
Heartland Research Associates
Wichita, Kansas, 67205, United States
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21224, United States
Boston Center for Memory
Newton, Massachusetts, 02459, United States
Missouri Memory Center
Bolivar, Missouri, 65613, United States
Clinical Research Professionals
Chesterfield, Missouri, 63005, United States
Millenium Psychiatric Associates LLC
Creve Coeur, Missouri, 63141, United States
St Lukes Hospital
Kansas City, Missouri, 64111, United States
Washington University School of Medicine
St Louis, Missouri, 63108, United States
Las Vegas Medical Research
Las Vegas, Nevada, 89113, United States
Memory Enhancement Center of America, Inc.
Eatontown, New Jersey, 07724, United States
Pyramid Clinical Research
Monroe, New Jersey, 08831, United States
Advanced Memory Research Institute of New Jersey
Toms River, New Jersey, 08755, United States
Bio Behavioral Health
Toms River, New Jersey, 08755, United States
Albany Medical College
Albany, New York, 12206, United States
Dent Neurological Institute
Amherst, New York, 14226, United States
Valley Medical Primary Care
Centerville, Ohio, 45459, United States
University of Cincinnati Health Neurology
Dayton, Ohio, 45417, United States
Neurology Diagnostics, Inc.
Dayton, Ohio, 45459, United States
Insight Clinical Trials
Shaker Heights, Ohio, 44122, United States
Abington Neurological Associates
Abington, Pennsylvania, 19090, United States
Lehigh Center for Clinical Research
Allentown, Pennsylvania, 18104, United States
Clinical Trial Center, LLC, Psychiatry
Jenkintown, Pennsylvania, 19046, United States
Clinical Trials of South Carolina
Charleston, South Carolina, 29406, United States
Baylor AT&T Memory Center
Dallas, Texas, 75231, United States
Nantz National Alzheimer Center
Houston, Texas, 77030, United States
University of Texas Health Services Center - Houston
Houston, Texas, 77054, 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, 3128, Australia
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Chermside, 4032, Australia
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Darlinghurst, 2010, Australia
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Erina, 2250, Australia
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Glen Iris, 3146, Australia
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Heidelberg, 3084, Australia
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Herston, 4029, Australia
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Nedlands, 6009, Australia
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Parkville, 3050, Australia
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West Perth, 6005, Australia
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Gatineau, J8T 8J1, Canada
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Ottawa, KIN 5C8, Canada
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Verdun, H4H 1R3, Canada
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Akashi, 673-0891, Japan
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Hachiōji, 193-0998, Japan
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Ikeda, 563-0058, Japan
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Kasukabe-shi, 344-0036, Japan
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Kyoto, 606-0851, Japan
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Nagoya, 451-8511, Japan
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Nerima-ku, 179-0072, Japan
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Osaka, 533-0004, Japan
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Osaka, 559-0004, Japan
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Setagaya-ku, 158-8531, Japan
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Takamatsu, 760-8557, Japan
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Tokyo, 156-0041, 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.
Wako, 351-0111, Japan
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Yokosuka-shi, 238-0042, Japan
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Study was terminated due to low likelihood of identifying a statistically significant treatment effect.
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 1, 2016
First Posted
June 6, 2016
Study Start
June 16, 2016
Primary Completion
July 2, 2018
Study Completion
July 2, 2018
Last Updated
April 19, 2021
Results First Posted
April 19, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.