A Study of LY3202626 on Disease Progression in Participants With Mild Alzheimer's Disease Dementia (NAVIGATE-AD)
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|ClinicalTrials.gov Identifier: NCT02791191|
Recruitment Status : Terminated (Low likelihood of identifying a statistically significant treatment effect.)
First Posted : June 6, 2016
Last Update Posted : October 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer's Disease||Drug: LY3202626 Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||316 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Effect of LY3202626 on Alzheimer's Disease Progression as Measured by Cerebral ¹⁸F-AV-1451 Tau-PET in Mild Alzheimer's Disease Dementia|
|Actual Study Start Date :||June 16, 2016|
|Actual Primary Completion Date :||July 2, 2018|
|Actual Study Completion Date :||July 2, 2018|
Experimental: Dose 1 LY3202626
3 mg LY3202626 given orally once daily for 52 weeks.
Experimental: Dose 2 LY3202626
12 mg LY3202626 given orally once daily for 52 weeks.
Placebo given orally once daily for 52 weeks.
- Change from Baseline in Positron Emission Tomography (PET) Standard Uptake Value Ratio (SUVr) of ¹⁸F-AV-1451 [ Time Frame: Baseline, Week 52 ]
- Percentage of Participants with Emergent Magnetic Resonance Imaging (MRI) Findings [ Time Frame: Week 52 ]
- Percentage of Participants with Amyloid-Related Imaging Abnormalities (ARIA) [ Time Frame: Week 52 ]
- Percentage of Participants with Suicidal Ideation and Behaviors Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) Scores [ Time Frame: Baseline through Week 52 ]
- Pharmacokinetics (PK): Area Under the Plasma Concentration-Time Curve at Steady State of LY3202626 [ Time Frame: Baseline through Week 52 ]
- Change From Baseline in Plasma Amyloid Beta Aβ₁₋₄₀, ₁₋₄₂, and 1-x Concentration [ Time Frame: Baseline through Week 52 ]
- Change from Baseline on the 13-item Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog₁₃) [ Time Frame: Baseline, Week 52 ]
- Change from Baseline on the Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory (ADCS-iADL) [ Time Frame: Baseline, Week 52 ]
- Change from Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) [ Time Frame: Baseline, Week 52 ]
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): NCT02791191
|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|