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A Study of LY3202626 on Disease Progression in Participants With Mild Alzheimer's Disease Dementia (NAVIGATE-AD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
Eli Lilly and Company

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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: LY3202626 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 316 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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

Arm Intervention/treatment
Experimental: Dose 1 LY3202626
3 mg LY3202626 given orally once daily for 52 weeks.
Drug: LY3202626
Administered orally

Experimental: Dose 2 LY3202626
12 mg LY3202626 given orally once daily for 52 weeks.
Drug: LY3202626
Administered orally

Experimental: Placebo
Placebo given orally once daily for 52 weeks.
Drug: Placebo
Administered orally

Primary Outcome Measures :
  1. Change from Baseline in Positron Emission Tomography (PET) Standard Uptake Value Ratio (SUVr) of ¹⁸F-AV-1451 [ Time Frame: Baseline, Week 52 ]

Secondary Outcome Measures :
  1. Percentage of Participants with Emergent Magnetic Resonance Imaging (MRI) Findings [ Time Frame: Week 52 ]
  2. Percentage of Participants with Amyloid-Related Imaging Abnormalities (ARIA) [ Time Frame: Week 52 ]
  3. 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 ]
  4. Pharmacokinetics (PK): Area Under the Plasma Concentration-Time Curve at Steady State of LY3202626 [ Time Frame: Baseline through Week 52 ]
  5. Change From Baseline in Plasma Amyloid Beta Aβ₁₋₄₀, ₁₋₄₂, and 1-x Concentration [ Time Frame: Baseline through Week 52 ]
  6. Change from Baseline on the 13-item Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog₁₃) [ Time Frame: Baseline, Week 52 ]
  7. Change from Baseline on the Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory (ADCS-iADL) [ Time Frame: Baseline, Week 52 ]
  8. Change from Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) [ Time Frame: Baseline, Week 52 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   55 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT02791191

Show Show 76 study locations
Sponsors and Collaborators
Eli Lilly and Company
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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

Additional Information:
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Responsible Party: Eli Lilly and Company Identifier: NCT02791191    
Other Study ID Numbers: 16223
I7X-MC-LLCF ( Other Identifier: Eli Lilly and Company )
First Posted: June 6, 2016    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
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.
Keywords provided by Eli Lilly and Company:
BACE inhibitor
Additional relevant MeSH terms:
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Alzheimer Disease
Disease Progression
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Disease Attributes
Pathologic Processes