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Trial record 2 of 5 for:    LY3202626

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 : Active, not recruiting
First Posted : June 6, 2016
Last Update Posted : May 21, 2018
Sponsor:
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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 380 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
Study Start Date : June 2016
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018


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

Experimental: Dose 2 LY3202626
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

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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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT02791191


  Show 76 Study Locations
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

Additional Information:
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02791191     History of Changes
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: May 21, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.

Keywords provided by Eli Lilly and Company:
BACE inhibitor

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Disease Progression
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Disease Attributes
Pathologic Processes