A Study of LY3202626 on Disease Progression in Participants With Mild Alzheimer's Disease Dementia (NAVIGATE-AD)
- Conditions
- Alzheimer's Disease
- Registration Number
- JPRN-jRCT2080223321
- Lead Sponsor
- Eli Lilly Japan K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- recruiting
- Sex
- All
- Target Recruitment
- Not specified
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.
-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) within 30 days before baseline.
-Sensitivity to florbetapir or 18F-AV-1451.
-Contraindication to MRI or PET or poor venous access for blood draws.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method