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

Lilly

Status and phase: Terminated; Phase 2

Conditions: Alzheimer's Disease

Treatments: Drug: LY3202626; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02791191

16223

I7X-MC-LLCF (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 316 patients

Sex: All

Ages: 55 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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316 participants in 3 patient groups

Dose 1 LY3202626

Experimental group

Description:

3 mg LY3202626 given orally once daily for 52 weeks.

Treatment:

Drug: LY3202626

Dose 2 LY3202626

Experimental group

Description:

12 mg LY3202626 given orally once daily for 52 weeks.

Treatment:

Drug: LY3202626

Placebo

Experimental group

Description:

Placebo given orally once daily for 52 weeks.

Treatment:

Drug: Placebo