A Study of LY3372689 to Assess the Safety, Tolerability, and Efficacy in Participants With Alzheimer's Disease

Lilly

Status and phase: Active, not recruiting; Phase 2

Conditions: Alzheimer Disease

Treatments: Drug: LY3372689; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05063539

I9X-MC-MTAE (Other Identifier)

2021-000170-29 (EudraCT Number)

18094

Details and patient eligibility

About

The purpose of this study is to assess the safety, tolerability and effect of study drug LY3372689 in participants with early symptomatic Alzheimer's Disease

Enrollment: 330 estimated patients

Sex: All

Ages: 60 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Gradual and progressive change in memory function reported by participants or informants for ≥ 6 months
• MMSE score of 22 to 30 (inclusive) at baseline
• CDR global score of 0.5 to 1.0 (inclusive), with a memory box score ≥0.5.
• Meet 18F flortaucipir positron emission tomography (PET) scan (central analysis) criteria
• Have a study partner who will provide written informed consent to participate

Exclusion criteria

• Contraindication to MRI or PET scans
• Have known allergies to LY3372689, related compounds, or any components of the formulations

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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330 participants in 3 patient groups, including a placebo group

LY3372689 High Dose

Experimental group

Description:

LY3372689 given orally

Treatment:

Drug: LY3372689

Drug: LY3372689

LY3372689 Low Dose

Experimental group

Description:

LY3372689 given orally

Treatment:

Drug: LY3372689

Drug: LY3372689

Placebo

Placebo Comparator group

Description:

Placebo given orally

Treatment:

Drug: Placebo