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

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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

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

Trial contacts and locations

69

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Data sourced from clinicaltrials.gov

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