A Study of LY3002813 in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ)

Lilly

Status and phase: Completed; Phase 2

Conditions: Alzheimer Disease

Treatments: Drug: Donanemab; Drug: LY3202626; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03367403

16933

I5T-MC-AACG (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to evaluate the safety, tolerability and efficacy of LY3002813 in early symptomatic Alzheimer's disease.

Enrollment: 272 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 20 to 28 (inclusive) at baseline or an acceptable historical flortaucipir PET scan within 6 months prior to baseline that meets the central read criteria.
• Meet 18F flortaucipir PET scan eligibility criteria.
• Meet 18F florbetapir PET scan (central read) eligibility criteria.

Exclusion criteria

• Have a history of long QT syndrome.
• Have received treatment with a stable dose of an acetylcholinesterase inhibitor (AChEI) and/or memantine for less than 2 months before randomization.
• Contraindication to MRI.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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272 participants in 3 patient groups, including a placebo group

Donanemab Monotherapy (Donanemab-M)

Experimental group

Description:

Participants received 700 milligram (mg) donanemab intravenously (IV) every 4 weeks (Q4W) x 3 doses, then 1400 mg donanemab IV Q4W for up to 72 weeks.

Treatment:

Drug: Donanemab

Placebo

Placebo Comparator group

Description:

Participants received placebo IV Q4W for up to 72 weeks.

Treatment:

Drug: Placebo

Donanemab in Combination With LY3202626 (Donanemab-C)

Experimental group

Description:

Participants received 700 mg donanemab IV Q4W x 3 doses, then 1400 mg donanemab IV Q4W in combination with 12 mg of LY3202626 orally for up to 72 weeks. As per protocol amendment (d) approved on Oct 9, 2018, donanemab in combination with LY3202626 (donanemab-C) arm discontinued as there was a low probability of identifying a statistically significant effect of 12mg of LY3202626 slowing cognitive decline.

Treatment:

Drug: LY3202626

Drug: Donanemab