A Study of Donanemab (LY3002813) in Participants With Early Alzheimer's Disease (TRAILBLAZER-ALZ 2)

Lilly

Status and phase: Active, not recruiting; Phase 3

Conditions: Alzheimer Disease

Treatments: Drug: Donanemab; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04437511

17737

2020-000077-25 (EudraCT Number)

I5T-MC-AACI (Other Identifier)

Details and patient eligibility

About

The reason for this study is to see how safe and effective the study drug donanemab is in participants with early Alzheimer's disease.

Additional participants will be enrolled to an addendum safety cohort. The participants will be administered open-label donanemab.

Full description

TRAILBLAZER-ALZ 2 is a Phase 3, double-blind, placebo-controlled study to evaluate the safety and efficacy of N3pG antibody (donanemab) in participants with early symptomatic AD (prodromal AD and mild dementia due to AD) with the presence of brain amyloid and tau pathology.

Following the double-blind 76-week main study period, a double-blind 78-week long-term extension period is added to further evaluate donanemab efficacy and safety over time. Participants from the addendum safety cohort are not eligible for the extension period.

Enrollment: 1,736 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
• Meet 18F flortaucipir PET scan (central read) criteria - does not apply to safety cohort
• Meet 18F florbetapir PET scan (central read) criteria
• Have a study partner who will provide written informed consent to participate

Exclusion criteria

• Contraindication to MRI or PET scans
• Current treatment with immunoglobulin G (IgG) therapy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,736 participants in 2 patient groups, including a placebo group

Donanemab

Experimental group

Description:

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

Treatment:

Drug: Donanemab

Placebo

Placebo Comparator group

Description:

Participants received placebo given IV.

Treatment:

Drug: Placebo