A Study of Donanemab (LY3002813) in Participants Who Completed Study AACM (TRAILBLAZER-ALZ 3-EXT).

Conditions

• Alzheimer Disease
• Dementia
• Plaque, Amyloid

Eligibility Criteria

Sex

ALL

Age

55 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Donanemab — DRUG
  Administered IV
• Placebo — DRUG
  Administered IV

Study Details

The main purpose of this study is to determine if participants who previously took donanemab get clinical benefit when they receive annual doses. For each participant, the study will last up to 2.5 years and will include 6 visits.

Key Dates

First listed

May 22, 2026

Start date

May 22, 2026

Status verified

Jul 2026

Primary completion

Sep 30, 2029

Completion

Sep 30, 2029

Study Design

Enrollment

550 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Donanemab
  Donanemab administered intravenously (IV)
• Placebo Comparator: Placebo
  Placebo IV

Primary Outcome Measure

Change from Baseline as Measured by Clinical Dementia Rating - Sum of Boxes (CDR-SB) [ Time Frame: Baseline through Week 130 ]

Central Contacts

• Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  1-317-615-4559
  [email protected]
• Physicians interested in becoming principal investigators please contact
  [email protected]

Locations (52)

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