Phase 3 Recruiting NCT05823584

Donanemab long-term cognitive outcomes study

Eli Lilly and Company · Interventional, Randomized 1:1 · n=1,200

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Medicine Neuroscience Alzheimer's Disease

Overview

Donanemab is a monoclonal antibody targeting amyloid-β plaques in the brain — a hallmark of Alzheimer's pathology. This Phase 3 study evaluates long-term cognitive trajectory in participants with early symptomatic Alzheimer's disease who received donanemab in prior trials, with follow-up extending five years post-treatment to assess durability of effect.

Full record on ClinicalTrials.gov (NCT ID NCT05823584).

Eligibility

Inclusion criteria

- Age 60–85 years at screening - Diagnosis of early symptomatic Alzheimer's disease (MMSE 22–30 inclusive) - Prior participation in TRAILBLAZER-ALZ 2 or TRAILBLAZER-ALZ 3 study - Adequate caregiver support for study visits

Exclusion criteria

- History of significant brain hemorrhage or stroke - Current treatment with another anti-amyloid therapy - Severe renal or hepatic impairment - Active malignancy (excluding non-melanoma skin cancer)

Age range: 60–85 · Sex: All · Healthy volunteers: Requires diagnosis

Study design

Phase: Phase 3
Study type: Interventional
Allocation: Randomized 1:1
Masking: Quadruple-blind
Intervention model: Parallel assignment
Primary purpose: Treatment
Enrollment target: 1,200 participants
Started: September 2024
Estimated completion: March 2029

Outcome measures

Primary endpoint

Change from baseline in Clinical Dementia Rating–Sum of Boxes (CDR-SB) at week 130

Secondary endpoints

- Change in Alzheimer's Disease Assessment Scale–Cognitive Subscale (ADAS-Cog13) - Change in ADCS-iADL - Time to clinically meaningful disease progression

Locations & contacts

Showing 6 of 6 sites

6 sites currently enrolling. Representative sites shown below; full site list on ClinicalTrials.gov.

Mayo Clinic — Rochester, MN

Principal Investigator: David S. Knopman, MD · Status: Recruiting

Massachusetts General Hospital — Boston, MA

Principal Investigator: Reisa A. Sperling, MD · Status: Recruiting

Cleveland Clinic Lou Ruvo Center — Las Vegas, NV

Principal Investigator: Marwan N. Sabbagh, MD · Status: Recruiting

UPenn Penn Memory Center — Philadelphia, PA

Principal Investigator: Jason H. Karlawish, MD · Status: Recruiting

UCSF Memory and Aging Center — San Francisco, CA

Principal Investigator: Bruce L. Miller, MD · Status: Recruiting

Banner Alzheimer's Institute — Phoenix, AZ

Principal Investigator: Pierre N. Tariot, MD · Status: Recruiting

Sources

REG

ClinicalTrials.gov — NCT05823584

Trial registry · primary record