NCT05026866

A Study of Donanemab Versus Placebo in Participants at Risk for Cognitive and Functional Decline of Alzheimer's Disease

Active, enrolled Phase 3 Last updated 19 January 2026

What this trial tests

Phase 3 trial testing Donanemab in Alzheimer Disease in 2,996 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

27 August 2021

Primary endpoint
1 November 2027

1 November 2027

Quick facts

Lead sponsor	Eli Lilly and Company
Phase	Phase 3
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	2,996
Start date	27 August 2021
Primary completion	1 November 2027
Estimated completion	1 November 2027
Sites	216 locations across United States, Japan, Puerto Rico

Drugs / interventions tested

• Donanemab (DONANEMAB) — full drug profile →
• Placebo

Conditions studied

• Alzheimer Disease — all drugs for Alzheimer Disease →

Sponsor

Eli Lilly and Company — full company profile →

Who can join

Adults 55 to 80, any sex, with Alzheimer Disease. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Time to Clinical Progression of Composite Endpoint as Measured by Clinical Dementia Rating (CDR) in the Primary Study Population (Baseline CDR-Global Score [GS 0])
  Time frame: Estimated up to Week 332
  Time to clinical progression as measured by CDR. CDR is a clinician-rated scale that provides an overall assessment of the participant's stage on the spectrum of Alzheimer's Disease (AD) dementia

Sponsor's own description

The main purpose of this study is to evaluate the safety and efficacy of donanemab in participants with preclinical Alzheimer's Disease (AD) over up to 332 weeks. Approximately 800 additional participants will be enrolled in the 12-month Addendum 7 to assess safety of a different titration regimen.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Amyloid β-based therapy for Alzheimer's disease: challenges, successes and future.
   Zhang Y, Chen H, Li R, Sterling K, et al · · 2023 · cited 579× · PMID 37386015 · DOI 10.1038/s41392-023-01484-7
2. The Alzheimer's Association appropriate use recommendations for blood biomarkers in Alzheimer's disease.
   Hansson O, Edelmayer RM, Boxer AL, Carrillo MC, et al · · 2022 · cited 479× · PMID 35908251 · DOI 10.1002/alz.12756
3. Alzheimer's disease drug development pipeline: 2022.
   Cummings J, Lee G, Nahed P, Kambar MEZN, et al · · 2022 · cited 369× · PMID 35516416 · DOI 10.1002/trc2.12295
4. Blood biomarkers for Alzheimer's disease in clinical practice and trials.
   Hansson O, Blennow K, Zetterberg H, Dage J. · · 2023 · cited 362× · PMID 37202517 · DOI 10.1038/s43587-023-00403-3
5. Alzheimer's disease drug development pipeline: 2023.
   Cummings J, Zhou Y, Lee G, Zhong K, et al · · 2023 · cited 326× · PMID 37251912 · DOI 10.1002/trc2.12385
6. Antibodies to watch in 2022.
   Kaplon H, Chenoweth A, Crescioli S, Reichert JM. · · 2022 · cited 245× · PMID 35030985 · DOI 10.1080/19420862.2021.2014296
7. Anti-Amyloid Monoclonal Antibodies for the Treatment of Alzheimer's Disease.
   Cummings J, Osse AML, Cammann D, Powell J, et al · · 2024 · cited 228× · PMID 37955845 · DOI 10.1007/s40259-023-00633-2
8. Prediction of Longitudinal Cognitive Decline in Preclinical Alzheimer Disease Using Plasma Biomarkers.
   Mattsson-Carlgren N, Salvadó G, Ashton NJ, Tideman P, et al · · 2023 · cited 225× · PMID 36745413 · DOI 10.1001/jamaneurol.2022.5272