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NCT Number: NCT07602582

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

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.

Recruiting

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Plaque, Amyloid Tauopathies

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Tokyo-Eki Center-building Clinic, Chūōku, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Have completed study AACM Addendum 7.
  • Have a reliable study partner and backup study partner familiar with overall function and behavior, such as day-to-day activities and cognitive abilities.
  • Are individuals assigned female at birth who are not of childbearing potential, or are individuals assigned male at birth.
  • Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Exclusion criteria

  • Current serious or unstable illnesses that, in the investigator's opinion, could interfere with participation in this study.
  • Have any contraindications for magnetic resonance imaging (MRI), including claustrophobia or the presence of contraindicated metal (ferromagnetic) implants/cardiac pacemaker.
  • Have any intracranial abnormality or lesion, including but not limited to macrohemorrhage, inflammation, or structural findings that, in the opinion of the investigator, may pose an unacceptable safety risk to the participant. Screening MRI finding of amyloid-related imaging abnormalities with edema (ARIA-E) may be monitored for resolution.
  • Contraindication to florbetapir F 18 PET.
  • Have had history of amyloid-targeting therapy treatment outside donanemab trials.
  • Have participated, within the last 30 days, in a clinical trial involving a study intervention judged not to be scientifically or medically compatible with this study.

Treatment and study plan

Donanemab

Drug

Administered IV

Placebo

Drug

Administered IV

Primary outcomes

  1. Change from Baseline as Measured by Clinical Dementia Rating - Sum of Boxes (CDR-SB)

    Time frame: Baseline through Week 130

Secondary outcomes

  1. Change from Baseline as Measured by Cognitive Function Index (CFI)

    Time frame: Baseline through Week 130

  2. Change from Baseline in Brain Amyloid Plaque Levels as Measured by Florbetapir F 18 Positron Emission Tomography (PET) Scan.

    Time frame: Baseline through Week 130

  3. Change From Baseline in Plasma Phosphorylated Tau at Threonine 217 (P-tau217)

    Time frame: Baseline through Week 130

  4. Pharmacokinetics (PK): Peak Concentrations of Serum Donanemab

    Time frame: Baseline, Week 52, Week 104

Study contacts

Contact information is provided by the study sponsor or research team.

Physicians interested in becoming principal investigators please contact

CONTACT

[email protected]

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

[email protected]

1-317-615-4559

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

An Annual Dosing Study of Donanemab in Participants Who Completed Donanemab Study AACM

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
May 22, 2026
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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