Donanemab follow-up dosing in participants who previously completed TRAILBLAZER-ALZ 3-EXT

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 interventional trial evaluates annual donanemab or placebo in participants who completed AACM Addendum 7. Participants will be followed for up to 2.5 years with six visits to assess clinical outcomes and safety. The study uses a randomized design to compare donanemab to placebo and includes regular imaging and clinical assessments. Eligibility requires prior completion of AACM Addendum 7, a reliable study partner, and sex assigned at birth criteria, with MRI safety requirements and standard contraception considerations. Key exclusion criteria include unstable illnesses and contraindications to MRI or intracranial abnormalities. Lead sponsor is Eli Lilly, with participating sites in Arizona and California.

Why it matters

Who can join: the full rules

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.

Where it's running

• Banner Alzheimer's Institute
  Phoenix, Arizona, United States Recruiting
• Care Access - Huntington Beach
  Huntington Beach, California, United States Recruiting
• Irvine Clinical Research
  Irvine, California, United States Recruiting
• Healthy Brain Clinic
  Long Beach, California, United States Recruiting
• Artemis Institute for Clinical Research
  Riverside, California, United States Recruiting
• Headlands Research- Sacramento
  Sacramento, California, United States Recruiting

+12 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
• Email: LillyTrials@Lilly.com
• Phone: 1-317-615-4559

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.