Donanemab for Early-Stage Alzheimer's Disease

What Is This Study About?

This Phase 2 clinical trial (TRAILBLAZER-ALZ 2) will test whether donanemab, also known as LY3002813, is safe and effective to slow cognitive impairment and reduce amyloid plaque in people with symptoms of early-stage Alzheimer's disease. Participants will be randomly assigned to receive injections of donanemab or a placebo. The study will last about 133 weeks and may include up to 26 visits. The researchers will measure cognition as well as changes in the brain, such as amyloid plaque build-up, using MRI and positron emission tomography (PET) brain imaging scans.

Do I Qualify To Participate in This Study?

Must have:

• Gradual and progressive changes in memory function for at least six months
• Mini-Mental State Examination Score of 20 to 28
• Presence of amyloid plaque and abnormal tau protein in the brain, based on a PET brain scan
• Have a study partner who can provide written informed consent for participant

Must NOT have:

• Have conditions that prevent the safe use of MRI or PET scan, such as claustrophobia, pacemakers or other metal devices, allergy to the imaging drug, or a body weight over the instrument limits
• Receiving antibody therapy (immunoglobulin G)

If I Qualify, Who Do I Contact?

Contact study personnel listed either under the general study contact or the location nearest you.

 

Who Is the General Study Contact?

For more information, visit the study website: TRAILBLAZER-ALZ 2.

Where Is This Study Located?

Who Sponsors This Study?

Lead: Eli Lilly and Company

Source: ClinicalTrials.gov ID: NCT04437511