Donanemab for Early Alzheimer's Disease

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Eli Lilly and Company

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial is testing different doses of donanemab, a drug aimed at helping people with early Alzheimer's disease. Donanemab has shown rapid reduction of brain amyloid in early Alzheimer's disease. The study will look at how often and how severely participants experience a side effect involving brain swelling. Researchers also want to find out which patient characteristics might predict this side effect.

Eligibility Criteria

This trial is for adults with early symptomatic Alzheimer's who have had memory issues for over 6 months, confirmed amyloid pathology in the brain, and a certain score on a mental state exam. People with serious illnesses, cancer within the last 5 years, life expectancy under 2 years, or significant neurological diseases other than Alzheimer's can't join.

Treatment Details

The study tests different doses of Donanemab to see how they affect brain swelling (ARIA-E) in people with early Alzheimer's. It also looks at whether certain characteristics predict ARIA risk. Participants will either receive Donanemab or a placebo.

4Treatment groups

Experimental Treatment

Group I: Donanemab Dose Level 4Experimental Treatment2 Interventions

Participants will receive donanemab by IV infusion. Participants will receive placebo at certain intervals to preserve the blind.

Group II: Donanemab Dose Level 3Experimental Treatment2 Interventions

Participants will receive donanemab by IV infusion. Participants will receive placebo at certain intervals to preserve the blind.

Group III: Donanemab Dose Level 2Experimental Treatment2 Interventions

Participants will receive donanemab by IV infusion. Participants will receive placebo at certain intervals to preserve the blind.

Group IV: Donanemab Dose Level 1Experimental Treatment2 Interventions

Participants will receive donanemab by intravenously (IV) infusion. Participants will receive placebo at certain intervals to preserve the blind.