Donanemab for Early Alzheimer's Disease

Recruiting in Palo Alto (17 mi)

+66 other locations

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.

Inclusion Criteria

My memory has been getting worse for 6 months or more.

A mini mental state examination (MMSE) score of 20 to 28 (inclusive) at screening

Have an amyloid PET scan result from central read, consistent with the presence of amyloid pathology

Exclusion Criteria

I have had cancer or a tumor in the last 5 years.

I have had skin, cervical, or prostate cancer but they were early stage and low risk.

Has current serious or unstable illnesses including cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic (other than AD), psychiatric, immunologic, or hematologic disease and other conditions that, in the investigator's opinion, could interfere with the analyses in this study

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Participant Groups

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.