Donanemab for Alzheimer's Disease

Recruiting at 267 trial locations

Overseen By Awawu Igbinadolor

Age: 65+

Sex: Any

Trial Phase: Phase 3

Sponsor: Eli Lilly and Company

Must not be taking: Cognitive enhancers

Disqualifiers: Mild cognitive impairment, Dementia, Cancer, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 182 weeks

2996 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing donanemab, a medication aimed at helping people with Alzheimer's Disease by removing harmful protein clumps from their brains. Donanemab has shown promise in reducing these harmful proteins in Alzheimer's disease.

Research Team

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Eligibility Criteria

This trial is for people aged 65-80 who are at risk of Alzheimer's but don't yet have it. Participants must be able to get an MRI and do cognitive tests, not be in another study, and have a family history of Alzheimer's or early signs of amyloid and tau pathology.

Inclusion Criteria

I am willing to do cognitive tests during screening.

I do not have Alzheimer's or dementia.

I am between 65 and 80 years old.

Exclusion Criteria

Has a reliable study partner and backup study partner familiar with overall function and behavior, such as day-to-day activities and cognitive abilities.

My tests show early signs of Alzheimer's disease.

A telephone interview for cognitive status - modified (TICS-M) score reflective of intact cognitive functioning.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive donanemab or placebo intravenously to evaluate safety and efficacy

182 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Addendum

Additional 800 participants enrolled to assess safety of a different titration regimen

12 months

Treatment Details

Interventions

• Donanemab

Trial Overview The trial is testing Donanemab against a placebo to see if it can prevent the onset of Alzheimer's Disease in individuals who show early signs but do not yet have symptoms. The safety and effectiveness will be evaluated.

Participant Groups

Group I: Donanemab Experimental Treatment 1 Intervention

Donanemab administered intravenously (IV)

Group II: Placebo Placebo Group 1 Intervention

Placebo is administered intravenously

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University