Donanemab for Alzheimer's Disease

Not yet recruiting at 52 trial locations

Overseen By Physicians interested in becoming principal investigators please contact

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Eli Lilly and Company

Disqualifiers: Serious illnesses, MRI contraindications, 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: 6

Duration: 2.5 years

What You Need to Know Before You Apply

What is the purpose of this trial?

The main purpose of this study is to determine if participants who previously took donanemab get clinical benefit when they receive annual doses. For each participant, the study will last up to 2.5 years and will include 6 visits.

Who Is on the Research Team?

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

This trial is for people who finished the previous AACM (TRAILBLAZER-ALZ 3-EXT) study, have a reliable partner to help report on their daily function and memory, and are not able to become pregnant or agree to use contraception if required.

Inclusion Criteria

* Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

* 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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive annual doses of Donanemab or placebo administered intravenously

2.5 years

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Donanemab

Trial Overview

The study tests whether annual doses of donanemab provide ongoing benefits compared to placebo in people with Alzheimer's disease. Participants are randomly assigned to receive either donanemab or a placebo over about 2.5 years.

How Is the Trial Designed?

Group I: Donanemab Experimental Treatment 1 Intervention

Donanemab administered intravenously (IV)

Group II: Placebo Placebo Group 1 Intervention

Placebo IV

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