Donanemab for Alzheimer's Disease

Not currently recruiting at 338 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of donanemab, a new treatment for early Alzheimer's Disease. Participants receive either the drug or a placebo through an IV. The study aims to determine if donanemab can manage Alzheimer's symptoms before they fully develop. Individuals with early signs of Alzheimer's who are still fully functioning might be suitable candidates. Participants need a study partner familiar with their daily activities and behaviors. As a Phase 3 trial, this study is the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but it excludes those who have used prescription medications for mild cognitive impairment or Alzheimer's Disease. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that donanemab is likely to be safe for humans?

Research has shown that donanemab has been tested in people with Alzheimer's disease. In these studies, the treatment reduced amyloid plaques, proteins that accumulate in the brain and are linked to Alzheimer's.

Participants generally tolerated the treatment well. Some experienced side effects, but these were mostly mild, with serious side effects being less common.

As this trial is in a later phase, more safety information is available compared to earlier stages. This indicates that donanemab has already demonstrated some level of safety in previous studies. Always consult a healthcare professional with any questions or concerns about joining a trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Alzheimer's?

Researchers are excited about donanemab for Alzheimer's disease because it targets amyloid plaques in the brain, a hallmark of Alzheimer's, using a unique mechanism. Unlike standard treatments such as cholinesterase inhibitors and memantine, which mainly manage symptoms, donanemab works by directly binding to and clearing amyloid plaques. This innovative approach could potentially slow disease progression rather than just addressing symptoms, offering hope for more meaningful improvements in patient outcomes.

What evidence suggests that donanemab might be an effective treatment for Alzheimer's?

Research has shown that donanemab, which participants in this trial may receive, may help treat Alzheimer's disease. Studies have found that donanemab can improve memory and thinking skills in people with early Alzheimer's. In one study, 52% of patients with low to medium levels of a protein called tau had positive results after one year of treatment. Another study demonstrated that donanemab slowed the decline in thinking skills compared to a placebo, which is also being used in this trial as a comparator. This treatment targets amyloid plaques, thought to play a role in Alzheimer's disease. These findings suggest donanemab could be effective for Alzheimer's, but more research is needed. ^{3 6 7 8 9}

Who Is on the 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

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2807533

Trial of Donanemab in Early Symptomatic Alzheimer Disease These clinical outcomes were achieved in 52% of low/medium tau participants completing donanemab treatment by 1 year, based on when a ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12040886/

Re-evaluation of the efficacy and safety of anti-Aβ monoclonal ... Lecanemab/Donanemab can improve memory, cognitive function, and daily living abilities in patients with early AD, significantly reduce the composite score of ...

3. alz-journals.onlinelibrary.wiley.com alz-journals.onlinelibrary.wiley.com/doi/10.1002/alz.13700

How donanemab data address the coverage with evidence ... Results of TRAILBLAZER-ALZ 2 demonstrated the positive impact of donanemab in amyloid-positive early symptomatic Alzheimer's disease regardless ...

4. dig.pharmacy.uic.edu dig.pharmacy.uic.edu/faqs/2024-2/sep-2024-faqs/what-evidence-supports-the-efficacy-and-safety-of-donanemab-for-alzheimer-disease/

What evidence supports the efficacy and safety of donanemab ... Change from baseline in the iADRS score at 76 weeks was -6.02 in the donanemab group and -9.27 in the placebo group (difference, 3.25; 95% CI, 1.88 to 4.62; p< ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04437511

NCT04437511 | A Study of Donanemab (LY3002813) in ... The reason for this study is to see how safe and effective the study drug donanemab is in participants with early Alzheimer's disease.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9818878/

Donanemab for Alzheimer's Disease: A Systematic Review of ... The primary outcome was the Donanemab-induced amyloid reduction, specifically the association between amyloid plaque clearance after 24 weeks ...

7. jamanetwork.com jamanetwork.com/journals/jamaneurology/fullarticle/2839837

Posttreatment Amyloid Levels and Clinical Outcomes ... Donanemab slowed clinical progression by 22.3% and 28.9% relative to placebo as assessed by integrated AD Rating Scale (iADRS) and Clinical ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2274580725000949

Donanemab: Appropriate use recommendations Treatment with donanemab was associated with 32 % slowing of decline on the primary clinical endpoint, the Integrated Alzheimer's Disease Rating Scale (iADRS). ...

9. nejm.org nejm.org/doi/full/10.1056/NEJMoa2100708

Donanemab in Early Alzheimer's Disease In patients with early Alzheimer's disease, donanemab resulted in a better composite score for cognition and for the ability to perform ...