Donanemab for Cognitive Impairment
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether donanemab can slow the decline of cognitive and daily task abilities in individuals with dementia with Lewy bodies, a condition affecting memory and behavior. Participants will receive either donanemab or a placebo via IV infusion over one and a half years. Those experiencing a gradual decline in memory and daily functioning for over six months, along with specific brain test results, might qualify for this trial. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
Is there any evidence suggesting that donanemab is likely to be safe for humans?
Previous studies have shown that donanemab is generally safe for people with early Alzheimer's disease, though some side effects have been noted. The most common are changes seen in brain scans, known as Amyloid-Related Imaging Abnormalities (ARIA), which occurred in about 26.1% to 30.5% of patients. These changes do not always cause symptoms but can sometimes lead to headaches or confusion.
Donanemab has received FDA approval for treating early Alzheimer's, indicating that its safety has been carefully reviewed. This approval suggests that the benefits of donanemab in slowing memory and thinking problems outweigh the risks for many patients. Discussing potential risks and benefits with a healthcare provider is always advisable.12345Why do researchers think this study treatment might be promising?
Unlike the standard treatments for cognitive impairment, which often include medications like cholinesterase inhibitors and memantine, Donanemab works by targeting amyloid plaques in the brain. This is a new mechanism of action compared to current options, which mainly focus on neurotransmitter systems. Researchers are excited about Donanemab because it could potentially modify the disease process rather than just managing symptoms, offering hope for more effective long-term outcomes. Additionally, it is administered through an intravenous infusion, which could ensure consistent delivery and effectiveness.
What evidence suggests that donanemab might be an effective treatment for cognitive impairment?
Research has shown that donanemab, which participants in this trial may receive, can slow the worsening of Alzheimer's disease symptoms. One study found it slowed the decline in patients' conditions by 35% compared to those who took a placebo. Participants taking donanemab experienced 40% less decline in their ability to perform daily activities. It also reduced levels of tau, a protein linked to Alzheimer's progression. Another study demonstrated that donanemab improved scores on memory and thinking tests, indicating it can help maintain these functions for longer.23467
Who Is on the Research Team?
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Principal Investigator
Eli Lilly and Company
Are You a Good Fit for This Trial?
This trial is for people with early cognitive decline and signs of both amyloid and alpha-synuclein in their brain, such as those with Lewy body dementia. Participants need to have a reliable study partner, show gradual memory or thinking problems for at least 6 months, and score at least 20 on a common cognitive test.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive donanemab or placebo via intravenous infusion to assess the impact on cognitive and functional decline
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Donanemab
Trial Overview
The study tests whether donanemab can slow down memory and daily function loss compared to a placebo (inactive treatment). Participants are randomly assigned to receive either donanemab or placebo over about one and a half years.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Donanemab (LY3002813) administered as an intravenous (IV) infusion
Placebo administered IV
Find a Clinic Near You
Who Is Running the Clinical Trial?
Eli Lilly and Company
Lead Sponsor
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
Donanemab for Alzheimer's Disease: A Systematic Review of ...
Other favorable outcomes were a reduction in the accumulation of overall tau levels and relatively lower functional/cognitive decline with Donanemab. Further ...
2.
investor.lilly.com
investor.lilly.com/news-releases/news-release-details/lillys-donanemab-significantly-slowed-cognitive-and-functionalLilly's Donanemab Significantly Slowed Cognitive and ...
Donanemab treatment slowed clinical decline by 35% compared to placebo, and resulted in 40% less decline on the ability to perform activities of daily living.
Trial of Donanemab in Early Symptomatic Alzheimer Disease
In this phase 3 trial, donanemab significantly slowed Alzheimer disease progression, based on the iADRS score, compared with placebo in the low/ ...
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, ...
Donanemab Approved for Treatment of Early Alzheimer's
There is no evidence to date that this or any treatment can restore or reverse memory loss or cognitive function due to Alzheimer's disease. In the study ...
Donanemab: Appropriate use recommendations
There are limited data to inform the safety of donanemab use in patients requiring chronic anticoagulation. Anticoagulants, including warfarin, vitamin K ...
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.
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