Are there clinical trials for Alzheimer’s patients whose plaque is cleared?
June 27
What are the clinical trial findings for donanemab (Kisunla) after amyloid plaque clearance in Alzheimer's disease?
Donanemab (Kisunla) received full FDA approval in July 2024. It works by targeting and clearing amyloid beta plaques from the brain, which are a hallmark feature of Alzheimer's disease. Long-term follow-up Show Full Answer
What are the clinical trial findings for donanemab (Kisunla) after amyloid plaque clearance in Alzheimer's disease?
Donanemab (Kisunla) received full FDA approval in July 2024. It works by targeting and clearing amyloid beta plaques from the brain, which are a hallmark feature of Alzheimer's disease. Long-term follow-up studies have shown some encouraging results after treatment:
- People treated with donanemab showed a 1.2-point slower decline in a standard Alzheimer's measure compared to those untreated
- Those who started treatment early had a 27% lower risk of progressing to the next stage of Alzheimer's
- Benefits of treatment appeared to grow over time
These are meaningful findings, especially since for decades, treatments mainly managed symptoms without affecting the underlying disease. However, there are important safety considerations to be aware of:
- About 35% of people taking donanemab may develop brain swelling or small bleeds (seen on MRI scans)
- A modified dosing schedule may reduce this risk by as much as 41%
- Regular brain monitoring is required throughout treatment
- Other potential side effects include headache, increased risk of falls, and allergic reactions
It's important to note that donanemab is not a cure, and comes with practical challenges like IV infusions, testing requirements, and high costs. Speaking with a healthcare provider is the best way to explore whether this treatment is right for a specific situation.
June 27