An experimental drug called donanemab has shown promise in slowing the progression of Alzheimer's disease in people with early forms of the condition, according to the results of a phase 3 clinical trial. The drug, which is a monoclonal antibody that targets the beta-amyloid protein involved in Alzheimer's, was presented at the Alzheimer’s Association International Conference. However, there were potential side effects of swelling and bleeding in the brain.
This news comes after the recent full approval by the FDA of a similar drug called lecanemab, also a monoclonal antibody that targets beta-amyloid. Lecanemab received accelerated FDA approval in January 2023, and the approval was upgraded when phase 3 results confirmed the clinical benefits of the drug.
Both drugs have shown to delay the decline in cognitive function and daily functioning in individuals with early Alzheimer's. Donanemab was found to delay the decline by about 4 months, and when looking at individuals with low or medium levels of tau, the decline was delayed by about 8 months. However, those with high levels of tau did not see significant benefits from the drug.
The results also showed that individuals who took donanemab were less likely to progress from mild cognitive impairment to mild dementia, and from mild dementia to moderate dementia.
Despite the promise of these drugs, there are potential risks and limitations. Both drugs have been associated with potentially life-threatening swelling and bleeding in the brain. The benefits seen during the phase 3 trials were modest, and the drugs are not designed for individuals with late-stage dementia. Additionally, the cost of these treatments may be a barrier for some individuals, and access to the drugs may be limited due to factors such as regular clinic visits for infusions and lack of insurance coverage for younger individuals.
Experts emphasize the need for personalized and individualized discussions between patients and doctors when considering the use of these drugs. They also highlight the importance of early diagnosis and ongoing monitoring for potential side effects.
In conclusion, while the news of two drugs that can potentially slow Alzheimer's disease symptoms is promising, experts caution that the benefits may be modest, and there are limitations and potential risks associated with these treatments. Further research and development are needed to improve treatment outcomes for Alzheimer's disease.