Top Experts Warn Against Speeding Up Approval of Donanemab, Citing Overblown Effects of ‘Game-Changing’ Alzheimer’s Drug

Scientists have cautioned against exaggerated claims that a new drug called Donanemab can significantly slow the progression of Alzheimer’s disease. Eli Lilly, the US pharmaceutical company, recently revealed final trial results suggesting that Donanemab could reduce memory decline by a third. However, critics argue that the drug’s effects may not be noticeable to patients or their families. Donanemab is administered to Alzheimer’s patients via monthly intravenous infusions. The monoclonal antibody binds to toxic amyloid plaque build-ups in the brain, prompting immune cells to clear them. Researchers found that Donanemab slowed cognitive decline by 35% in early-stage Alzheimer’s patients with low or medium levels of tau protein, based on assessments using the integrated Alzheimer’s Disease Rating Scale (iADRS).

During the 18-month trial, patients given a placebo pill experienced a decline of 9.27 points on the iADRS scale, starting at an average score of 105.5 and ending with a score of 96.23. In comparison, patients who received monthly infusions of Donanemab started with a score of 105.7 and ended with a score of 99.5, translating to a 6.02-point drop. The 3.25-point difference between the two groups led Eli Lilly to claim a 35% slowdown in disease progression for those receiving their Alzheimer’s drug. However, critics argue that such a small difference will likely go unnoticed by patients. They caution against rapidly implementing these treatments, citing potential side effects and the need for more effective therapies.

Alzheimer’s disease has been a focus of scientific research for over a century, with numerous approaches explored, including vaccines, antibodies, brain stimulation, oxygen therapy, and stem cells. While experts differ in their interpretations of the Donanemab trial results, Dr Richard Oakley from Alzheimer’s Society describes them as a “turning point” in the fight against Alzheimer’s, envisioning a future where the disease can be managed as a long-term condition. Alzheimer’s disease is a degenerative brain disease characterized by the death of nerve cells due to the accumulation of abnormal proteins. Though there is currently no cure, treatments like Acetylcholinesterase inhibitors and memantine can alleviate symptoms, while non-pharmaceutical approaches like mental training can help improve memory.

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