A major Cochrane review has cast doubt on the safety and effectiveness of amyloid-targeting Alzheimer's drugs, finding their impact on cognitive decline is either non-existent or minimal. The analysis of 17 trials with over 20,000 participants concluded that these monoclonal antibodies, designed to clear amyloid-beta plaques from the brain, do not provide a meaningful clinical benefit to patients.
The researchers, led by Francesco Nonino of the IRCCS Institute of Neurological Sciences in Bologna, Italy, emphasized the distinction between statistically significant results and real-world clinical relevance. They also flagged increased risks of brain swelling and bleeding associated with the drugs.
The Cochrane team recommends exploring other biological pathways for Alzheimer's treatment. However, the findings have been met with strong pushback. The Alzheimer's Association called the analysis "scientifically flawed," and drugmakers Eli Lilly and Eisai, makers of donanemab (Kisunla) and lecanemab (Leqembi) respectively, argued that pooling data from failed and successful therapies creates misleading conclusions. They point to real-world evidence and long-term data showing sustained benefits for patients.