Evidence review finds anti-amyloid Alzheimer’s drugs show no clinically meaningful benefit
A major evidence review of 17 clinical trials involving more than 20,000 participants found anti-amyloid Alzheimer’s drugs had absent or trivial effects on cognitive decline and dementia. The review also said the drugs likely increase the risk of brain swelling and bleeding.
New anti-amyloid drugs approved to treat Alzheimer’s disease have no clinically meaningful positive effects for patients, a major evidence review has concluded. Drugs like Leqembi (lecanemab) and Kinsula (donanemab) have little to no effect on patients’ cognitive decline and dementia, according to results published by the Cochrane Review. Researchers concluded that the absolute effects of anti-amyloid drugs on cognitive decline and dementia were “absent or trivial,” falling well below the standard for clinical effectiveness.
For the review, researchers analyzed data from 17 clinical trials involving more than 20,000 participants, all looking at how anti-amyloid drugs affected people with mild cognitive impairment or mild dementia due to Alzheimer’s. The trials tested the effectiveness of aducanumab, bapineuzumab, crenezumab, donanemab, gantenerumab, lecanemab, ponezumab, remternetug and solanezumab. These drugs target amyloid beta, a protein that forms toxic clumps in the brains of people with Alzheimer’s.
The drugs do successfully remove amyloid from the brain, but that doesn’t lead to meaningful cognitive benefits for patients, researchers said. Anti-amyloid drugs also likely increase the risk of dangerous swelling and bleeding in the brain, the team noted. The team recommended that future Alzheimer’s research focus on other targets than amyloid beta, as future trials targeting the protein are unlikely to provide clear benefit to patients.
The maker of Leqembi and the Alzheimer’s Association took issue with the review because it included data from failed anti-amyloid drugs alongside studies of drugs that achieved U.S. government approval. The company said the meta-analysis was “scientifically deeply flawed” by combining ineffective antibodies and failed studies with effective, regulatory approved anti-amyloid treatments. The association said multiple regulatory agencies around the world have approved treatments in this class based on clinical trial data showing significant and “clinically meaningful” slowing of decline in early Alzheimer’s patients.