Anti-Amyloid Alzheimer’s Drugs Face New Doubts: Cochrane Review Finds ‘Trivial’ Effects

A bombshell Cochrane review questions the effectiveness of anti-amyloid Alzheimer’s drugs like Leqembi and Kisunla, calling their benefits “absent or trivial” despite FDA approvals.

Cochrane Analysis: Little to No Clinical Benefit

The nonprofit Cochrane compiled data from 17 placebo-controlled studies on seven amyloid-beta-targeting monoclonal antibodies, involving over 20,000 people with mild cognitive impairment or mild Alzheimer’s dementia.

Key findings at 18 months:

• Cognitive function: Probably little to no difference.
• Functional ability: Small effect at best.
• Dementia severity: May result in little to no difference.

“Successful removal of amyloid from the brain does not seem to be associated with clinically meaningful effects,” the researchers concluded. They urge focusing on other mechanisms beyond amyloid plaques.

Drugs reviewed include failed candidates like Aduhelm, bapineuzumab, crenezumab, gantenerumab, and solanezumab plus approved Leqembi (Biogen/Eisai) and Kisunla (Eli Lilly).

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Pharma Pushback on Leqembi, Kisunla Effectiveness

Eli Lilly slammed the review’s methodology: “It pools data from unsuccessful molecules with approved medicines, artificially diluting benefits.”

Both Leqembi and Kisunla earned full FDA approvals after showing statistically significant reductions in clinical decline in their Phase 3 trials. Still, Cochrane highlights decades of amyloid-targeting setbacks, including 2022 revelations of fabricated research fueling skepticism.

Safety Concerns: Brain Swelling Risks Rise

The drugs “probably result in a small increase” in ARIA-E (brain swelling visible on MRI). Results on ARIA-H (brain bleeding) were too inconsistent for pooling.

Top drugmakers like Biogen, Eisai, and Lilly have invested over a decade in these therapies, securing three FDA nods but this review reignites debates on Alzheimer’s treatment efficacy.