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Getting the latest healthcare news for you
The long-term benefits of lecanemab and donanemab — the two FDA-approved Alzheimer's drugs — are under fresh scrutiny. A reanalysis published in BMJ Neurology Open found that cognitive decline accelerated during open-label extension phases, matching placebo-level rates from the original trials. Critics say claims of increasing benefit over time don't hold up without a true long-term placebo comparison.
The case for lecanemab and donanemab as long-term Alzheimer's treatments just got shakier. A reanalysis published in BMJ Neurology Open found that cognitive decline steepened during the open-label extension (OLE) phases of both drugs' pivotal trials — and that the rate of decline during those extensions was comparable to what placebo patients experienced during the original controlled trials. That's notable because the drug makers had pointed to OLE data as evidence of growing benefit over time.
The catch? Those OLE comparisons were made against historical control groups, not a live placebo arm. The reanalysis, led by researchers at the University of Cincinnati, used two independent methods — simulated patient trajectories and direct annualized decline comparisons — and both pointed in the same direction. Patients who switched from placebo to active treatment during the OLE showed no meaningful improvement in their rate of decline, suggesting the original benefit may have been partly a placebo effect that faded once blinding ended.
Key Takeaways:
Why it matters: Long-term benefit claims for these drugs rest on comparisons with historical cohorts rather than a randomized placebo arm. For clinicians prescribing these costly, risk-carrying therapies, this reanalysis is a reminder that the evidence base for sustained benefit may need more rigorous long-term study.
