Safety, tolerability, and efficacy of bepranemab in people living with prodromal-to-mild Alzheimer's disease: a randomised, double-blind, placebo-controlled, phase 2 trial.

Bepranemab in prodromal-to-mild Alzheimer’s disease did not meet the primary endpoint: CDR-SB change at week 80 was 2·15 (90 mg/kg) and 1·85 (45 mg/kg) vs 1·81 with placebo.

• Why it matters: Tau mid-region targeting is intended to better block tau spread, but prior N-terminal tau antibodies have not slowed tau progression or cognitive decline, leaving an unmet need for effective tau-directed therapy.
• What they did: In a phase 2 randomized, double-blind, placebo-controlled trial across 101 outpatient sites (Europe, Canada, USA), participants aged 50–80 received IV bepranemab 45 mg/kg, 90 mg/kg, or placebo every 4 weeks for 76 weeks, with CDR-SB as the primary endpoint.
• The result: Safety was acceptable with treatment-emergent adverse events similar to placebo (91% for both bepranemab doses vs 90% placebo) and no treatment-related neuroinflammatory signals on MRI; however, placebo differences were small and not significant (p=0·12 for 90 mg/kg, p=0·87 for 45 mg/kg).

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