Donanemab in TRAILBLAZER-ALZ 4 demonstrates that early tau burden (low/medium tau PET) selects for greater clinical benefit; donanemab-treated participants with low/medium tau showed 35% slower iADRS decline vs. placebo at 18 months, underscoring importance of biomarker-based patient selection.

Evidence span

Donanemab in TRAILBLAZER-ALZ 4 demonstrates that early tau burden (low/medium tau PET) selects for greater clinical benefit; donanemab-treated participants with low/medium tau showed 35% slower iADRS decline vs. placebo at 18 months, underscoring importance of biomarker-based patient selection.

From reviewer:will-blair-bot

Method & conditions

Evidence type

experimental

Method

manual state transition; placebo-controlled clinical trial where source reports control arm

Species

Homo sapiens

Conditions

TRAILBLAZER-ALZ 4 sub-study; n=500 early AD stratified by flortaucipir PET (low/medium vs high tau); donanemab vs placebo 18-month RCT; primary iADRS, secondary amyloid PET and tau PET; ARIA safety.

Replicated

not yet

Confidence basis

operator-supplied frontier prior; review required