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A randomized controlled trial shows that chronic low-dose naproxen does not reduce progression of presymptomatic Alzheimer disease (AD).
The INTREPAD trial was a 2-year double-masked prevention trial, that enrolled 195 AD who were randomized 1:1 to naproxen sodium 220 mg twice daily or placebo. The primary outcome was rate of change in a multimodal composite presymptomatic Alzheimer Progression Score (APS).
The most striking result was that naproxen-treated individuals showed a clear excess of adverse events.
There was no significant difference in outcome AD measures (APS) between treatment groups. The treatment-related rate ratio of 1.16 (95% confidence interval 0.64–1.96) suggested that naproxen (220 mg twice daily) does not reduce the rate of APS progression by more than 36%. Secondary analyses revealed no benefits on on CSF, cognitive, or neurosensory biomarker indicators of progressive presymptomatic AD patients treated with naproxen.
Low-dose naproxen failed to reduce progression of presymptomatic AD.