Clinical Efficacy, Safety and Imaging Effects of Oral Valiltramiprosate in APOEε4/ε4 Homozygotes with Early Alzheimer's Disease: Results of the Phase III, Randomized, Double-Blind, Placebo-Controlled, 78-Week APOLLOE4 Trial.

Drugs · 2025 · PMC12572085 · PMID 41015981

Europe PMC DOI

hedged sentences

0.0410

closest p · 0.8× alpha

0.1000

boldest claim

The sentences

nominally significantp = 0.041actually significant

The prespecified MCI group (MMSE >26, N = 125) showed nominally significant positive effects on ADAS-Cog13 (52%, nominal p = 0.041) and DAD (96%, nominal p = 0.016), positive trend on CDR-SB (102%, nominal p = 0.053), with significant hippocampal atrophy slowing (26%, p = 0.004), and positive grey/white matter effects on MRI-DTI.

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did not achieve significancep < 0.05actually significant

Since the primary clinical outcome did not achieve significance ( p < 0.05), all subsequent p -values for the clinical scores are considered nominal, and were not adjusted for multiplicity testing.

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a positive trendp < 0.1so close (0.05 < p ≤ 0.1)

On ADAS-Cog13, valiltramiprosate showed a positive trend with p < 0.1, starting at MMSE 26–30 with a placebo-adjusted drug effect of 1.84 ( p = 0.067), that is larger than the 1.5–1.7 points achieved with the approved amyloid antibodies [ 31 , 32 ].

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Quoted from the open-access full text in Europe PMC under the licence the publisher applied. The sentence is reproduced exactly as published; the emphasis is ours.