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P1‐299: A phase i, randomized, double‐blind, placebo‐controlled, multiple ascending dose study of AT‐001 yeast selenium for the prevention of Alzheimer's disease
Author(s) -
Jicha Gregory A.,
Abner Erin L.,
Kryscio Richard J.,
Witt Casey,
Yiannikouris Alex,
Johnson Carrie,
Martinez Josh,
Lovell Mark,
Power Ronan
Publication year - 2015
Publication title -
alzheimer's and dementia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 6.713
H-Index - 118
eISSN - 1552-5279
pISSN - 1552-5260
DOI - 10.1016/j.jalz.2015.06.500
Subject(s) - pharmacokinetics , tolerability , medicine , placebo , dosing , oxidative stress , adverse effect , pharmacology , alzheimer's disease , selenium , gastroenterology , disease , pathology , chemistry , alternative medicine , organic chemistry
range of 69.0%, 1-step titration was determined to be as well-tolerated as 3-step titration. Secondary endpoints included efficacy parameters: AD Assessment Scale Japan-Cognitive Subscale, MMSE, and Japanese-Clinical Global Impression of Change. Results:Of 216 patients randomized, 170 patients (78.7%) completed the study. All but one of the randomized patients were included in the safety analysis (1-step, 107; 3-step, 108). The proportion of patients discontinuing treatment due to AEs was 15.0% (16/107) in the 1-step group and 18.5% (20/108) in the 3-step group. The observed difference between treatments of the proportion of discontinuation due to AEs (1-step titration group – 3-step titration group) was 3.6% (95% confidence interval: 17.0, 9.6). Since the point-estimate of the observed difference falls within the pre-specified range, the study met its primary objective. The reported AEs were similar between the groups. The study showed similar efficacy between both groups at Week 24. Conclusions:These data support the use of a 1-step titration schedule for Japanese patients with mild-to-moderate AD.