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P3–462: A randomized, double–blind, placebo controlled–trial of triflusal in mild cognitive impairment
Author(s) -
Gomez-Isla Teresa,
Muñoz Genı́s,
Ferro Jose M.,
Lage José Manuel Martı́nez,
Ramı́rez José Carlos Navas
Publication year - 2006
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.2006.05.1733
Subject(s) - placebo , dementia , medicine , randomized controlled trial , neuropsychology , clinical trial , cognitive decline , cognition , disease , physical therapy , psychiatry , pathology , alternative medicine
active, 5 placebo) for 28 days. Safety evaluations included adverse events (AE), vital signs, ECG, and lab tests; patients also were administered the ADAS-Cog at baseline and day 28. Lecozotan pharmacokinetics were determined by noncompartmental analysis on days 1 and 28. Results: Lecozotan was well tolerated after multiple dosing for 28 days. Most AEs were mild to moderate in severity and included headache, dizziness, constipation, insomnia, and pruritus. One serious AE (lacunar infarct) occurred in the lecozotan-treated group. AE frequency was substantially reduced in the SR-treated group compared with the IR-treated group. Lecozotan tmax was 1.5 hour (IR) and 4-8 hours (SR). Elimination t1/2 was 7 14 hours. Linear dose proportionality was seen for Cmax and AUC over the 0.5 to 5.0 mg dose range. Based on AUC0, lecozotan SR was bioequivalent to IR. ADAS-Cog results showed a trend toward improvement over baseline at day 28 for the groups receiving 10mg/day lecozotan. Conclusions: Lecozotan appeared to be safe in AD subjects up to daily doses of 10 mg. There were no significant differences in the elimination properties of lecozotan between the two formulations. The SR formulation was better tolerated than the IR formulation, possibly due to reduced lecozotan peak plasma concentration.