A 1-YEAR MULTICENTER PLACEBO-CONTROLLED STUDY OF ACETYL-L-CARNITINE IN PATIENTS WITH ALZHEIMERS-DISEASE

A 1-year, double-blind, placebo-controlled, randomized, parallel-group study compared the efficacy and safety of acetyl-L-carnitine hydrochl oride (ALCAR) with placebo in patients with probable Alzheimer's disea se (AD). Subjects with mild to moderate probable AD, aged 50 or older, were treated with 3 g/day of ALCAR or placebo (1 g tid) for 12 months . Four hundred thirty-one patients entered the study, and 83% complete d 1 year of treatment, The Alzheimer's Disease Assessment Scale cognit ive component and the Clinical Dementia Rating Scale were the primary outcome measures. Overall, both ALCAR- and placebo-treated patients de clined at the same rate on all primary and most secondary measures dur ing the trial. In a subanalysis by age that compared early-onset patie nts (aged 65 years or younger at study entry) with late-onset patients (older than 66 at study entry), we found a trend for early-onset pati ents on ALCAR to decline more slowly than early-onset AD patients on p lacebo on both primary endpoints. In addition, early-onset patients te nded to decline more rapidly than older patients in the placebo groups . Conversely, late-onset-AD patients on ALCAR tended to progress more rapidly than similarly treated early-onset patients. The drug was very well tolerated during the trial. The study suggests that a subgroup o f AD patients aged 65 or younger may benefit from treatment with ALCAR whereas older individuals might do more poorly. However, these prelim inary findings are based on post hoc analyses, A prospective trial of ALCAR in younger patients is underway to test the hypothesis that youn g, rapidly progressing subjects will benefit from ALCAR treatment.