A Placebo-Controlled Study of Acetyl-L-Carnitine in Patients with
Alzheimer's Disease

A Multi-Center Study -- Industry sponsored
contract

This randomized, placebo-controlled, double-blind, multi-centered study was designed to compare the efficacy and safety of acetyl-l-carnitine during twelve months of treatment in patients with the diagnosis of probable Alzheimer's disease. Centralized data entry at the CTDMC was utilized on the project. This four-year project included a 12-month extension phase offered to those patients completing the twelve-month double-blind phase. The CTDMC was responsible for data management and analyses for this study. A Final Report containing efficacy and safety analyses, descriptions of the study and CTDMC procedures, and complete data listings and documentation, suitable for submission to the FDA, was prepared by the CTDMC and forwarded to the sponsoring organization. Results of the study have been published (Neurology 1996; 47:705-711).