Double-blind placebo-controlled study of velnacrine in Alzheimer's disease.

The present study assessed the safety and efficacy of the cholinesterase inhibitor, velnacrine, for treating the cognitive symptoms of Alzheimer's disease. 236 patients meeting NINCDS-ADRDA criteria for Alzheimer's disease entered a double-blind, placebo-controlled dose-ranging protocol to identify velnacrine responders (≥ 4-point improvement on the cognitive subscale of the Alzheimer's Disease Assessment Scale [ADAScog]). After a 2-wk drug washout, velnacrine responders were randomly assigned to their best velnacrine dose or placebo in a 6-wk dose-replication protocol employing the ADAScog and the Clinical Global Improvement scale as primary outcome measures. During dose-replication, intent-to-treat analysis revealed that velnacrine patients scored significantly better than placebo patients on the ADAScog after 2, 4, and 6 wks of treatment. No significant treatment effect on Clinical Global Improvement scores was observed. The present study identified a subgroup of Alzheimer's patients who demonstrated a significant, but modest, improvement during velnacrine treatment on structured cognitive testing. (PsycINFO Database Record (c) 2016 APA, all rights reserved)