Evaluation of the Efficacy of Varenicline on Cognition, Safety, Tolerability and Pharmacokinetics in Subjects With Mild-to-Moderate Alzheimer's Disease

Summary

1. Assess the efficacy of varenicline, relative to placebo, on a performance based measure of cognition in patients with mild to moderate Alzheimer's disease 2. Evaluate the effects of varenicline on clinically relevant measures including attention and executive function, behavior, and clinician rated global change. 3. Evaluate the safety and tolerability of varenicline, relative to placebo, in patients with mild to moderate Alzheimer's disease 4. Evaluate the pharmacokinetics of varenicline in patients with mild to moderate Alzheimer's disease.

Timeline

Start

2009-07

Primary completion

2010-11

Completion

2010-11

Outcome

Missed primary endpoint

paper there was no significant difference in the week 6 least square (LS) mean ADAS-Cog 75 total score (primary endpoint; 18.07 vs. 18.49; p = 0.3873) PMID 24247022 ↗

Publications

• Kim SY, Choi SH, Rollema H, Schwam EM, McRae T, Dubrava S, Jacobsen J. Phase II crossover trial of varenicline in mild-to-moderate Alzheimer's disease. Dement Geriatr Cogn Disord. 2014;37(3-4):232-45. doi: 10.1159/000355373. Epub 2013 Nov 14.

Drugs

Indications