A Phase 2 clinical trial of PF-05212377 (SAM-760) in subjects with mild to moderate Alzheimer's disease with existing neuropsychiatric symptoms on a stable daily dose of donepezil.

ABSTRACT:

Background

Symptomatic benefits have been reported for 5-HT₆ receptor antagonists in Alzheimer's disease (AD) trials. SAM-760 is a potent and selective 5-HT₆ receptor antagonist that has demonstrated central 5-HT₆ receptor saturation in humans at a dose of 30 mg.

Methods

This was a randomized, double-blind, placebo-controlled, parallel-group, multicenter trial evaluating the efficacy and safety of SAM-760 30 mg once daily (QD) for 12 weeks in subjects with AD on a stable regimen of donepezil 5 to 10 mg QD. The study included an interim analysis with stopping rules for futility or efficacy after 180 subjects completed the week 12 visit. Up to 342 subjects with AD (Mini-Mental State Examination (MMSE) score 10-24) and neuropsychiatric symptoms

SUBMITTER: Fullerton T 

PROVIDER: S-EPMC5887246 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature