Negative / Null Result ReportOpen accessMedicine· cited by 33

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

Terence Fullerton; Brendon Binneman; William David; Marielle Delnomdedieu; James W. Kupiec; Peter Lockwood; Jessica Mancuso; Jeffrey Miceli · 2018 · Alzheimer s Research & Therapy

WASTE classifies this as Negative / Null Result Report · AI classification, approximate

The study found no significant effect — useful as a negative control or null benchmark for your own design.

Abstract

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. 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 comp

Abstract by Terence Fullerton; Brendon Binneman; William David; Marielle Delnomdedieu; James W. Kupiec; Peter Lockwood; Jessica Mancuso; Jeffrey Miceli, Alzheimer s Research & Therapy (2018) — licensed CC BY 4.0.

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