Efficacy and Safety of 3 Doses of S47445 Versus Placebo in Patients With Alzheimer's Disease at Mild to Moderate Stages With Depressive Symptoms

Summary

The purpose of this trial is to assess the efficacy and safety of S47445 versus placebo in patients with Alzheimer's disease at mild to moderate stages with depressive symptoms. An optional 28-week extension period will be performed to evaluate safety/tolerance and efficacy of S47445 in co-administration with donepezil.

Timeline

Start

2015-02

Primary completion

2017-09

Completion

2017-09

Outcome

Missed primary endpoint

paper After 24 weeks, no statistically significant treatment difference was demonstrated between S47445 (5, 15 or 50 mg/d) and placebo on cognition (ADAS-Cog) PMID 31297437 ↗

Publications

• Results Bernard K, Gouttefangeas S, Bretin S, Galtier S, Robert P, Holthoff-Detto V, Cummings J, Pueyo M. A 24-week double-blind placebo-controlled study of the efficacy and safety of the AMPA modulator S47445 in patients with mild to moderate Alzheimer's disease and depressive symptoms. Alzheimers Dement (N Y). 2019 Jun 24;5:231-240. doi: 10.1016/j.trci.2019.04.002. eCollection 2019.

Drugs

Indications