Safety and Efficacy of Edonerpic Maleate for Patients With Mild to Moderate Alzheimer Disease: A Phase 2 Randomized Clinical Trial.

ABSTRACT:

Importance

Edonerpic maleate (T-817MA) protects against Aβ40-induced neurotoxic effects and memory deficits, promotes neurite outgrowth, and preserves hippocampal synapses and spatial memory in tau transgenic mice. These effects may be mediated via sigma-1 receptor activation, delivery of synaptic AMPA receptors, or modulation of microglial function and may benefit patients with Alzheimer disease.

Objective

To assess the efficacy, safety, and tolerability of edonerpic for patients with mild to moderate Alzheimer disease.

Design, setting, and participants

Randomized, double-blind, placebo-controlled, parallel-group, phase 2 clinical trial conducted over 52 weeks from June 2, 2014, to December 14, 2016, at 52 US clinical and academic centers. Of 822 outpatients screened

SUBMITTER: Schneider LS 

PROVIDER: S-EPMC6618817 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature