Efficacy and safety of the novel GlyT1 inhibitor BI 425809 in Alzheimer's dementia: a randomized controlled trial.

ABSTRACT:

Background

This phase II proof-of-concept study assessed the efficacy and safety of BI 425809, a novel selective glycine transporter-1 inhibitor, for the treatment of cognitive impairment associated with probable Alzheimer's disease dementia.

Methods

This 12-week, multicenter, double-blind, placebo-controlled, parallel-group study randomized (1:1:1:1:1) patients with mild-to-moderate probable Alzheimer's disease dementia to BI 425809 2, 5, 10, and 25 mg or placebo once daily. The primary efficacy endpoint was the change from baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale 11-item total score after 12 weeks of treatment. Safety was also assessed.

Results

Six hundred and ten male and female patients were randomized to BI 425809 2 mg (n = 123), 5 mg (

SUBMITTER: Wunderlich G 

PROVIDER: S-EPMC9883916 | biostudies-literature | 2023 Jan

REPOSITORIES: biostudies-literature