BI 425809 in Patients With Cognitive Impairment Due to Alzheimer's Disease.

Phase 2 Completed 611 enrolled Boehringer Ingelheim

RandomizedParallel-groupDouble-blindTreatment

Summary

The study is designed to compare the effects of BI 425809 compared to placebo in patients with cognitive impairment due to Alzheimer's Disease.

Timeline

Start: 2016-08-11
Primary completion: 2019-09-12
Completion: 2019-10-11

Outcome

Missed primary endpoint

paper No significant, non-flat dose-response relationship was detected for the primary endpoint (adjusted p-value > 0.76 for all models). PMID 36709275 ↗

Publications

Wunderlich G, Blahova Z, Garcia M, Jessen F. Efficacy and safety of the novel GlyT1 inhibitor BI 425809 in Alzheimer's dementia: a randomized controlled trial. Alzheimers Res Ther. 2023 Jan 28;15(1):24. doi: 10.1186/s13195-023-01163-3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	BI 425809	Unknown	2 mg	Oral
Subject	BI 425809	Unknown	5 mg	Oral
Subject	BI 425809	Unknown	10 mg	Oral
Subject	BI 425809	Unknown	25 mg	Oral