Alzheimer Disease Proof of Concept Study With BI 409306 Versus Placebo

Summary

The study is designed to compare the effects of 4 different doses of orally administered BI 409306 to placebo in patients with Alzheimers Disease

Timeline

Start

2015-01-15

Primary completion

2017-09-18

Completion

2017-10-09

Outcome

Missed primary endpoint

registry Pooled BI 409306 vs Placebo Matching BI 409306; p = 0.7905; Mean Difference (Final Values) 0.01 (95% CI -0.092 to 0.121) NCT02240693 ↗

registry Pooled BI 409306 vs Placebo Matching BI 409306; p = 0.6492; Mean Difference (Final Values) -0.02 (95% CI -0.098 to 0.061) NCT02240693 ↗

Publications

• Frolich L, Wunderlich G, Thamer C, Roehrle M, Garcia M Jr, Dubois B. Evaluation of the efficacy, safety and tolerability of orally administered BI 409306, a novel phosphodiesterase type 9 inhibitor, in two randomised controlled phase II studies in patients with prodromal and mild Alzheimer's disease. Alzheimers Res Ther. 2019 Feb 12;11(1):18. doi: 10.1186/s13195-019-0467-2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	OSORESNONTRINE	Small molecule	10 mg	Oral
Subject	OSORESNONTRINE	Small molecule	50 mg	Oral

Indications