BI 409306 in Patients With Cognitive Impairment Due to Alzheimer's Disease.

Phase 2 Completed 329 enrolled Boehringer Ingelheim

RandomizedParallel-groupDouble-blindTreatment

Summary

The study is designed to compare the effects of BI 409306 compared to placebo in patients with cognitive impairment due to Alzheimer's Disease

Timeline

Start: 2015-01-21
Primary completion: 2017-09-15
Completion: 2017-10-10

Outcome

Missed primary endpoint

registry analysis (superiority test); Pooled BI 409306 vs Placebo Matching BI 409306; p = 0.5687; Mean Difference (Final Values) -0.03 (95% CI -0.135 to 0.074) NCT02337907 ↗

registry analysis (superiority test); Pooled BI 409306 vs Placebo Matching BI 409306; p = 0.6492; Mean Difference (Final Values) -0.02 (95% CI -0.098 to 0.061) NCT02337907 ↗

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
Comparator	Donepezil	Small molecule	—	—
Subject	OSORESNONTRINE	Small molecule	—	Oral