A Phase 2a Study to Evaluate the Effect of Rilapladib (SB-659032) in Alzheimer's Disease

Phase 2 Completed 124 enrolled GlaxoSmithKline

RandomizedParallel-groupTriple-blindTreatment

Summary

The study is designed to investigate the effects of rilapladib on biomarkers related to the Alzheimer's disease, and cognitive function.

Timeline

Start: 2011-10-01
Primary completion: 2013-02-04
Completion: 2013-02-18

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Placebo Once Daily vs Rilapladib 250 mg Once Daily; p = 0.133; Mean Difference (Net) 39.8 (95% CI -12.4 to 92.0); ANCOVA NCT01428453 ↗

registry analysis (superiority or other test); Placebo Once Daily vs Rilapladib 250 mg Once Daily; p = 0.026; Mean Difference (Net) 0.167 (95% CI 0.021 to 0.313); Mixed-Model Repeated Measures analysis NCT01428453 ↗

Publications

Maher-Edwards G, De'Ath J, Barnett C, Lavrov A, Lockhart A. A 24-week study to evaluate the effect of rilapladib on cognition and cerebrospinal fluid biomarkers of Alzheimer's disease. Alzheimers Dement (N Y). 2015 Jun 30;1(2):131-140. doi: 10.1016/j.trci.2015.06.003. eCollection 2015 Sep.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Rilapladib	Small molecule	250 mg	—