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

Alzheimer's Disease Clinical Trial

Official title: A Phase 2a Study to Evaluate the Effect of Rilapladib (SB-659032) on Biomarkers Related to the Pathogenesis and Progression of Alzheimer's Disease

Status Completed

Clinical Trial Summary

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

Clinical Trial Description

The study is in subjects with Alzheimer's disease and evidence of cerebrovascular disease (CVD) who are currently treated with an acetylcholinesterase inhibitor (AChEI) and/or memantine. The study is a randomized, double-blind, placebo controlled, parallel group, repeat dose design, in which subjects (up to 60 randomized subjects per arm) will receive oral placebo or rilapladib (250 mg), once daily for 24 weeks in addition to their stable background AD therapy consisting of an acetylcholinesterase inhibitor (AChEI) and/or memantine. Subjects will take 250mg of rilapladib or placebo once daily for a period of 24 weeks. The total duration of participation for each subject will be approximately 30 weeks comprising approximately 4 weeks screening, 24 weeks treatment and 2 weeks follow-up. From the time of randomization and throughout the treatment period subjects will attend visits after 1 week, 4 weeks and thereafter every 4 weeks until Week 24. A follow-up visit will occur approximately 2 weeks after the final dose of study medication. Cognitive assessments will be performed at the screening visit, at the randomization (baseline) visit and at weeks 12 and 24 of the treatment period. Cerebrospinal fluid (CSF) samples will be taken via lumbar puncture at baseline and Week 24 for biomarker analyses related to Alzheimer's disease. Blood samples will be collected throughout the study for pharmacokinetics and a range of biomarker analyses. A range of safety and tolerability assessments will also be performed (including vital signs, laboratory tests, eye examinations and ECGs). ;

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

• NCT number: NCT01428453
• Study type: Interventional
• Source: GlaxoSmithKline
• Status: Completed
• Phase: Phase 2
• Start date: October 1, 2011
• Completion date: February 18, 2013