NCT01094340

Thalidomide for Patients With Mild to Moderate Alzheimer's Disease

"Twenty-Four-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Effect of Fixed Dose Regimens of Thalidomide and Placebo on CSF and Plasma Biomarkers in Patients With Mild to Moderate Alzheimer's Disease

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Banner Health · Academic / Other
• Sex: All
• Age: 50 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

This is a 24-week, randomized, double-blind, placebo-controlled study of the effect of thalidomide and placebo on CSF (cerebral spinal fluid) and plasma biomarkers in patients with mild to moderate Alzheimer's disease. This study will evaluate the effects of 24 weeks of treatment with Thalidomide on plasma biomarkers.

Detailed description

A lumbar puncture will be done before treatment (baseline), and at 24 weeks to collect CSF for the quantification of biomarkers. As an exploratory effort, we will test the effects of thalidomide on the same biomarkers in the plasma and will determine if detectable changes mirror changes observed in the CSF.

Conditions

• Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	Thalidomide	fixed dose over 8 clinic visits

Timeline

• Start date: 2010-03-01
• Primary completion: 2012-12-01
• Completion: 2013-01-01
• First posted: 2010-03-26
• Last updated: 2012-08-08

Locations

1 site across 1 country: United States