Thalidomide for Patients With Mild to Moderate Alzheimer's Disease

Phase 2

• Conditions: Alzheimer's Disease
• Interventions: Drug: Thalidomide

• Registration Number: NCT01094340
• Lead Sponsor: Banner Health

Brief 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.

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-03-25
• Study First Submitted QC: 2010-03-25
• Study First Posted: 2010-03-26
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-06
• Last Update Posted: 2012-08-08
• Primary Completion: 2012-12
• Study Completion: 2013-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Subjects must have a screening diagnosis of Probable Alzheimer's disease according to National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria.
• Subjects must have a Mini-Mental State Examination (MMSE) score of 12-26
• Subject must live at home.
• Must have a caregiver to participate in this study

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Thalidoide	Thalidomide	CSF

Primary Outcome Measures

Name	Time	Method
Improve cognition	2 years

Trial Locations

Locations (1)

Banner Sun Health Research Institute; 🇺🇸 Sun City, Arizona, United States