Thalidomide for Patients With Mild to Moderate Alzheimer's Disease

Alzheimer's Disease Clinical Trial

Official title:

"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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01094340
• Other study ID #: 1R01AG034155-01
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: March 25, 2010
• Last updated: August 6, 2012
• Start date: March 2010
• Est. completion date: January 2013

Study information

• Verified date: August 2012
• Source: Banner Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: January 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• Thalidomide
fixed dose over 8 clinic visits

Locations

Country	Name	City	State
United States	Banner Sun Health Research Institute	Sun City	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Banner Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improve cognition		2 years	No

External Links

•   Banner Sun Health Research Institute Website