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Thalidomide for Patients With Mild to Moderate Alzheimer's Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Banner Health.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Brian Browne, Banner Health
ClinicalTrials.gov Identifier:
NCT01094340
First received: March 25, 2010
Last updated: August 6, 2012
Last verified: August 2012

March 25, 2010
August 6, 2012
March 2010
December 2012   (final data collection date for primary outcome measure)
Improve cognition [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01094340 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Alzheimer's Disease
Drug: Thalidomide
fixed dose over 8 clinic visits
Other Name: Celegene
Thalidoide
CSF
Intervention: Drug: Thalidomide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
January 2013
December 2012   (final data collection date for primary outcome measure)

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
Both
50 Years to 90 Years
No
United States
 
NCT01094340
1R01AG034155-01
Yes
Brian Browne, Banner Health
Banner Health
Not Provided
Study Director: Carolyn Liebsack, BSN Banner Sun Health Research Institute
Banner Health
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP