Clincosm LogoSign in Get a demo

Thalidomide for Patients With Mild to Moderate Alzheimer's Disease

Sponsor
Banner Health (Other)
Overall Status
Unknown status
CT.gov ID
NCT01094340
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
34.1
Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

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 Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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
Study Start Date :
Mar 1, 2010
Anticipated Primary Completion Date :
Dec 1, 2012
Anticipated Study Completion Date :
Jan 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Other: Thalidoide

CSF

Drug: Thalidomide
fixed dose over 8 clinic visits
Other Names:
  • Celegene

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Improve cognition [2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Banner Sun Health Research Institute Sun City Arizona United States 85351

    Sponsors and Collaborators

    • Banner Health

    Investigators

    • Study Director: Carolyn Liebsack, BSN, Banner Health

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Brian Browne, MARWAN SABBAGH, MD Director, Banner Health
    ClinicalTrials.gov Identifier:
    NCT01094340
    Other Study ID Numbers:
    • 1R01AG034155-01
    First Posted:
    Mar 26, 2010
    Last Update Posted:
    Aug 8, 2012
    Last Verified:
    Aug 1, 2012
    Additional relevant MeSH terms:
    Alzheimer Disease
    Thalidomide

    Study Results

    No Results Posted as of Aug 8, 2012