Back to resultsThalidomide for Patients With Mild to Moderate Alzheimer's Disease
Primary Purpose
Alzheimer's Disease
Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Thalidomide
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer's Disease
Eligibility Criteria
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
Sites / Locations
- Banner Sun Health Research InstituteRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Thalidoide
Arm Description
CSF
Outcomes
Primary Outcome Measures
Improve cognition
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01094340
Brief Title
Thalidomide for Patients With Mild to Moderate Alzheimer's Disease
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 Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Unknown status
Study Start Date
March 2010 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
January 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Banner Health
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Thalidoide
Arm Type
Other
Arm Description
CSF
Intervention Type
Drug
Intervention Name(s)
Thalidomide
Other Intervention Name(s)
Celegene
Intervention Description
fixed dose over 8 clinic visits
Primary Outcome Measure Information:
Title
Improve cognition
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carolyn Liebsack, BSN
Organizational Affiliation
Banner Health
Official's Role
Study Director
Facility Information:
Facility Name
Banner Sun Health Research Institute
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marwan Sabbagh, MD
Phone
623-832-6500
Email
marwan.sabbagh@bannerhealth.com
First Name & Middle Initial & Last Name & Degree
Marwan N Sabbagh, MD
12. IPD Sharing Statement
Learn more about this trial
Thalidomide for Patients With Mild to Moderate Alzheimer's Disease
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