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Thalidomide for Patients With Mild to Moderate Alzheimer's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01094340
Recruitment Status : Unknown
Verified August 2012 by Brian Browne, Banner Health.
Recruitment status was:  Recruiting
First Posted : March 26, 2010
Last Update Posted : August 8, 2012
Sponsor:
Information provided by (Responsible Party):
Brian Browne, Banner Health

Study Description
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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
Alzheimer's Disease Drug: Thalidomide 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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : March 2010
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Thalidomide

Arms and Interventions
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Arm Intervention/treatment
Thalidoide
CSF
 Drug: Thalidomide
fixed dose over 8 clinic visits
Other Name: Celegene


Outcome Measures
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Primary Outcome Measures :
  1. Improve cognition [ Time Frame: 2 years ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01094340


Locations
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United States, Arizona
Banner Sun Health Research Institute Recruiting
Sun City, Arizona, United States, 85351
Contact: Marwan Sabbagh, MD    623-832-6500    marwan.sabbagh@bannerhealth.com   
Principal Investigator: Marwan N Sabbagh, MD         
Sponsors and Collaborators
Banner Health
Investigators
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Study Director: Carolyn Liebsack, BSN Banner Health
More Information
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Responsible Party: Brian Browne, MARWAN SABBAGH, MD Director, Banner Health
ClinicalTrials.gov Identifier: NCT01094340    
Other Study ID Numbers: 1R01AG034155-01 ( U.S. NIH Grant/Contract )
First Posted: March 26, 2010    Key Record Dates
Last Update Posted: August 8, 2012
Last Verified: August 2012
Additional relevant MeSH terms:
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Alzheimer Disease
Angiogenesis Inhibitors
Growth Inhibitors
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
 Thalidomide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Modulating Agents
Growth Substances
Antineoplastic Agents