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
  Purpose

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 Intervention Phase
Alzheimer's Disease
Drug: Thalidomide
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Banner Health:

Primary Outcome Measures:
  • Improve cognition [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: March 2010
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Thalidoide
CSF
Drug: Thalidomide
fixed dose over 8 clinic visits
Other Name: Celegene

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.

  Eligibility

Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01094340

Locations
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
Study Director: Carolyn Liebsack, BSN Banner Sun Health Research Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Brian Browne, MARWAN SABBAGH, MD Director, Banner Health
ClinicalTrials.gov Identifier: NCT01094340     History of Changes
Other Study ID Numbers: 1R01AG034155-01
Study First Received: March 25, 2010
Last Updated: August 6, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Alzheimer Disease
Angiogenesis Inhibitors
Growth Inhibitors
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Thalidomide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Angiogenesis Modulating Agents
Growth Substances
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 28, 2014