Recruiting
Phase 2
Phase 3

Thalidomide

Sponsor:

Banner Health

Code:

NCT01094340

Conditions

Alzheimer's Disease

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

Thalidomide

Study Details

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.

Conditions

Alzheimer's Disease

Study ID

NCT01094340

Start date

Mar, 2010

Status verified date

Aug, 2012

Completion date

Jan, 2013

Anticipated

Primary completion date

Dec, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Thalidoide

CSF

Interventions

Thalidomide

fixed dose over 8 clinic visits

Primary outcome measure

  • Improve cognition [ Time Frame: 2 years ]

Central Contacts and Locations

Locations

Banner Sun Health Research Institute

Recruiting

Sun City, Arizona, United States, 85351

Contacts

Marwan Sabbagh, MD

623-832-6500marwan.sabbagh@bannerhealth.com

Principal Investigator:

Marwan N Sabbagh, MD

More Information

Sponsor

Banner Health

Last update posted

Aug 8, 2012

Last verified

Aug, 2012

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Banner Health on 2012-08-08.