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Thalidomide for Patients With Mild to Moderate Alzheimer's Disease

NCT ID: NCT01094340

Last Updated: 2012-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2013-01-31

Brief Summary

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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

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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.

Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Thalidoide

CSF

Group Type OTHER

Thalidomide

Intervention Type DRUG

fixed dose over 8 clinic visits

Interventions

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Thalidomide

fixed dose over 8 clinic visits

Intervention Type DRUG

Other Intervention Names

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Celegene

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Banner Health

OTHER

Sponsor Role lead

Responsible Party

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Brian Browne

MARWAN SABBAGH, MD Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Carolyn Liebsack, BSN

Role: STUDY_DIRECTOR

Banner Health

Locations

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Banner Sun Health Research Institute

Sun City, Arizona, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Marwan Sabbagh, MD

Role: primary

Other Identifiers

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1R01AG034155-01

Identifier Type: NIH

Identifier Source: org_study_id

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