Thalidomide for Patients With Mild to Moderate Alzheimer's Disease

Banner Health20 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Alzheimer's Disease

Interventions

ThalidomideDRUG

fixed dose over 8 clinic visits

Eligibility

Sex: ALLMin age: 50 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

Banner Sun Health Research Institute

Sun City, Arizona, United States

RECRUITING

Outcomes

Primary Outcomes

Improve cognition

Time frame: 2 years

Data from ClinicalTrials.gov

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