Thalidomide for Patients With Mild to Moderate Alzheimer's Disease

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Status and phase

Unknown

Phase 3

Phase 2

Conditions

Alzheimer's Disease

Treatments

Drug: Thalidomide

Study type

Interventional

Funder types

Other

Identifiers

NCT01094340

1R01AG034155-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

50 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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