Thalidomide for Patients With Mild to Moderate Alzheimer's Disease

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

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01094340

Enrollment

Registered

2010-03-26

Start date

2010-03-31

Completion date

2013-01-31

Last updated

2012-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease

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.

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.

Interventions

DRUGThalidomide

fixed dose over 8 clinic visits

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

50 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Improve cognition	2 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026