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Phase II Study of Intravenous Immunoglobulin (IVIg) for Alzheimer's Disease

NCT00299988 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2019-12-11

Study results available
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Summary

The overall goal of this double-blind Phase II study is to evaluate the safety, efficacy and biological mechanisms of action of Intravenous Immunoglobulin (IVIg) in the treatment of mild to moderate stage Alzheimer's disease (AD). IVIg contains antibodies against the amyloid beta protein that is the central component of the AD senile plaque. It is hypothesized that IVIg treatment will reduce the levels of beta amyloid in the brain and improve cognitive abilities relative to placebo. A total of 24 patients with mild to moderate AD capable of giving informed consent will be randomly assigned to receive either IVIg (16 patients)or saline placebo (8 patients) for six months. This study includes comparison of four dosing regimens of IVIg. Cognitive, behavioral and functional measures will be collected at baseline, three months and six months of treatment. Plasma samples will be collected before and after infusions. Subjects will undergo a lumbar puncture before and after the six months of treatment for cerebrospinal fluid (CSF) biomarker analyses. In addition, Positron Emission Tomography (PET) imaging substudies will be performed at two time points during the study. Following the initial 6 month placebo-controlled period, all participants have the opportunity to receive IVIg for an additional 12 month period in an extension study.

Conditions

Interventions

DRUG

Intravenous Immunoglobulin

OTHER

Placebo

Sponsors & Collaborators

  • Baxter BioScience

    collaborator INDUSTRY

  • National Institutes of Health (NIH)

    collaborator NIH

  • Weill Medical College of Cornell University

    lead OTHER

Principal Investigators

  • Norman R Relkin, M.D., Ph.D. · Weill Medical College of Cornell University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-02-28
Primary Completion
2009-01-31
Completion
2010-04-30

Countries

  • United States

Study Locations

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Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00299988 on ClinicalTrials.gov