Phase II Study of Intravenous Immunoglobulin (IVIg) for Alzheimer's Disease
Status:
Terminated
Trial end date:
2010-04-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Weill Medical College of Cornell University
Collaborators:
Baxter BioScience National Institutes of Health (NIH)