Abstract Details

Title Initial Findings of a Randomized Double-Blinded Placebo-Controlled Study of Intravenous Immunoglobulin in Mild Cognitive Impairment Due to Alzheimer Disease

Topic Aging and Dementia

Presentation(s) P01 - (-)

Poster/Presentation
Number 013

Objective

Background MCI patients convert to dementia due to Alzheimer Disease (AD) at a rate of approximately15% per year and exhibit significant beta-amyloid (A?) burden. IVIG contains A? antibodies. Recent investigations have shown IVIG to improve cognitive function in AD and slow brain atrophy as measured by ventricular volume with the optimal dosing of 0.4g/kg every 2wks. Retrospective analysis reported standard doses of IVIG for other clinical indications were associated with lower rates of developing AD.

Design/Methods Fifty-one subjects 50 to 84 years of age with MCI by Petersen criteria and NIA-AA criteria were administered 0.4 g/kg 10% Newgam IVIG or 0.9% saline every 2 weeks x 5 doses. APOE status and CSF Alzheimer signature were recorded (lumbar puncture was optional). Cognitive testing (MMSE and CDR-SB) was conducted every 4 months. MRI brain was completed at baseline, 12 months, and 24 months for Neuroquant volumetric analysis.

Results Fifty-one subjects (59% female) with a mean age of 72.4±7.4 years have been enrolled. Forty-three patients completed all infusions with no serious adverse events. Eighteen subjects completed 1-year follow-up. MMSE remained similar: 26.4±2.3 baseline to 25.4±3.9 1-year with IVIG; 26.4±2.6 to 25.8±3.8 with placebo. CDR-SB at 1-year improved with IVIG 1.9±0.9 to 1.8±1.9 and worsened with placebo 1.7±0.9 to 2.4±2.0. MRI ventricular volumetric analysis demonstrated lower brain atrophy with IVIG: mean percent change of 5.2%±3.3% for IVIG and 8.1%±4.2% for placebo.

Conclusions IVIG in subjects with MCI was associated with decreased brain atrophy and improvement of cognitive function on CDR-SB. Affect on conversion rate to AD is yet to be determined. These preliminarily positive but non-statistically significant results indicate that a relatively short course of IVIG in MCI may have disease-modulating effects in AD.

Authors/Disclosures
Shawn Kile, MD PRESENTER	Dr. Kile has nothing to disclose.
William J. Au, MD	No disclosure on file
	No disclosure on file
Renee Low, PhD (Sutter Medical Group)	No disclosure on file
Timothy M. Miller, MD, PhD (Washington University)	Dr. Miller has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Ionis Pharmaceuticals. Dr. Miller has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Dr. Miller has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Arbor Bio. Dr. Miller has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biomarin. The institution of Dr. Miller has received research support from Ionis Pharmaceuticals . Dr. Miller has received intellectual property interests from a discovery or technology relating to health care. Dr. Miller has received intellectual property interests from a discovery or technology relating to health care.

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