As promised, I want to share some findings presented at the Annual American Academy of Neurology meeting held last week in Toronto, Canada. The is the major meeting for clinical neurologists in this country; it is huge and hectic. And while in recent years there has been a tendency for new data related to Alzheimer’s disease to be presented at conferences devoted entirely to AD (eg, the International Confernece on Alzheimer’s Disease, ICAD), there are always notable reports at AAN.
This year, there was a paper delivered by Dr. Norm Relkin from Cornell on the continuing results from his Phase II trial of pooled human immunoglobulin therapy (called IVIG or sometimes IGIV) for people with AD. For the first time, he was able to describe the results after 18 months of treatment. It is a very small trial, with a total of 24 participants, with 16 initially randomized to receive IGIV and the other eight randomized to receive an identical placebo. After six months of such treatment, all subjects received active IGIV. Of the initial group of 24, 21 are still being followed, 14 from the original active group, and seven from the group that received placebo for six months followed by active treatment.
Norm has reported before that active treatment was associated with better cognitive and clinical results during the six-month placebo controlled phase, and that the benefits persisted even after the placebo group started active treatment. At AAN, he presented data from the 18 month time point, and showed rather dramatic cognitive benefit in the subjects treated with IGIV from the start compared to those starting six months later. Further, he showed that MRI scans revealed a reduction in brain atrophy in those on treatment for the full 18 months.
These results are encouraging, as they are consistent with an important clinical benefit related to this treatment. But caution is necessary. The study is very small indeed. While the findings are statistically significant, they could be influenced by unexpectedly poor performance in the very small group originally on placebo.
But that said, the results do provide further support for the theory that delivery of naturally-occurring anti-amyloid antibodies contained in pooled human immunoglobulin may be an effective therapy for AD. The multicenter Phase III trial under way now, a collaboration between the ADCS and Baxter, could provide a definitive answer.
Thanks for reading,
This post originally appeared in Alzheimer’s Insights, an ADCS Blog.