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Posted by on May 7, 2013 in Neurology, Pharma

IV Ig a Bust in Alzheimer’s

IV Ig a Bust in Alzheimer’s

Thumbs_down.jpgPossibly the last immunotherapy hope in established Alzheimer disease, intravenous gamma globulin (aka IV Ig) failed to slow cognitive decline in a large, closely watched phase 3 trial. According to today’s press release from Baxter, the trial sponsor, IV Ig* did not significantly alter cognitive decline or preserve functional abilities over 18 months, when compared with placebo, in patients with mild-moderate AD (total N = 390). Baxter provides a very handy data table here of the topline results.

Like other commercial investigators of AD, however, Baxter remains interested in assessing outcomes of subgroups. Notably there was a numerically greater difference in cognitive decline between some patients** who received high-dose IV Ig and placebo-treated enrollees. But the phase 3 study was not statistically powered to validate these post-hoc analyses.

Generally IV Ig was well tolerated in the study with no new adverse-event signals. The most common side effects (in at least 5% of subjects) were rash and falls in hemoglobin levels. A total of 12 IV Ig-treated patients and 5 placebo-treated patients reportedly experienced serious adverse events.

According to Baxter, its studies of IV Ig in mild-moderate AD will be discontinued. The full study results will be presented at the AAIC in July.

* At doses of either 200 or 400 mg/kg every 2 weeks.
** Specifically those with moderate disease or ApoE4 carriers.

bmartin (1127 Posts)

A native East Tennessean, Barbara Martin is a formerly practicing, board-certified neurologist who received her BS (psychology, summa cum laude) and MD from Duke University before completing her postgraduate training (internship, residency, fellowship) at the Hospital of the University of Pennsylvania in Philadelphia. She has worked in academia, private practice, medical publishing, drug market research, and continuing medical education (CME). For the last 3 years, she has worked in a freelance capacity as a medical writer, analyst, and consultant. Follow Dr. Barbara Martin on and Twitter.