Synonyms: Intravenous Immunoglobulin, NewGam
Therapy Type: Immunotherapy (passive) (timeline)
Target Type: Amyloid-Related (timeline), Inflammation (timeline)
Condition(s): Alzheimer's Disease, Mild Cognitive Impairment
U.S. FDA Status: Alzheimer's Disease (Phase 2), Mild Cognitive Impairment (Phase 2)
NewGam/Octagam® is an intravenous immunoglobulin preparation by the Switzerland-based company Octapharma. The rationale, as for other intravenous immunoglobulin preparations such as Gammagard® and Flebogamma, is that naturally occurring polyclonal autoantibodies against Aβ may be protective and are reduced in Alzheimer's disease (see Weksler et al., 2002).
The first trial of this IVIG preparation in Alzheimer's evaluated six different doses of Octagam 10 percent against two placebo comparators in a six-month trial of 58 people with mild to moderate AD. This multicenter Phase 2 trial has been completed. This trial missed its primary endpoint of change in plasma Aβ levels, and was negative for most of its secondary biomarker outcomes with the exception of a signal suggesting a benefit for cerebral metabolism. None of the doses tested showed any benefit for cognition or function (see Dodel et al, 2013; Feb 2013 news story).
A second, single-center Phase 2 study conducted at Sutter Institute for Medical Research in Sacramento, California, investigated the effects of this IVIG preparation infused every other week for two months in 52 people with amnestic MCI due to AD, with two years of follow up. Initial results on 28 patients assessed one year after treatment indicated a possible clinical benefit as measured by the Clinical Dementia Rating Sum of Boxes and an effect on brain atrophy as seen on MRI (see American Academy of Neurology 2013 abstract; Mar 2013 conference story).
Clinical Trial Timeline
- Research Brief: Octapharma IVIg Iffy in Phase 2 Trial
- Quick-and-Early IVIG Therapy: Hints of Promise
- Dodel R, Rominger A, Bartenstein P, Barkhof F, Blennow K, Förster S, Winter Y, Bach JP, Popp J, Alferink J, Wiltfang J, Buerger K, Otto M, Antuono P, Jacoby M, Richter R, Stevens J, Melamed I, Goldstein J, Haag S, Wietek S, Farlow M, Jessen F. Intravenous immunoglobulin for treatment of mild-to-moderate Alzheimer's disease: a phase 2, randomised, double-blind, placebo-controlled, dose-finding trial. Lancet Neurol. 2013 Mar;12(3):233-43. Epub 2013 Jan 31 PubMed.
- Weksler ME, Relkin N, Turkenich R, LaRusse S, Zhou L, Szabo P. Patients with Alzheimer disease have lower levels of serum anti-amyloid peptide antibodies than healthy elderly individuals. Exp Gerontol. 2002 Jul;37(7):943-8. PubMed.
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