Safety and tolerability of immune globulin intravenous (human), 10% solution in Japanese subjects with mild to moderate Alzheimer's disease

Abstract

IGIV is generally safe and well tolerated with multiple intravenous infusions at doses of 0.2 g/kg and 0.4 g/kg in Japanese patients with mild to moderate Alzheimer's disease.

Intravenous Immunoglobulin for Patients With Alzheimer’s Disease: A Systematic Review and Meta-Analysis

“…We did not evaluate risk of bias for one study because it did not assess the primary outcome. 35 Overall, two studies were at low risk of bias. 36,37 One study was deemed at high risk of bias due to early termination, 40 while the remaining one was deemed as having some concerns due to missing outcome data.…”

“…Twelve records describing six trials (788 patients) were included in the systematic review. [35][36][37][38][39][40] Results for one trial were available solely from conference abstracts and were not reported in a way that could be used in a meta-analysis. 38 Data were requested from the corresponding author, 41 but were not made available; hence, this study was reviewed but could not be incorporated in the meta-analysis.…”

“…Five trials recruited patients with a diagnosis of probable mild-tomoderate dementia due to AD established according to the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria. 35,36,[38][39][40]42 The remaining trial recruited patients with single or multidomain amnestic MCI due to AD. 37 IVIg was administered for a time period of 8 to 70 weeks, while the mean number of infusions per participant ranged from 5 to 29.9.…”

“…40 Three trials assessed both regimens of 0.2 and 0.4 g/kg q2wk. 35,39,40 One trial utilized only the regimen of 0.4 g/kg q2wk, 37 while the two remaining studies assessed multiple dosing schemes. 36,38 Of note, for one of these trials apart from the 0.4 g/kg q2wk treatment arm, we also extracted data for the dosing regimen of 0.25 g/kg q2wk, since this was the closest to our predetermined regimen of 0.2 g/kg q2wk.…”

Neuroactive compounds obtained from arthropod venoms as new therapeutic platforms for the treatment of neurological disorders

“…Another approach aimed at treating symptoms in patients with mild-to-moderate AD include the use of immune globulin intravenous (IGIV 10 %), a biologic agent containing human immunoglobulin IgG antibodies with anti-inflammatory and immunomodulating properties. IGIV binds to oligomeric and amyloid-β fibrils to reverse neurotoxic events in clinical and preclinical settings [ 43 ].…”