drugset / Trial / NCT01300728

Study of Intravenous Immunoglobulin in Amnestic Mild Cognitive Impairment

NCT01300728 ↗

Phase 2 Completed 52 enrolled Sutter Health
RandomizedParallel-groupTriple-blindTreatment

Summary

Patients with mild cognitive impairment (MCI) are a group recognized at being at high risk of progressing to Alzheimer disease. Treatment of MCI with immunotherapy with intravenous immunoglobulins (IVIG) could potentially reduce the risk of progression to Alzheimer disease. This study will evaluate the efficacy of intravenous immunoglobulin in patients with MCI over 24 months after the first infusion. This study will also document conversion from MCI to Alzheimer's Disease.

Timeline

Start
2011-01-01
Primary completion
2020-03-12
Completion
2020-03-12

Outcome

Missed primary endpoint

paper Differences in brain atrophy between the groups, which were statistically significant after one year, were no longer significant after five years. PMID 34362303 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Immune Globulin Intravenous (Human) Protein / enzyme biologic 0.4 g/kg Intravenous