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IV Immunoglobulin Fails Alzheimer’s Trial
Additional analyses from a negative phase III clinical trial of intravenous immunoglobulin (IVIG) in people with mild to moderate Alzheimer’s disease (AD) have been reported at the Alzheimer’s Association International Conference 2013 (AAIC 2013) in Boston.
In May 2013, researchers reported that results from the Gammaglobulin Alzheimer’s Partnership (GAP) study were negative on the main outcome measures, which were two well-established tests of cognition and daily functioning — the ADAS-Cog and ADCS-ADL. At the same time, they reported favorable cognitive changes in two pre-specified subgroups: people with AD who carried the APOE-e4 AD risk gene and those who were moderately impaired.
At AAIC 2013, lead investigator Norman Relkin, MD, PhD, reported on additional analyses, including cognitive and biomarker tests. For cognition, the researchers found that study participants in the APOE-e4 carrier subgroup receiving IVIG 400 mg/kg every 2 weeks (n = 87) had numerically superior results at 18 months compared with participants given placebo on the Modified Mini-Mental State (3MS) examination (n = 66) and on the Trails B test (n = 77), two out of several measures of thinking ability made in the study.
“It is important to say that the GAP study results do not provide grounds for prescribing IVIG in Alzheimer's disease. Even with this positive signal in the APOE-e4 carriers, further confirmatory studies would be needed before clinical use could be recommended,” Relkin said.
Source: AAIC; July 16, 2013.