Joseph Michael Palumbo, MD, BioVie Inc., Carson City, NV, describes the study conducted to investigate the effect of NE3107 in patients with mild cognitive impairment (MCI) and mild dementia. The study (NCT05227820) was an open-label extension looking at 25 patients over 3 months with dosing twice daily by oral route. Over the three months, they investigated typical neuropsychological and neuropsychiatric batteries (Cog12), CSF and blood biomarkers, and neuroimaging. The ADAS-Cog improved from baseline, accompanied by improvements in inflammatory biomarkers and functional connectivity activity in brain scans. The expected effects on glutathione (measured with MRS in the brain) occurred with the levels improving and correlating with both functional and biological improvement. The clinical work found multiple positive findings in a short study, and the multi-modal correlation studies supported these by showing that they nicely correlated with improvements in functional connectivity activity, a reduction in the burden of inflammatory cytokines, and reduced TNF-alpha. For the future, Dr. Palumbo is looking at studying this in mild to moderate dementia in the US, recruiting 400 patients, and expecting a readout at the end of the year. They are also looking into starting programs for Parkinson’s disease and MCI. This interview took place at the AAN Annual Meeting 2023 in Boston, MA.
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Dr Palumbo is a full-time employee of BioVie, Inc.