Abstract

AbstractBackgroundAs the prevalence of Alzheimer’s disease (AD) continues to rise, alternative approaches are sought to have a greater understanding of this neurological disease. One approach of interest would be to identify individuals who are at risk of Alzheimer’s disease (AD) and determine the efficacy of a selected therapeutic. Persons with Mild Cognitive Impairment (MCI) are at risk of incident dementia, and being coupled with deficits in short‐term recall, significantly increases their risk of incident AD. In addition, having risk factors of the metabolic syndrome, such as prediabetes, has also been found to augment the risk of incident cognitive impairment. This is further strengthened by evidence showing neurons in AD brains being insulin resistant. Previous animal studies have found that a nutraceutical containing grape seed polyphenol extract (GSPE) and resveratrol to be associated with improved cognition and lowering brain amyloid and tau burden. The current clinical study is being taken as a first step to investigate the safety and tolerability of GSPE and resveratrol in patients who have Mild Cognitive Impairment (MCI) and diabetes. In addition, this study will also quantify the bioavailability of selected polyphenols and their metabolites, and determine if any changes are seen between the treatment and placebo group at the end of the study in regards to cognitive test scores, and CSF content of tau/β‐amyloid 42.MethodParticipants were entered into a 4 month double‐blinded study and given either a placebo, or a mixture containing 450 mg of GSPE and 125 mg of resveratrol. Serum samples were taken at baseline, 2 months, and 4 months, whereas CSF samples were taken at the start and end of the study.ResultThe study is still ongoing and additional individuals are enrolling in the study. No adverse events related to GSPE and resveratrol have been observed from the participants to date, and compliance has been good.ConclusionAt the conclusion of this clinical trial, in addition to determining the safety and tolerability of GSPE and resveratrol, a greater understanding will be attained as to the potential association of selected polyphenol metabolites and biomarkers of AD neuropathology in CSF.

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