A Nutritional Formulation for Cognitive Performance in Mild Cognitive Impairment: A Placebo-Controlled Trial with an Open-Label Extension.

Ruth Remington, Jevin J Lortie, Heather Hoffmann, Robert Page, Christopher Morrell, Thomas B Shea

Journal: Journal of Alzheimer's disease : JAD 2016;48(3):591-5

PMID: 26402075

Plain Language Summary

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Mild cognitive impairment (MCI) is characterised by cognitive decline beyond that of normal age-related decline. A nutraceutical formulation (NF) has been shown to improve cognitive performance among individuals diagnosed with Alzheimer disease. The aim of this study was to evaluate the efficacy of a specific NF in improving overall cognitive performance among 34 individuals diagnosed with MCI. Participants were randomised to receive the NF tablet or placebo tablet daily for six months, followed by a six-month open-label extension in which all participants received the NF. The intervention cohort improved in the Dementia Rating Scale (DRS), and during the open-label extension, the placebo cohort improved DRS. These findings extend the existing findings and demonstrate the beneficial effect of NF supplementation for delaying or minimising cognitive decline for individuals with MCI.

Abstract

Thirty-four individuals with mild cognitive impairment were randomized for 6 months to a nutraceutical formulation (NF: folate, alpha-tocopherol, B12, S-adenosyl methioinine, N-acetyl cysteine, acetyl-L-carnitine) or indistinguishable placebo, followed by a 6-month open-label extension in which all individuals received NF. The NF cohort improved in the Dementia Rating Scale (DRS; effect size >0.7) and maintained baseline performance in CLOX-1. The placebo cohort did not improve in DRS and declined in CLOX-1, but during the open-label extension improved in DRS and ceased declining in CLOX-1. These findings extend prior studies of NF efficacy for individuals without cognitive impairment and with Alzheimer's disease.

Address: Framingham State University, Framingham, MA, USA.; Knox College, Galesburg, IL, USA.; Loyola University Maryland, Baltimore, MD, USA.; University of Massachusetts Lowell, Lowell, MA, USA.
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