Effects of Long-Term Oral Administration of N-Palmitoylethanolamine in Subjects with Mild Cognitive Impairment: Study Protocol

长期口服 N-棕榈酰乙醇胺对轻度认知障碍患者的影响:研究方案

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作者:Michela Bossa, Ornella Argento, Chiara Piacentini, Nicola Manocchio, Lucia Scipioni, Sergio Oddi, Mauro Maccarrone, Ugo Nocentini

Abstract

N-palmitoylethanolamine (PEA) plays a key role in preventing Aβ-mediated neuroinflammation and neurotoxicity in murine models. It has been demonstrated that PEA provides anti-neuroinflammatory, pain-relieving and neuroprotective actions even in humans. In this project, we aim to evaluate these anti-neuroinflammatory effects via the cognitive evaluation and biochemical analyses of a 12-month oral administration of PEA in subjects with mild cognitive impairment (MCI). Subjects with MCI will be randomized to placebo or PEA groups, and followed for another 6 months. Cognitive abilities and neurological inflammation will be examined at baseline and after treatment. The specific objectives of the project are to ascertain whether: (i) PEA influences the scores of the neuropsychological and behavioral evaluations after one-year treatment, comparing PEA-treated and placebo subjects in both MCI and control groups; (ii) PEA can change the inflammatory and neuronal damage markers of blood and urine in MCI subjects; and (iii) these changes correlate with the clinical scores of participating subjects.

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