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

<i>N</i>-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 e...

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Bibliographic Details
Main Authors: Michela Bossa, Ornella Argento, Chiara Piacentini, Nicola Manocchio, Lucia Scipioni, Sergio Oddi, Mauro Maccarrone, Ugo Nocentini
Format: Article
Language:English
Published: MDPI AG 2023-07-01
Series:Brain Sciences
Subjects:
Online Access:https://www.mdpi.com/2076-3425/13/8/1138
Description
Summary:<i>N</i>-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.
ISSN:2076-3425