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STUDY PROTOCOL article

Front. Neurol.
Sec. Dementia and Neurodegenerative Diseases
Volume 15 - 2024 | doi: 10.3389/fneur.2024.1434210
This article is part of the Research Topic Neuropsychiatric symptoms and cognitive impairment View all 13 articles

FORTCARE-MCI Study Protocol: Evaluation of Fortasyn Connect in the Management of Mild Cognitive Impairment in Primary Care

Provisionally accepted
Enrique Arrieta Enrique Arrieta 1Pablo Baz Pablo Baz 2*Guillermo Garcia-Ribas Guillermo Garcia-Ribas 3
  • 1 Segovia Rural Health Center, Neurology Working Group of SERMERGEN, Spain, Segovia, Spain
  • 2 North Periurban Health Center of Salamanca, Neurology Working Group of SERMERGEN, Spain, Salamanca, Spain
  • 3 Ramón y Cajal University Hospital, Madrid, Madrid, Spain

The final, formatted version of the article will be published soon.

    Background: Neuropsychiatric symptoms are prevalent in patients with mild cognitive impairment (MCI) and are predictive of the conversion to dementia. Fortasyn Connect, a medical food, has shown efficacy in managing cognitive and behavioral symptoms associated with MCI. Early diagnosis and intervention in primary care are essential for managing MCI. However, real-world prospective studies assessing Fortasyn Connect in MCI are still limited.Methods: This observational, multicenter, prospective study will enroll 150 patients recently diagnosed with MCI by primary care physicians across several regions in Spain. Participants will be followed-up over a 12-month period, with assessments at baseline, 6 months, and 12 months, as per clinical practice. The study aims to evaluate the impact of Fortasyn Connect on neuropsychiatric symptoms, cognition, and health-related quality of life (HRQoL) using validated neuropsychological tests and machine learning (ML) techniques. The primary outcome measure will be changes in neuropsychiatric symptoms using the Neuropsychiatric Inventory Questionnaire (NPI-Q) at 6 months. Secondary outcome measures include further changes in the NPI-Q at 12 months, and changes in cognition (Fototest, and clock-drawing test) and HRQoL (EQ-5D-5L) at 6 and 12 months. Exploratory outcomes will assess speech using an artificial intelligence (AI)-enhanced ML tool, with a correlation analysis of these findings with traditional neuropsychological test results.This study will provide evidence of the effectiveness of Fortasyn Connect in a realworld setting, exploring its potential to stabilize or improve neuropsychiatric symptoms, cognition, and HRQoL in MCI patients. Results will also contribute to the understanding of AI and ML in identifying early biomarkers of cognitive decline, supporting the timely management of MCI.

    Keywords: Mild Cognitive Impairment, Primary Care, Treatment, Fortasyn connect, Alzheimer's disease

    Received: 17 May 2024; Accepted: 11 Sep 2024.

    Copyright: © 2024 Arrieta, Baz and Garcia-Ribas. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence: Pablo Baz, North Periurban Health Center of Salamanca, Neurology Working Group of SERMERGEN, Spain, Salamanca, Spain

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.