Clinical Trial

Harmonization of Teleneuropsychological Assessment in Dementia

Completed
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Summary
The prevention and management of cognitive decline and dementia represent major healthcare challenges. Neuropsychological assessment is a key component of current diagnostic criteria for Mild Neurocognitive Disorder (mNCD) due to Alzheimer's disease (AD), supporting both diagnosis and patient follow-up. It enables the evaluation of cognitive domains, monitoring of disease progression, and assessment of treatment effects. Digital tools offer standardized, objective, and scalable methods for cognitive evaluation. The growth of telemedicine and the widespread adoption of digital technologies, accelerated by the COVID-19 pandemic, have increased acceptance of remote healthcare solutions, including teleneuropsychology. Recent advances in mobile technology, together with lower costs and greater accessibility, have facilitated the large-scale implementation of digital cognitive assessments. Tablet-based teleneuropsychological platforms are particularly advantageous for older adults, providing user-friendly interfaces and improving access to care for individuals with mobility limitations or those living in underserved areas. To promote harmonized neuropsychological assessment within the Italian Neuroscience and Neurorehabilitation Network (RIN), this multicenter study aims to establish normative data and clinically validate Tenèpsia®, an innovative tablet-based teleneuropsychological platform certified as a Class IIa Medical Device. The study will support its clinical and research use while evaluating its diagnostic performance in patients with neurocognitive disorders.
Trial Details
NCT Number NCT07664865
Lead Sponsor IRCCS National Neurological Institute "C. Mondino" Foundation
Collaborators: University of Bari Aldo Moro, University of Campania Luigi Vanvitelli, Università degli Studi di Trento, IRCCS Istituto delle Scienze Neurologiche di Bologna, University of Palermo, Asst Degli Spedali Civili Di Brescia, Azienda Usl di Bologna, Istituto Auxologico Italiano
Conditions Cognitive Impairment
Enrollment 250 participants
Start Date 2024-12-01
Primary Completion 2025-07-31 (estimated)
Study Completion 2025-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-06-24