Harmonization of Teleneuropsychological Assessment in Dementia

NCT07664865 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 250

Last updated 2026-06-24

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

  • University of Bari Aldo Moro

    collaborator OTHER
  • University of Campania Luigi Vanvitelli

    collaborator OTHER
  • Università degli Studi di Trento

    collaborator OTHER
  • IRCCS Istituto delle Scienze Neurologiche di Bologna

    collaborator OTHER
  • University of Palermo

    collaborator OTHER
  • Asst Degli Spedali Civili Di Brescia

    collaborator OTHER
  • Azienda Usl di Bologna

    collaborator OTHER_GOV
  • Istituto Auxologico Italiano

    collaborator OTHER
  • IRCCS National Neurological Institute "C. Mondino" Foundation

    lead OTHER

Principal Investigators

  • Sara Bottiroli, PhD · Unit of Research in Cognitive Psycology

Eligibility

Min Age
40 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-12-01
Primary Completion
2025-07-31
Completion
2025-12-31

Countries

  • Italy

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07664865 on ClinicalTrials.gov