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Completed
NCT07664865
Harmonization of Teleneuropsychological Assessment in Dementia
Conditions: Cognitive Impairment
Sex: All
Ages: 40 Years – 89 Years
Healthy volunteers: Yes
Enrollment: 250
Sponsor: IRCCS National Neurological Institute "C. Mondino" Foundation
Location: Unit of Research in Cognitive Psychology Pavia
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.
Eligibility Criteria
Criteria of Healthy subjects:
* Inclusion: age between 40 and 89 years; Montreal Cognitive Assessment (MoCA) adjusted score greater than or equal to 23;
* Exclusion: sensory deficits (e.g., hypovision, hearing loss) and/or reported chronic pain potentially affecting teleneuropsychological performance; chronic treatment with psychotropic drugs and/or potentially interfering with cognitive functions in the opinion of the recruiting physician.
Criteria of Pathological subjects:
* Inclusion: age between 40 and 89 years; diagnosis of mNCD according to the DMS-5;
* Exclusion: pathological subjects: sensory deficits (e.g., hypovision, hearing loss) and/or reported chronic pain potentially affecting teleneuropsychological performance; chronic treatment with psychotropic drugs and/or potentially interfering with cognitive functions in the opinion of the recruiting physician; history of cerebrovascular disease, head trauma, or brain tumor; alcoholism; severe internal medicine pathologies associated with cognitive deficit (e.g., organ failure, endocrine pathologies, particularly thyroid and B12/folate deficiency).
Source: ClinicalTrials.gov (NCT07664865). StuddyBuddy aggregates publicly available trial information.