Harmonization of Teleneuropsychological Assessment in Dementia

Digitalization of Procedures for Neuropsychological Assessment for Neurocognitive Disorders: Standardization and Clinical Validation of the Teleneuropsychology Platform Tenèpsia®

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.

The prevention and management of cognitive decline and dementia represent one of the major healthcare challenges of our time. Neuropsychological assessment, which is included in all current diagnostic criteria, represents a key step in the diagnostic pathway of patients with Mild Cognitive Impairment (MCI) due to Alzheimer's disease (AD). Recent European intersocietal consensus guidelines have identified neuropsychological assessment as appropriate immediately after clinical screening, when the specialist formulates the suspicion of cognitive impairment and initiates the diagnostic process. At this stage, the assessment of the main cognitive domains is recommended, usually through standardized tests with normative values for the reference population. Beyond the diagnostic phase, neuropsychological assessment plays a crucial role in the clinical follow-up of patients, both to monitor disease progression and to measure the potential effects of pharmacological and non-pharmacological treatments.

Digital tools able to assess patients through standardized, objective, and efficient methods on a large scale may have great clinical and research value. As shown by several experiences in Italy and abroad, telemedicine has emerged as a valid approach to provide remote care to patients with chronic conditions, helping to prevent the negative consequences of delayed diagnosis and interruption of care. The increased use of digital technologies for daily activities during the COVID-19 pandemic, including work, education, entertainment, and access to information, has improved familiarity with mobile digital devices and promoted greater acceptability of digital healthcare solutions, including among older adults. In this context, teleneuropsychology represents a highly promising area of innovation within telemedicine.

The most advanced approach in teleneuropsychology is the development of comprehensive neuropsychological batteries implemented in digital platforms for web-based assessment. Although this field has undergone substantial development over recent decades, the application of digital tools in clinical practice remains relatively limited. For many years, high costs and the limited use of digital devices among older adults restricted their implementation. More recently, major advances in mobile technology, together with lower costs and wider availability of digital devices, have paved the way for the large-scale application of teleneuropsychology.

Tablet-based teleneuropsychological platforms may improve and accelerate the diagnostic and patient management process, especially for individuals with comorbidities or motor disabilities and for those living in rural areas with limited healthcare resources. Moreover, tablets may be more efficient and accessible for older adults with cognitive decline or dementia, due to their practical and user-friendly interfaces compared with computers or smartphones.

The harmonization of neuropsychological assessment procedures in dementing disorders is essential for the development of shared clinical and research activities within the Italian Network of Neuroscience and Neurorehabilitation IRCCS Institutes (RIN). In this framework, the present multicenter study aims to collect normative data and clinically validate, in patients with neurocognitive disorders, an innovative tablet-based teleneuropsychological platform, Tenèpsia®. Tenèpsia® is already certified as a Class IIa Medical Device according to Medical Device Regulation 745/2017 for clinical use in support of neuropsychological diagnosis in patients with suspected neurocognitive disorders. Therefore, the present project does not aim to validate the device as a medical device, but rather to collect Italian normative data and evaluate its clinical performance in the context of neurocognitive disorders.

The general objective of the project is twofold: first, to collect normative data for the Italian population through the administration of the Tenèpsia® battery to a sample of healthy adults; second, to clinically validate the platform in patients with mild neurocognitive disorder, in order to promote its use in both clinical and research settings.

The primary objectives are: 1) to collect normative data through the administration of the tablet-based battery to healthy participants in a single session lasting approximately 45 minutes; and 2) to evaluate the ability of the Tenèpsia® platform to detect significant differences between patients with mild neurocognitive disorder and healthy controls.

The secondary objectives are: 1) to assess the association between scores obtained in the different tests included in the Tenèpsia® battery, separately in patients and controls; 3) to evaluate the contribution of each test of the Tenèpsia® battery in discriminating between patients and healthy controls; and 4) to assess the usability and user experience of the Tenèpsia® platform in both healthy participants and patients through validated questionnaires and scales.

This is a multicenter, proposer-coordinated, observational, transversal study. Both healthy adult volunteers and patients with a diagnosis of mild neurocognitive disorder, both males and females, are recruited at IRCCS Mondino Foundation in Pavia and at the other participating satellite centers.

Healthy participants are eligible if they are aged between 40 and 89 years and have a Montreal Cognitive Assessment (MoCA) score equal to or greater than 23, corrected for age and education. Patients are eligible if they are aged between 40 and 89 years and have a diagnosis of mild neurocognitive disorder according to DSM-5 criteria. Exclusion criteria for healthy participants include sensory deficits, such as visual or hearing impairment, and/or chronic pain potentially affecting teleneuropsychological performance, as well as chronic treatment with psychotropic drugs or other medications potentially interfering with cognitive functions, according to the recruiting physician's judgement. For patients, exclusion criteria include sensory deficits and/or chronic pain potentially affecting teleneuropsychological performance; chronic treatment with psychotropic drugs or other medications potentially interfering with cognitive functions; history of cerebrovascular disease, traumatic brain injury, or brain neoplasm; alcoholism; and severe systemic diseases associated with cognitive impairment, such as organ failure, endocrine disorders, particularly thyroid disease, or vitamin B12/folate deficiency.

The overall study duration is 12 months, with a recruitment period of 10 months. All participants are evaluated according to the inclusion and exclusion criteria, and written informed consent is collected. For each participant, demographic information, including age, education, and sex, is recorded. A global cognitive assessment is performed in person using the MoCA. Trained expert examiners then carry out the teleneuropsychological assessment with the Tenèpsia® platform remotely.

All participants complete the Tenèpsia® teleneuropsychological battery through a dedicated tablet application. The battery includes tests designed to assess the main cognitive domains, namely memory, attention, language, executive functions, and visuospatial abilities. Specifically, the battery includes the Free and Cued Selective Reminding Test (FCSRT), spatial supraspan, copy and delayed recall of the Rey-Osterrieth Complex Figure, phonemic and semantic verbal fluency, complex figure description, naming test, pentagon copy, clock drawing test, symbol digit test, Stroop test, and emotion recognition test. The total administration time of the battery is approximately 45 minutes.

At the end of the assessment, participants complete questionnaires aimed at evaluating usability and user experience of the platform. These include the System Usability Scale, the Post-Study System Usability Scale, the Telehealth Questionnaire, the User Experience Questionnaire, and the IT Familiarity Questionnaire. Completion of these questionnaires takes approximately 5-8 minutes.

Overall, this study is expected to provide normative data for the Italian population and to explore the clinical utility, diagnostic performance, usability, and acceptability of the Tenèpsia® platform in both healthy adults and patients with mild neurocognitive disorder. The results may support the integration of tablet-based teleneuropsychology into clinical and research pathways, contributing to more accessible, standardized, and harmonized neuropsychological assessment procedures across participating centers.

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).