Cognitive ImpairmentNCT07664865
Harmonization of Teleneuropsychological Assessment in Dementia
An observational study of Cognitive Impairment, run by IRCCS National Neurological Institute "C. Mondino" Foundation at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Impairment
- How many people
- 250 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2024to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 200 healthy subjects and 50 patients with a diagnosis of Mild Neurocognitive Disorder (mNCD), equally distributed between the collaborating 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Cognitive Impairment
- Keywords
- teleneuropsychology, cognitive disorders, digitalization, remote assessment, dementia, neurodegenerative disorders
- Medical subject headings
- Cognitive Dysfunction, Dementia, Neurodegenerative Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 200 healthy subjects | equally distributed between the collaborating centers | |
| 50 patients | equally distributed between the collaborating centers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collecting normative data
Administration of the tablet-based battery to a sample of healthy subjects in a single session lasting approximately 45/60 minutes (Phase 1 objective)
Measured: At baseline
Free and Cued Selective Reminding Test (FCSRT)
Verbal episodic memory assessed by the FCSRT. The digital version includes 16 words presented in four sets of four items. Free recall scores range from 0 to 48 and total recall scores range from 0 to 48. Higher scores indicate better verbal leraning and memory performance.
Measured: At baseline
Spatial Supraspan
Visuospatial working memory assessed by the Spatial Supraspan test. Participants are required to reproduce increasingly longer spatial sequences presented on the tablet. Higher scores indicate better visuospatial memory performance.
Measured: At baseline
Rey-Osterrieth Complex Figure Delayed Recall
Visual episodic memory assessed by the Rey-Osterrieth Complex Figure delayed recall task. Scores range from 0 to 36. Higher scores indicate better visual memory performance.
Measured: At baseline
Phonemic and Semantic Verbal Fluency
Language and executive functioning assessed through phonemic and semantic verbal fluency tasks. Participants are required to generate words belonging to a semantic category or beginning with a target letter within a fixed time interval. The score corresponds to the number of correct words produced. Higher scores indicate better language and executive functioning.
Measured: At baseline
Complex Picture Description Test
Spontaneous speech production assessed using the complex picture description task from the Screening of Aphasia in NeuroDegeneration (SAND) battery. The score is based on the number of nouns, verbs and complete sentences produced. Higher scores indicate better language production abilities.
Measured: At baseline
Picture Naming Test
Lexical-semantic abilities assessed by a picture naming task including 16 coloured living and non-living objects. Scores range from 0 to 16. Higher scores indicate better naming performance and lexical retrieval abilities.
Measured: At baseline
Rey-Osterrieth Complex Figure Copy
Visuoconstructional abilities assessed by the Rey-Osterrieth Complex Figure copy task. Scores range from 0 to 36. Higher scores indicate better visuospatial and constructional abilities.
Measured: At baseline
Pentagon Copying Test
Visuoconstructional abilities assessed through copying intersecting pentagons. Higher scores indicate better visuospatial and constructional performance.
Measured: At baseline
Clock Drawing Test
Visuospatial and executive functioning assessed by the Clock Drawing Test. Higher scores indicate better visuoconstructional and executive abilities.
Measured: At baseline
Symbol Digit Modalities Test (SDMT)
Attention, processing speed and executive functioning assessed by the SDMT. The score corresponds to the number of correct symbol-digit associations completed within the allotted time. Higher scores indicate better cognitive processing speed and attention.
Measured: At baseline
Stroop Test
Executive functioning and inhibitory control assessed by the Stroop Test. Scores are based on response accuracy and interference effects across test conditions. Better performance is reflected by fewer errors and lower interference.
Measured: At baseline
Emotion Recognition Test
Social cognition assessed by the Emotion Recognition Test. The digital version includes 28 facial stimuli depicting basic emotions and neutral expressions. Scores range from 0 to 28. Higher scores indicate better recognition of facial emotions and social cognitive functioning.
Measured: At baseline
Geriatric Depression Scale (GDS-15)
Depressive symptoms assessed by the 15-item GDS. Scores range from 0 to 15. Higher scores indicate more severe depressive symptoms. A score of 5 or greater suggests clinically relevant depressive symptoms.
Measured: At baseline
Activities of Daily Living (ADL)
Basic functional independence assessed by the ADL scale. Scores range from 0 to 6. Higher scores indicate greater independence in daily functioning.
Measured: At baseline
Instrumental Activities of Daily Living (IADL)
Functional independence in complex daily activities assessed by the IADL scale. Scores range from 0 to 8. Higher scores indicate greater functional independence.
Measured: At baseline
Secondary outcomes (5)
Learning and Memory: FCSRT, Spatial Supraspan, Rey-Osterrieth Complex Figure Delayed Recall.
Scores obtained on the FCSRT, Spatial Supraspan, and Rey-Osterrieth Complex Figure Delayed Recall, which assess learning and memory abilities. Correlations between test scores will be examined separately in healthy controls and patients.
Measured: At baseline
Language: Picture Naming Test, Phonemic and Semantic Verbal Fluency, Complex Picture Description Test.
Scores obtained on the Picture Naming test, Phonemic and Semantic Verbal Fluency, and Complex Picture Description Test, which assess language abilities. Correlations between test scores will be examined separately in healthy controls and patients.
Measured: At baseline
Visuo-perceptual and Constructional Skills: Rey-Osterrieth Complex Figure Copy, Pentagon Copying Test, Clock Drawing Test.
Scores obtained on the Rey-Osterrieth Complex Figure Copy, Pentagon Copying Test, and Clock Drawing Test, which assess visuoperceptual and constructional abilities. Correlations between test scores will be examined separately in healthy controls and patients.
Measured: At baseline
Attention and Executive Functions: SDMT, Stroop Test.
Scores obtained on the SDMT and Stroop Test, which assess attention, processing speed, inhibitory control, and executive functioning. Correlations between test scores will be examined separately in healthy controls and patients.
Measured: At baseline
Evaluation of the usability and user-experience
Administration of validated questionnaires and scales to both healthy subjects and patients.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start1 Dec 2024
- Primary completion31 Jul 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS National Neurological Institute "C. Mondino" Foundation
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Sara Bottiroli, PhD, Principal investigator, Unit of Research in Cognitive Psycology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07664865
- Sponsor's protocol ID
- Tenepsia
- Status last verified
- Jun 2026
- First submitted
- 11 Jun 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bosco A, Spano G, Caffo AO, Lopez A, Grattagliano I, Saracino G, Pinto K, Hoogeveen F, Lancioni GE. Italians do it worse. Montreal Cognitive Assessment (MoCA) optimal cut-off scores for people with probable Alzheimer's disease and with probable cognitive impairment. Aging Clin Exp Res. 2017 Dec;29(6):1113-1120. doi: 10.1007/s40520-017-0727-6. Epub 2017 Feb 2.
PubMed 28155182Conca F, Esposito V, Rundo F, Quaranta D, Muscio C, Manenti R, Caruso G, Lucca U, Galbussera AA, Di Tella S, Baglio F, L'Abbate F, Canu E, Catania V, Filippi M, Mattavelli G, Poletti B, Silani V, Lodi R, De Matteis M, Stanzani Maserati M, Arighi A, Rotondo E, Tanzilli A, Pace A, Garramone F, Cavaliere C, Pardini M, Rizzetto C, Sorbi S, Perri R, Tiraboschi P, Canessa N, Cotelli M, Ferri R, Weintraub S, Marra C, Tagliavini F, Catricala E, Cappa SF. Italian adaptation of the Uniform Data Set Neuropsychological Test Battery (I-UDSNB 1.0): development and normative data. Alzheimers Res Ther. 2022 Aug 19;14(1):113. doi: 10.1186/s13195-022-01056-x.
PubMed 35982477Stasenko A, Jacobs DM, Salmon DP, Gollan TH. The Multilingual Naming Test (MINT) as a Measure of Picture Naming Ability in Alzheimer's Disease. J Int Neuropsychol Soc. 2019 Sep;25(8):821-833. doi: 10.1017/S1355617719000560. Epub 2019 Jun 28.
PubMed 31248465Staffaroni AM, Tsoy E, Taylor J, Boxer AL, Possin KL. Digital Cognitive Assessments for Dementia: Digital assessments may enhance the efficiency of evaluations in neurology and other clinics. Pract Neurol (Fort Wash Pa). 2020 Nov-Dec;2020:24-45. No abstract available.
PubMed 33927583Bauer RM, Iverson GL, Cernich AN, Binder LM, Ruff RM, Naugle RI. Computerized neuropsychological assessment devices: joint position paper of the American Academy of Clinical Neuropsychology and the National Academy of Neuropsychology. Arch Clin Neuropsychol. 2012 May;27(3):362-73. doi: 10.1093/arclin/acs027. Epub 2012 Mar 1.
PubMed 22382386Hammers DB, Stolwyk R, Harder L, Cullum CM. A survey of international clinical teleneuropsychology service provision prior to and in the context of COVID-19. Clin Neuropsychol. 2020 Oct-Nov;34(7-8):1267-1283. doi: 10.1080/13854046.2020.1810323. Epub 2020 Aug 26.
PubMed 32844714Bilder RM, Postal KS, Barisa M, Aase DM, Cullum CM, Gillaspy SR, Harder L, Kanter G, Lanca M, Lechuga DM, Morgan JM, Most R, Puente AE, Salinas CM, Woodhouse J. Inter Organizational Practice Committee Recommendations/Guidance for Teleneuropsychology in Response to the COVID-19 Pandemicdagger. Arch Clin Neuropsychol. 2020 Aug 28;35(6):647-659. doi: 10.1093/arclin/acaa046.
PubMed 32666093Marra DE, Hamlet KM, Bauer RM, Bowers D. Validity of teleneuropsychology for older adults in response to COVID-19: A systematic and critical review. Clin Neuropsychol. 2020 Oct-Nov;34(7-8):1411-1452. doi: 10.1080/13854046.2020.1769192. Epub 2020 Jun 10.
PubMed 32519594Gareev I, Gallyametdinov A, Beylerli O, Valitov E, Alyshov A, Pavlov V, Izmailov A, Zhao S. The opportunities and challenges of telemedicine during COVID-19 pandemic. Front Biosci (Elite Ed). 2021 Dec 20;13(2):291-298. doi: 10.52586/E885.
PubMed 34937315Colbert GB, Venegas-Vera AV, Lerma EV. Utility of telemedicine in the COVID-19 era. Rev Cardiovasc Med. 2020 Dec 30;21(4):583-587. doi: 10.31083/j.rcm.2020.04.188.
PubMed 33388003Lukas H, Xu C, Yu Y, Gao W. Emerging Telemedicine Tools for Remote COVID-19 Diagnosis, Monitoring, and Management. ACS Nano. 2020 Dec 22;14(12):16180-16193. doi: 10.1021/acsnano.0c08494. Epub 2020 Dec 14.
PubMed 33314910Hincapie MA, Gallego JC, Gempeler A, Pineros JA, Nasner D, Escobar MF. Implementation and Usefulness of Telemedicine During the COVID-19 Pandemic: A Scoping Review. J Prim Care Community Health. 2020 Jan-Dec;11:2150132720980612. doi: 10.1177/2150132720980612.
PubMed 33300414Bernini S, Panzarasa S, Quaglini S, Costa A, Picascia M, Cappa SF, Cerami C, Tassorelli C, Vecchi T, Bottiroli S. HomeCoRe system for telerehabilitation in individuals at risk of dementia: A usability and user experience study. Front Med (Lausanne). 2023 Feb 17;10:1129914. doi: 10.3389/fmed.2023.1129914. eCollection 2023.
PubMed 36873886van der Walt A, Butzkueven H, Shin RK, Midaglia L, Capezzuto L, Lindemann M, Davies G, Butler LM, Costantino C, Montalban X. Developing a Digital Solution for Remote Assessment in Multiple Sclerosis: From Concept to Software as a Medical Device. Brain Sci. 2021 Sep 21;11(9):1247. doi: 10.3390/brainsci11091247.
PubMed 34573267Moccia M, Lanzillo R, Brescia Morra V, Bonavita S, Tedeschi G, Leocani L, Lavorgna L; Digital Technologies Web and Social Media Study Group of the Italian Society of Neurology. Assessing disability and relapses in multiple sclerosis on tele-neurology. Neurol Sci. 2020 Jun;41(6):1369-1371. doi: 10.1007/s10072-020-04470-x. Epub 2020 May 21.
PubMed 32440979
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digitalization of Procedures for Neuropsychological Assessment for Neurocognitive Disorders: Standardization and Clinical Validation of the Teleneuropsychology Platform Tenèpsia®
- ClinicalTrials.gov ID
- NCT07664865
- Acronym / sponsor ID
- Tenepsia
- Conditions
- Cognitive Impairment
- Keywords
- teleneuropsychology, cognitive disorders, digitalization, remote assessment, dementia, neurodegenerative disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- IRCCS National Neurological Institute "C. Mondino" FoundationUniversity, hospital or other
- 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
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 24 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 200 healthy subjects | – | –equally distributed between the collaborating centers |
| 50 patients | – | –equally distributed between the collaborating centers |
Who may qualify
- Ages
- 40 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 200 healthy subjects and 50 patients with a diagnosis of Mild Neurocognitive Disorder (mNCD), equally distributed between the collaborating centers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Collecting normative data
Time frame: At baseline
Administration of the tablet-based battery to a sample of healthy subjects in a single session lasting approximately 45/60 minutes (Phase 1 objective)
Free and Cued Selective Reminding Test (FCSRT)
Time frame: At baseline
Verbal episodic memory assessed by the FCSRT. The digital version includes 16 words presented in four sets of four items. Free recall scores range from 0 to 48 and total recall scores range from 0 to 48. Higher scores indicate better verbal leraning and memory performance.
Spatial Supraspan
Time frame: At baseline
Visuospatial working memory assessed by the Spatial Supraspan test. Participants are required to reproduce increasingly longer spatial sequences presented on the tablet. Higher scores indicate better visuospatial memory performance.
Rey-Osterrieth Complex Figure Delayed Recall
Time frame: At baseline
Visual episodic memory assessed by the Rey-Osterrieth Complex Figure delayed recall task. Scores range from 0 to 36. Higher scores indicate better visual memory performance.
Phonemic and Semantic Verbal Fluency
Time frame: At baseline
Language and executive functioning assessed through phonemic and semantic verbal fluency tasks. Participants are required to generate words belonging to a semantic category or beginning with a target letter within a fixed time interval. The score corresponds to the number of correct words produced. Higher scores indicate better language and executive functioning.
Complex Picture Description Test
Time frame: At baseline
Spontaneous speech production assessed using the complex picture description task from the Screening of Aphasia in NeuroDegeneration (SAND) battery. The score is based on the number of nouns, verbs and complete sentences produced. Higher scores indicate better language production abilities.
Picture Naming Test
Time frame: At baseline
Lexical-semantic abilities assessed by a picture naming task including 16 coloured living and non-living objects. Scores range from 0 to 16. Higher scores indicate better naming performance and lexical retrieval abilities.
Rey-Osterrieth Complex Figure Copy
Time frame: At baseline
Visuoconstructional abilities assessed by the Rey-Osterrieth Complex Figure copy task. Scores range from 0 to 36. Higher scores indicate better visuospatial and constructional abilities.
Pentagon Copying Test
Time frame: At baseline
Visuoconstructional abilities assessed through copying intersecting pentagons. Higher scores indicate better visuospatial and constructional performance.
Clock Drawing Test
Time frame: At baseline
Visuospatial and executive functioning assessed by the Clock Drawing Test. Higher scores indicate better visuoconstructional and executive abilities.
Symbol Digit Modalities Test (SDMT)
Time frame: At baseline
Attention, processing speed and executive functioning assessed by the SDMT. The score corresponds to the number of correct symbol-digit associations completed within the allotted time. Higher scores indicate better cognitive processing speed and attention.
Stroop Test
Time frame: At baseline
Executive functioning and inhibitory control assessed by the Stroop Test. Scores are based on response accuracy and interference effects across test conditions. Better performance is reflected by fewer errors and lower interference.
Emotion Recognition Test
Time frame: At baseline
Social cognition assessed by the Emotion Recognition Test. The digital version includes 28 facial stimuli depicting basic emotions and neutral expressions. Scores range from 0 to 28. Higher scores indicate better recognition of facial emotions and social cognitive functioning.
Geriatric Depression Scale (GDS-15)
Time frame: At baseline
Depressive symptoms assessed by the 15-item GDS. Scores range from 0 to 15. Higher scores indicate more severe depressive symptoms. A score of 5 or greater suggests clinically relevant depressive symptoms.
Activities of Daily Living (ADL)
Time frame: At baseline
Basic functional independence assessed by the ADL scale. Scores range from 0 to 6. Higher scores indicate greater independence in daily functioning.
Instrumental Activities of Daily Living (IADL)
Time frame: At baseline
Functional independence in complex daily activities assessed by the IADL scale. Scores range from 0 to 8. Higher scores indicate greater functional independence.
5 secondary outcomes
Learning and Memory: FCSRT, Spatial Supraspan, Rey-Osterrieth Complex Figure Delayed Recall.
Time frame: At baseline
Language: Picture Naming Test, Phonemic and Semantic Verbal Fluency, Complex Picture Description Test.
Time frame: At baseline
Visuo-perceptual and Constructional Skills: Rey-Osterrieth Complex Figure Copy, Pentagon Copying Test, Clock Drawing Test.
Time frame: At baseline
Attention and Executive Functions: SDMT, Stroop Test.
Time frame: At baseline
Evaluation of the usability and user-experience
Time frame: At baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Background: PubMed 28155182Bosco A, Spano G, Caffo AO, Lopez A, Grattagliano I, Saracino G, Pinto K, Hoogeveen F, Lancioni GE. Italians do it worse. Montreal Cognitive Assessment (MoCA) optimal cut-off scores for people with probable Alzheimer's disease and with probable cognitive impairment. Aging Clin Exp Res. 2017 Dec;29(6):1113-1120. doi: 10.1007/s40520-017-0727-6. Epub 2017 Feb 2.
- Background: PubMed 35982477Conca F, Esposito V, Rundo F, Quaranta D, Muscio C, Manenti R, Caruso G, Lucca U, Galbussera AA, Di Tella S, Baglio F, L'Abbate F, Canu E, Catania V, Filippi M, Mattavelli G, Poletti B, Silani V, Lodi R, De Matteis M, Stanzani Maserati M, Arighi A, Rotondo E, Tanzilli A, Pace A, Garramone F, Cavaliere C, Pardini M, Rizzetto C, Sorbi S, Perri R, Tiraboschi P, Canessa N, Cotelli M, Ferri R, Weintraub S, Marra C, Tagliavini F, Catricala E, Cappa SF. Italian adaptation of the Uniform Data Set Neuropsychological Test Battery (I-UDSNB 1.0): development and normative data. Alzheimers Res Ther. 2022 Aug 19;14(1):113. doi: 10.1186/s13195-022-01056-x.
- Background: PubMed 31248465Stasenko A, Jacobs DM, Salmon DP, Gollan TH. The Multilingual Naming Test (MINT) as a Measure of Picture Naming Ability in Alzheimer's Disease. J Int Neuropsychol Soc. 2019 Sep;25(8):821-833. doi: 10.1017/S1355617719000560. Epub 2019 Jun 28.
- Background: PubMed 33927583Staffaroni AM, Tsoy E, Taylor J, Boxer AL, Possin KL. Digital Cognitive Assessments for Dementia: Digital assessments may enhance the efficiency of evaluations in neurology and other clinics. Pract Neurol (Fort Wash Pa). 2020 Nov-Dec;2020:24-45. No abstract available.
- Background: PubMed 22382386Bauer RM, Iverson GL, Cernich AN, Binder LM, Ruff RM, Naugle RI. Computerized neuropsychological assessment devices: joint position paper of the American Academy of Clinical Neuropsychology and the National Academy of Neuropsychology. Arch Clin Neuropsychol. 2012 May;27(3):362-73. doi: 10.1093/arclin/acs027. Epub 2012 Mar 1.
- Background: PubMed 32844714Hammers DB, Stolwyk R, Harder L, Cullum CM. A survey of international clinical teleneuropsychology service provision prior to and in the context of COVID-19. Clin Neuropsychol. 2020 Oct-Nov;34(7-8):1267-1283. doi: 10.1080/13854046.2020.1810323. Epub 2020 Aug 26.
- Background: PubMed 32666093Bilder RM, Postal KS, Barisa M, Aase DM, Cullum CM, Gillaspy SR, Harder L, Kanter G, Lanca M, Lechuga DM, Morgan JM, Most R, Puente AE, Salinas CM, Woodhouse J. Inter Organizational Practice Committee Recommendations/Guidance for Teleneuropsychology in Response to the COVID-19 Pandemicdagger. Arch Clin Neuropsychol. 2020 Aug 28;35(6):647-659. doi: 10.1093/arclin/acaa046.
- Background: PubMed 32519594Marra DE, Hamlet KM, Bauer RM, Bowers D. Validity of teleneuropsychology for older adults in response to COVID-19: A systematic and critical review. Clin Neuropsychol. 2020 Oct-Nov;34(7-8):1411-1452. doi: 10.1080/13854046.2020.1769192. Epub 2020 Jun 10.
- Background: PubMed 34937315Gareev I, Gallyametdinov A, Beylerli O, Valitov E, Alyshov A, Pavlov V, Izmailov A, Zhao S. The opportunities and challenges of telemedicine during COVID-19 pandemic. Front Biosci (Elite Ed). 2021 Dec 20;13(2):291-298. doi: 10.52586/E885.
- Background: PubMed 33388003Colbert GB, Venegas-Vera AV, Lerma EV. Utility of telemedicine in the COVID-19 era. Rev Cardiovasc Med. 2020 Dec 30;21(4):583-587. doi: 10.31083/j.rcm.2020.04.188.
- Background: PubMed 33314910Lukas H, Xu C, Yu Y, Gao W. Emerging Telemedicine Tools for Remote COVID-19 Diagnosis, Monitoring, and Management. ACS Nano. 2020 Dec 22;14(12):16180-16193. doi: 10.1021/acsnano.0c08494. Epub 2020 Dec 14.
- Background: PubMed 33300414Hincapie MA, Gallego JC, Gempeler A, Pineros JA, Nasner D, Escobar MF. Implementation and Usefulness of Telemedicine During the COVID-19 Pandemic: A Scoping Review. J Prim Care Community Health. 2020 Jan-Dec;11:2150132720980612. doi: 10.1177/2150132720980612.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara Bottiroli, PhD principal investigator
Unit of Research in Cognitive Psycology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Impairment, run by IRCCS National Neurological Institute "C. Mondino" Foundation at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collecting normative data (time frame: At baseline). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07664865, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.