Harmonization of Teleneuropsychological Assessment in Dementia

NCT07664865 | Completed

• 1 other identifier: Tenepsia
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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

Cognitive Impairment

Keywords

teleneuropsychology; cognitive disorders; digitalization; remote assessment; dementia; neurodegenerative disorders

Outcome Measures

Primary Outcomes (16)

• 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)

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  At baseline

• Pentagon Copying Test

  Visuoconstructional abilities assessed through copying intersecting pentagons. Higher scores indicate better visuospatial and constructional performance.

  At baseline

• Clock Drawing Test

  Visuospatial and executive functioning assessed by the Clock Drawing Test. Higher scores indicate better visuoconstructional and executive abilities.

  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.

  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.

  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.

  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.

  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.

  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.

  At baseline

Secondary Outcomes (5)

• Learning and Memory: FCSRT, Spatial Supraspan, Rey-Osterrieth Complex Figure Delayed Recall.

  At baseline

• Language: Picture Naming Test, Phonemic and Semantic Verbal Fluency, Complex Picture Description Test.

  At baseline

• Visuo-perceptual and Constructional Skills: Rey-Osterrieth Complex Figure Copy, Pentagon Copying Test, Clock Drawing Test.

  At baseline

• Attention and Executive Functions: SDMT, Stroop Test.

  At baseline

• Evaluation of the usability and user-experience

  At baseline

Study Arms (2)

200 healthy subjects

equally distributed between the collaborating centers

50 patients

equally distributed between the collaborating centers

Eligibility Criteria

• Age: 40 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

200 healthy subjects and 50 patients with a diagnosis of Mild Neurocognitive Disorder (mNCD), equally distributed between the collaborating centers

You may not qualify if:

• Criteria of Pathological subjects:

Sponsors & Collaborators

• IRCCS National Neurological Institute "C. Mondino" Foundation: lead
• University of Bari Aldo Moro: collaborator
• University of Campania Luigi Vanvitelli: collaborator
• Università degli Studi di Trento: collaborator
• IRCCS Istituto delle Scienze Neurologiche di Bologna: collaborator
• University of Palermo: collaborator
• Asst Degli Spedali Civili Di Brescia: collaborator
• Azienda Usl di Bologna: collaborator
• Istituto Auxologico Italiano: collaborator

Study Sites (1)

Unit of Research in Cognitive Psychology

Pavia, 27100, Italy

Location

Related Publications (18)

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• Boccardi M, Monsch AU, Ferrari C, Altomare D, Berres M, Bos I, Buchmann A, Cerami C, Didic M, Festari C, Nicolosi V, Sacco L, Aerts L, Albanese E, Annoni JM, Ballhausen N, Chicherio C, Demonet JF, Descloux V, Diener S, Ferreira D, Georges J, Gietl A, Girtler N, Kilimann I, Kloppel S, Kustyniuk N, Mecocci P, Mella N, Pigliautile M, Seeher K, Shirk SD, Toraldo A, Brioschi-Guevara A, Chan KCG, Crane PK, Dodich A, Grazia A, Kochan NA, de Oliveira FF, Nobili F, Kukull W, Peters O, Ramakers I, Sachdev PS, Teipel S, Visser PJ, Wagner M, Weintraub S, Westman E, Froelich L, Brodaty H, Dubois B, Cappa SF, Salmon D, Winblad B, Frisoni GB, Kliegel M; Consortium for the Harmonization of Neuropsychological Assessment for Neurocognitive Disorders (https://nextcloud.dzne.de/index.php/s/EwXjLab9caQTbQe). Harmonizing neuropsychological assessment for mild neurocognitive disorders in Europe. Alzheimers Dement. 2022 Jan;18(1):29-42. doi: 10.1002/alz.12365. Epub 2021 May 13.

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MeSH Terms

Conditions

Cognitive Dysfunction; Dementia; Neurodegenerative Diseases

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Sara Bottiroli, PhD

  Unit of Research in Cognitive Psycology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2026
• First Posted: June 24, 2026
• Study Start: December 1, 2024
• Primary Completion: July 31, 2025
• Study Completion: December 31, 2025
• Last Updated: June 24, 2026

Record last verified: 2026-06

Locations

IT (1)