Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05794061

Advances in Neuropsychological Diagnostics

This project is aimed at advancing neuropsychological diagnostics, enriching and modernizing the panorama of both clinical and forensic psychometric testing. The rapid socio-demographic changes, the developments of neuropsychological semiotics and nosography, as well as the growing applicative specialization of neuropsychological assessment make it necessary to introduce further tools to satisfy the diagnostic requests in clinical contexts and more recently in the forensic field (i.e., tests to be administered remotely; bedside screeners; domain-specific in-depth tests; tools for assessing testamentary capacity).

Specifically, the present study aims to: a) develop, calibrate and evaluate the psychometric properties of I and II level clinical and/or forensic neuropsychological tests evaluating instrumental and non-instrumental functions in a sample of neurologically healthy individuals representative of the Italian population ; b) evaluate the cross-sectional and longitudinal clinical usability of the aforementioned tests in clinical samples (patients with neurological and neuropsychiatric pathologies of different etiology).

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Cognitive Impairment Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Psychiatric Disorder

Age range

20 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istituto Auxologico Italiano IRCCS

Milan, Lombardy, 20122, Italy

Location status: Recruiting

Location contact

Nadia Bolognini, PhD

CONTACT

[email protected]

+390261911 ext. 6127

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical populations: clinical diagnosis of either neurological (e.g., vascular and degenerative aetiologies) or psychiatric disorders.
  • Healthy controls: not applicable

Exclusion criteria

  • Clinical populations:
  • Clinical diagnosis not of interest;
  • Severe general medical conditions;
  • Uncorrected vision/hearing deficits.
  • Healthy controls:
  • Presence of brain disorders;
  • Severe general medical conditions;
  • Uncorrected vision/hearing deficits.

Treatment and study plan

Neuropsychological instruments

Behavioral

Cognitive and behavioral tests and questionnaires

Primary outcomes

  1. Change from baseline in Brief Assessment of Social Skills-Dementia (BASS-D)

    Time frame: At baseline (i.e., at the enrollment; all participants); after 1 month (for test-retest analyses in neurologically healthy individuals); after 6, 12, and 18 months in participants with neurodegenerative disorders

    A screening test of social cognition in neurodegeneration

  2. Change from baseline in Picture Interpretation Test (PIT)

    Time frame: At baseline (i.e., at the enrollment; all participants); after 1 month (for test-retest analyses in neurologically healthy individuals); after 6, 12, and 18 months in participants with neurodegenerative disorders

    A test of executive functions

  3. Change from baseline in Verbal Reasoning Test (VRT-A) - Absurdity sub-test

    Time frame: At baseline (i.e., at the enrollment; all participants); after 1 month (for test-retest analyses in neurologically healthy individuals); after 6, 12, and 18 months in participants with neurodegenerative disorders

    A test of verbal reasoning

  4. Change from baseline in Brief Executive Language Screen (BELS)

    Time frame: At baseline (i.e., at the enrollment; all participants); after 1 month (for test-retest analyses in neurologically healthy individuals); after 6, 12, and 18 months in participants with neurodegenerative disorders

    A language test

  5. Change from baseline in Bamberg Dementia Screening Test (BDST)

    Time frame: At baseline (i.e., at the enrollment; all participants); after 1 month (for test-retest analyses in neurologically healthy individuals); after 6, 12, and 18 months in participants with neurodegenerative disorders

    A test of global cognitive efficiency

  6. Change from baseline in Testament Definition Scale (TDS)

    Time frame: At baseline (i.e., at the enrollment; all participants); after 1 month (for test-retest analyses in neurologically healthy individuals); after 6, 12, and 18 months in participants with neurodegenerative disorders

    A scale to assess testament representation

  7. Change from baseline in Testamentary Capacity Assessment Tool (TCAT)

    Time frame: At baseline (i.e., at the enrollment; all participants); after 1 month (for test-retest analyses in neurologically healthy individuals); after 6, 12, and 18 months in participants with neurodegenerative disorders

    A test to assess cognitive functions (i.e., memory, executive functions, social cognition, and numerical abilities) at the base of testamentary capacity

  8. Change from baseline in Telephone Interview for Cognitive Status (TICS)

    Time frame: At baseline (i.e., at the enrollment; all participants); after 1 month (for test-retest analyses in neurologically healthy individuals); after 6, 12, and 18 months in participants with neurodegenerative disorders

    A telephone-based screening test of global cognitive efficiency

  9. Change from baseline in Telephone-based Mini-Mental State Examination (I-TEL-MMSE)

    Time frame: At baseline (i.e., at the enrollment; all participants); after 1 month (for test-retest analyses in neurologically healthy individuals); after 6, 12, and 18 months in participants with neurodegenerative disorders

    A telephone-based screening test of global cognitive efficiency

  10. Change from baseline in Telephone-based Global Examination of Mental State (tele-GEMS)

    Time frame: At baseline (i.e., at the enrollment; all participants); after 1 month (for test-retest analyses in neurologically healthy individuals); after 6, 12, and 18 months in participants with neurodegenerative disorders

    A telephone-based screening test of global cognitive efficiency

  11. Change from baseline in Telephone-based Amyotrophic Lateral Sclerosis Cognitive Behavioural Screen (ALS-CBS™-PhV

    Time frame: At baseline (i.e., at the enrollment; all participants); after 1 month (for test-retest analyses in neurologically healthy individuals); after 6, 12, and 18 months in participants with neurodegenerative disorders

    A telephone-based screening test for cognitive functions in ALS

  12. Change from baseline in Telephone-based Frontal Assessment Battery (t-FAB)

    Time frame: At baseline (i.e., at the enrollment; all participants); after 1 month (for test-retest analyses in neurologically healthy individuals); after 6, 12, and 18 months in participants with neurodegenerative disorders

    A telephone-based screening test of executive functions

  13. Change from baseline in Development of the Bizzare Pictures Test (BPT)

    Time frame: At baseline (i.e., at the enrollment; all participants); after 1 month (for test-retest analyses in neurologically healthy individuals); after 6, 12, and 18 months in participants with neurodegenerative disorders

    A new visual test to assess reasoning abilities

  14. Change from baseline in Development Telephone Language Screener (TLS)

    Time frame: At baseline (i.e., at the enrollment; all participants); after 1 month (for test-retest analyses in neurologically healthy individuals); after 6, 12, and 18 months in participants with neurodegenerative disorders

    A new telephone-based test to asses linguistic functions

Study contacts

Contact information is provided by the study sponsor or research team.

Nadia Bolognini, PhD

CONTACT

[email protected]

+390261911 ext. 6127

Sponsors and collaborators

Lead sponsor

Istituto Auxologico Italiano

Other

Registry information

Acronym: NeuroPsiD

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Mar 31, 2023
Registry last updated
Sep 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.