Advances in Neuropsychological Diagnostics

NCT05794061 | Recruiting

• 1 other identifier: 25C122
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Cognitive Impairment; Dementia; Psychiatric Disorder

Outcome Measures

Primary Outcomes (14)

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

  A screening test of social cognition in neurodegeneration

  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

• Change from baseline in Picture Interpretation Test (PIT)

  A test of executive functions

  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

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

  A test of verbal reasoning

  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

• Change from baseline in Brief Executive Language Screen (BELS)

  A language test

  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

• Change from baseline in Bamberg Dementia Screening Test (BDST)

  A test of global cognitive efficiency

  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

• Change from baseline in Testament Definition Scale (TDS)

  A scale to assess testament representation

  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

• Change from baseline in Testamentary Capacity Assessment Tool (TCAT)

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

  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

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

  A telephone-based screening test of global cognitive efficiency

  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

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

  A telephone-based screening test of global cognitive efficiency

  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

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

  A telephone-based screening test of global cognitive efficiency

  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

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

  A telephone-based screening test for cognitive functions in ALS

  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

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

  A telephone-based screening test of executive functions

  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

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

  A new visual test to assess reasoning abilities

  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

• Change from baseline in Development Telephone Language Screener (TLS)

  A new telephone-based test to asses linguistic functions

  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

Study Arms (2)

Patients

Patients with brain disorders

Behavioral: Neuropsychological instruments

Healthy controls

Neurologically Healthy Controls

Behavioral: Neuropsychological instruments

Interventions

Neuropsychological instruments BEHAVIORAL

Cognitive and behavioral tests and questionnaires

Healthy controls; Patients

Eligibility Criteria

• Age: 20 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals with brain disorders and normotypical.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituto Auxologico Italiano: lead

Study Sites (1)

Istituto Auxologico Italiano IRCCS

Milan, Lombardy, 20122, Italy

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction; Dementia; Mental Disorders

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Nadia Bolognini, PhD

CONTACT

+390261911; n.bolognini@auxologico.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2023
• First Posted: March 31, 2023
• Study Start: November 11, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 17, 2025

Record last verified: 2025-09

Locations

IT (1)