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Recruiting NCT05794061

Advances in Neuropsychological Diagnostics

Observational Cognitive Impairment Dementia Psychiatric Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Neuropsychological instruments.
Who it may be relevant to
Registry conditions: Cognitive Impairment, Dementia, Psychiatric Disorder. Basic parameters: 20 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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).

Interventions

  • Behavioral Neuropsychological instruments
    Cognitive and behavioral tests and questionnaires

Primary outcome measures

  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • Istituto Auxologico Italiano IRCCS — Milan

Identifiers

NCT: NCT05794061 · 25C122

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗