Advances in Neuropsychological Diagnostics

Study Overview
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Brief Summary
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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).

Official Title
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Advances in Neuropsychological Diagnostics

Conditions
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Cognitive Impairment, Dementia, Psychiatric Disorder

Intervention / Treatment
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* Behavioral: Neuropsychological instruments


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients<br>Patients with brain disorders | Behavioral: Neuropsychological instruments<br>* Cognitive and behavioral tests and questionnaires<br>|
| Healthy controls<br>Neurologically Healthy Controls | Behavioral: Neuropsychological instruments<br>* Cognitive and behavioral tests and questionnaires<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |