Advances in Neuropsychological Diagnostics
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Istituto Auxologico Italiano
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Change from baseline in Brief Assessment of Social Skills-Dementia (BASS-D)
Study Overview
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).
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 20 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Secondary Outcomes
No secondary outcomes reported