Clinical trial NCT05794061: Advances in Neuropsychological Diagnostics
Official title: Advances in Neuropsychological Diagnostics
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cognitive Impairment
Dementia
Psychiatric Disorder
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
First posted: 2023-03-31
Enrollment: 300
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with brain disorders and normotypical.

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).


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:

  1. Clinical diagnosis not of interest;
  2. Severe general medical conditions;
  3. Uncorrected vision/hearing deficits.
* Healthy controls:

  1. Presence of brain disorders;
  2. Severe general medical conditions;
  3. Uncorrected vision/hearing deficits.

Primary outcomes:
measure: Change from baseline in Brief Assessment of Social Skills-Dementia (BASS-D)
timeFrame: 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
measure: Change from baseline in Picture Interpretation Test (PIT)
timeFrame: 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
measure: Change from baseline in Verbal Reasoning Test (VRT-A) - Absurdity sub-test
timeFrame: 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
measure: Change from baseline in Brief Executive Language Screen (BELS)
timeFrame: 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
measure: Change from baseline in Bamberg Dementia Screening Test (BDST)
timeFrame: 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
measure: Change from baseline in Testament Definition Scale (TDS)
timeFrame: 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
measure: Change from baseline in Testamentary Capacity Assessment Tool (TCAT)
timeFrame: 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
measure: Change from baseline in Telephone Interview for Cognitive Status (TICS)
timeFrame: 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
measure: Change from baseline in Telephone-based Mini-Mental State Examination (I-TEL-MMSE)
timeFrame: 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
measure: Change from baseline in Telephone-based Global Examination of Mental State (tele-GEMS)
timeFrame: 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
measure: Change from baseline in Telephone-based Amyotrophic Lateral Sclerosis Cognitive Behavioural Screen (ALS-CBS™-PhV
timeFrame: 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
measure: Change from baseline in Telephone-based Frontal Assessment Battery (t-FAB)
timeFrame: 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
measure: Change from baseline in Development of the Bizzare Pictures Test (BPT)
timeFrame: 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
measure: Change from baseline in Development Telephone Language Screener (TLS)
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Istituto Auxologico Italiano IRCCS
state: Lombardia
Study officials:
References: