Advances in Neuropsychological Diagnostics

Обзор

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).

Вмешательства

• Поведенческое Neuropsychological instruments
  Cognitive and behavioral tests and questionnaires

Первичные конечные точки

• Change from baseline in Brief Assessment of Social Skills-Dementia (BASS-D) [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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]

Критерии участия

Критерии включения

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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Италия · 1 центр

• Istituto Auxologico Italiano IRCCS — Milan

Идентификаторы

NCT: NCT05794061 · 25C122

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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