Advances in Neuropsychological Diagnostics
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Change from baseline in Brief Assessment of Social Skills-Dementia (BASS-D)
研究概览
简要总结
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinical populations: clinical diagnosis of either neurological (e.g., vascular and degenerative aetiologies) or psychiatric disorders.
- •Healthy controls: not applicable
排除标准
- •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.
结局指标
主要结局
Change from baseline in Brief Assessment of Social Skills-Dementia (BASS-D)
时间窗: 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
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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
时间窗: 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
次要结局
未报告次要终点