Advances in Neuropsychological Diagnostics

Dementia Clinical Trial

— NeuroPsiD  

Official title:

Advances in Neuropsychological Diagnostics

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05794061
• Other study ID #: 25C122
• Status: Recruiting
• Start date: November 11, 2021
• Est. completion date: December 31, 2026

Study information

• Verified date: March 2023
• Source: Istituto Auxologico Italiano
• Contact: Nadia Bolognini, PhD
• Phone: +390261911
• Email: n.bolognini[@]auxologico.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Impairment
• Dementia
• Mental Disorders
• Problem Behavior
• Psychiatric Disorder

Intervention

Behavioral:
• Neuropsychological instruments
Cognitive and behavioral tests and questionnaires

Locations

Country	Name	City	State
Italy	Istituto Auxologico Italiano IRCCS	Milan	Lombardia

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Auxologico Italiano

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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