Advances in Neuropsychological Diagnostics (NeuroPsiD)

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 Overview

• Status: Recruiting
• Conditions: Cognitive Impairment; Dementia; Psychiatric Disorder
• Intervention / Treatment: Behavioral: Neuropsychological instruments

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Nadia Bolognini, PhD; Phone Number: 6127 +390261911; Email: n.bolognini@auxologico.it

Study Locations

• Italy
  • Lombardy
    • Milan, Lombardy, Italy, 20122
      • Recruiting
      • Istituto Auxologico Italiano IRCCS
      • Contact: Nadia Bolognini, PhD; Phone Number: 6127 +390261911; Email: n.bolognini@auxologico.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Individuals with brain disorders and normotypical.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients; Patients with brain disorders	Behavioral: Neuropsychological instruments; Cognitive and behavioral tests and questionnaires
Healthy controls; Neurologically Healthy Controls	Behavioral: Neuropsychological instruments; Cognitive and behavioral tests and questionnaires

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Istituto Auxologico Italiano

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: February 24, 2023
• First Submitted That Met QC Criteria: March 20, 2023
• First Posted (Actual): March 31, 2023

Study Record Updates

• Last Update Posted (Estimated): September 17, 2025
• Last Update Submitted That Met QC Criteria: September 11, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction; Mental Disorders; Dementia
• Other Study ID Numbers: 25C122

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No