Cognitive ImpairmentNeuroPsiDNCT05794061
Advances in Neuropsychological Diagnostics
An observational study of Cognitive Impairment and Dementia, run by Istituto Auxologico Italiano at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 20 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Impairment, Dementia, Psychiatric Disorder
- What is being tested?
- Neuropsychological instruments
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- 11 Nov 2021to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals with brain disorders and normotypical.
Who may be able to join
- Clinical populations: clinical diagnosis of either neurological (e.g., vascular and degenerative aetiologies) or psychiatric disorders.
- Healthy controls: not applicable
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Istituto Auxologico Italiano IRCCS
Milan, Lombardy, 20122
Nadia Bolognini, PhD, +390261911 ext. 6127, n.bolognini@auxologico.it
About this study
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).
- Conditions
- Cognitive Impairment, Dementia, Psychiatric Disorder
- Being tested
- Neuropsychological instruments
- Medical subject headings
- Cognitive Dysfunction, Dementia, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropsychological instrumentsBehavioural
Cognitive and behavioral tests and questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients with brain disorders Receives: Behavioral: Neuropsychological instruments | |
| Healthy controls | Neurologically Healthy Controls Receives: Behavioral: Neuropsychological instruments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Brief Assessment of Social Skills-Dementia (BASS-D)
A screening test of social cognition in neurodegeneration
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2023
- Study start11 Nov 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05794061
- Sponsor's protocol ID
- 25C122
- Acronym
- NeuroPsiD
- Status last verified
- Sep 2025
- First submitted
- 24 Feb 2023
- Last updated
- 17 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advances in Neuropsychological Diagnostics
- ClinicalTrials.gov ID
- NCT05794061
- Acronym / sponsor ID
- NeuroPsiD / 25C122
- Conditions
- Cognitive Impairment, Dementia, Psychiatric Disorder
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- 11 Nov 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 31 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Behavioral: Neuropsychological instrumentsPatients with brain disorders |
| Healthy controls | – | Behavioral: Neuropsychological instrumentsNeurologically Healthy Controls |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with brain disorders and normotypical.
Key inclusion criteria (2 listed)
- Clinical populations: clinical diagnosis of either neurological (e.g., vascular and degenerative aetiologies) or psychiatric disorders.
- Healthy controls: not applicable
Key exclusion criteria (8 listed)
- Clinical populations:
- Healthy controls:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuropsychological instrumentsCognitive and behavioral tests and questionnaires | Behavioural | Healthy controls, Patients |
Primary outcome
Change from baseline in Brief Assessment of Social Skills-Dementia (BASS-D)
Time frame: 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 Picture Interpretation Test (PIT)
Time frame: 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 Verbal Reasoning Test (VRT-A) - Absurdity sub-test
Time frame: 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 Brief Executive Language Screen (BELS)
Time frame: 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 Bamberg Dementia Screening Test (BDST)
Time frame: 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 Testament Definition Scale (TDS)
Time frame: 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 Testamentary Capacity Assessment Tool (TCAT)
Time frame: 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 Telephone Interview for Cognitive Status (TICS)
Time frame: 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)
Time frame: 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 Global Examination of Mental State (tele-GEMS)
Time frame: 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
Time frame: 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
Change from baseline in Telephone-based Frontal Assessment Battery (t-FAB)
Time frame: 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 of the Bizzare Pictures Test (BPT)
Time frame: 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 Development Telephone Language Screener (TLS)
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Impairment and Dementia, run by Istituto Auxologico Italiano at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nadia Bolognini, PhD (+390261911 ext. 6127, n.bolognini@auxologico.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Brief Assessment of Social Skills-Dementia (BASS-D) (time frame: 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). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2025.