Clinical trial Recruiting at 1 site Observational Ages 60 and up

Validation of Italian cognitive assessment scales for elderly patients

Official title: Functional and Behavioural Scales Validation in Italian.

Run by Casa di Cura IGEA · NCT06701630 · Data updated 2026-11-12

This study is trying to see if new Italian versions of cognitive and daily living assessments can help doctors better diagnose neurodegenerative diseases in older Italian-speaking patients.

More Mild Cognitive Impairment (MCI) trials

Quick facts

Study typeObservational
Ages60 Years and up
SexAll
Enrollment390 (estimated)
SponsorCasa di Cura IGEA
Academic / other
Locations1 site (Milan, Michigan)
StatusRecruiting
StartedNovember 26, 2024
Main results expectedNovember 30, 2026
Study endsNovember 30, 2026
Registry record updatedFebruary 13, 2025
Trial IDNCT06701630 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include elderly individuals aged 60 and above, with either subjective cognitive decline, mild cognitive impairment, or mild major neurocognitive disorder.

Probably not a fit

Patients with other neurological or psychiatric conditions that could explain cognitive difficulties may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to translate, adapt, and validate functional and behavioral scales for diagnosing neurodegenerative diseases in Italian-speaking populations. It focuses on tools such as the Basic Activities of Daily Living (BADL), Instrumental Activities of Daily Living (IADL), Everyday Cognition questionnaire (ECog), and Neuropsychiatric Inventory Questionnaire (NPI-Q). The study will also evaluate the psychometric properties of a modified Italian version of the Functional Activities Questionnaire (M-FAQ). By ensuring these tools are culturally relevant and scientifically validated, the study seeks to improve diagnostic accuracy for conditions like Mild Cognitive Impairment and Mild Dementia.

Why it matters

Potential benefit: If successful, this study could provide validated assessment tools that enhance the diagnosis and management of cognitive decline in Italian-speaking elderly patients.

How similar studies have gone: Other studies have shown success in validating cognitive assessment tools in various languages, suggesting that this approach is both relevant and necessary.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Age ≥ 60 years;
* Availability of an informant/caregiver, able to judge their functional abilities.

For neurologically unimpaired elderly:

\- Normal performance on the Mini Mental State Examination (Folstein et al. 1975; Foderaro et al., 2022).

For clinical groups: Conditions consistent with:

* Subjective Cognitive Decline (Jessen et al., 2014)
* Mild Cognitive Impairment (Winblad et al., 2004)
* Mild Major Neurocognitive Disorder according (DSM-5-TR, APA, 2022).

Exclusion Criteria:

* Refusal or inability to sign informed consent;
* For the clinical groups: other neurological or psychiatric conditions that may explain the presence of cognitive difficulties.

Where it's running

  • Casa di Cura Igea
    Milan, Michigan, Italy
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.