Validation of Italian cognitive assessment scales for elderly patients
Functional and Behavioural Scales Validation in Italian.
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.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 390 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | Casa di Cura IGEA Academic / other |
| Locations | 1 site (Milan, Michigan) |
| Trial ID | NCT06701630 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include elderly individuals aged 60 and above, with either subjective cognitive decline, mild cognitive impairment, or mild major neurocognitive disorder.
Not a fit: Patients with other neurological or psychiatric conditions that could explain cognitive difficulties may not benefit from this study.
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 performed: Other studies have shown success in validating cognitive assessment tools in various languages, suggesting that this approach is both relevant and necessary.
Eligibility criteria
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 this trial is running
Milan, Michigan
- Casa di Cura Igea — Milan, Michigan, Italy (Recruiting)
Study contacts
- Principal investigator: Sabrina Guzzetti — Casa di Cura IGEA, Milan, Italy
- Study coordinator: Sabrina Guzzetti, Psychologist
- Email: s.guzzetti@casadicurigea.it
- Phone: +390248593315
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.