NCT06701630 Italian Adaptation and Validation of Functional and Behavioural Scales for Subjective Cognitive Decline, Mild Cognitive Impairment and Mild Dementia.
| NCT ID | NCT06701630 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Casa di Cura IGEA |
| Condition | Neurologically Unimpaired Elderly Participants |
| Study Type | OBSERVATIONAL |
| Enrollment | 390 participants |
| Start Date | 2024-11-26 |
| Primary Completion | 2026-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 390 participants in total. It began in 2024-11-26 with a primary completion date of 2026-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The first aim of the observational study is the translation, cross-cultural adaptation and validation of functional and behavioral scales used in the diagnosis of neurodegenerative diseases, for which a formal version in Italian is not available at present. In particular, the study includes the following functional and behavioral scales: the Katz's index (Basic Activities of Daily Living, BADL), the Lawton and Brody's scale (Instrumental Activities of Daily Living, IADL), the Everyday Cognition questionnaire (E-Cog), the Neuropsychiatric Inventory Questionnaire (NPI-Q) for assessing the Behavioral and Psychological Symptoms of Dementia. Furthermore, a modified Italian version of the Functional Activities Questionnaire (FAQ), which integrates and updates the content of the original items (e.g., addressing the use of technologies, M-FAQ) will be used in the validation study. The second aim is to evaluate the psychometric properties of the M-FAQ, the ECog, and the NPI-Q in terms of reliability and validity. The third aim is to apply a Receiver Operating Characteristic (ROC) curve analysis to identify cut-offs of IADL, M-FAQ and ECOG to discriminate between different clinical groups (i.e., neurologically unimpaired elderly; Subjective Cognitive Decline, SCD; Mild Cognitive Impairment, MCI; mild Alzheimer's Disease, AD). Neurologically unimpaired elderly participants (over 60 years old) and participants with SCD, MCI, mild AD, and their caregivers/informants will undergo: i) administration of the translated versions of the scales; ii) administration of a Cognitive Reserve questionnaire. For SCD, MCI and AD participants, data from the clinical neuropsychological evaluation will also be collected, while paper-and-pencil psychometric tests to assess global cognitive functioning (Mini Mental State Examination) and logical-abstract reasoning (Raven's Colored Matrices) will be administered to the neurologically unimpaired participants.
Eligibility 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.
Contact & Investigator
Sabrina Guzzetti
PRINCIPAL INVESTIGATOR
Casa di Cura IGEA, Milan, Italy
Frequently Asked Questions
Who can join the NCT06701630 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Neurologically Unimpaired Elderly Participants. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06701630 currently recruiting?
Yes, NCT06701630 is actively recruiting participants. Contact the research team at s.guzzetti@casadicurigea.it for enrollment information.
Where is the NCT06701630 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT06701630 clinical trial?
NCT06701630 is sponsored by Casa di Cura IGEA. The principal investigator is Sabrina Guzzetti at Casa di Cura IGEA, Milan, Italy. The trial plans to enroll 390 participants.