Italian Adaptation and Validation of Functional and Behavioural Scales for Subjective Cognitive Decline, Mild Cognitive Impairment and Mild Dementia.
Eligible age
60+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
Yes
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About this study
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.
Sponsor: Casa di Cura IGEA
You may qualify if…
- ✓ 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).
You may not qualify if…
- ✕ 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 recruiting
Milan
Source: ClinicalTrials.gov · NCT06701630 · last updated 2025-02-13