RecruitingNCT06701630

Italian Adaptation and Validation of Functional and Behavioural Scales for Subjective Cognitive Decline, Mild Cognitive Impairment and Mild Dementia.

Functional and Behavioural Scales Validation in Italian.

Sponsor

Casa di Cura IGEA

Enrollment

390 participants

Start Date

Nov 26, 2024

Study Type

OBSERVATIONAL

Conditions

Mild Cognitive Impairment (MCI)Subjective Cognitive Decline (SCD)Major Neurocognitive Disorder Neurologically Unimpaired Elderly Participants

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

Min Age: 60 Years

Inclusion Criteria8

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 Criteria2

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

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