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

Recruiting now

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

In brief

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.

Key facts

Study ID

NCT06701630

Run by

Casa di Cura IGEA

People needed

390

Starts

2024-11-26

Expected to finish

2026-11-30

Last updated by the study team

2025-02-13

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: accepted.

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 is running

• Casa di Cura Igea — Milan, Michigan, Italy (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.