Functional and Behavioural Scales Validation in Italian.

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 60
Healthy Volunteers: t
View:

• 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).

Locations
Other Locations
Italy
Casa di Cura Igea
RECRUITING
Milan
Contact Information
Primary
Sabrina Guzzetti, Psychologist
s.guzzetti@casadicurigea.it
+390248593315
Backup
Laura Veronelli, PhD
laura.veronelli@unimib.it
+390264483704
Time Frame
Start Date: 2024-11-26
Estimated Completion Date: 2026-11-30
Participants
Target number of participants: 390
Treatments
Neurologically unimpaired participants
i) Age ≥ 60 years; ii) Availability of an informant/caregiver, able to judge their functional abilities; iii) Normal performance on the Mini Mental State Examination (Folstein et al. 1975; Foderaro et al., 2022).
Subjective Cognitive Decline (SCD)
i) Age ≥ 60 years; ii) Availability of an informant/caregiver, able to judge their functional abilities.~iii) Conditions consistent with Subjective Cognitive Decline according to Jessen et al. (2014)
Mild Cognitive Impairment (MCI)
i) Age ≥ 60 years; ii) Availability of an informant/caregiver, able to judge their functional abilities.~iii) Conditions consistent with Mild Cognitive Impairment according to Winblad et al. (2004)
Major Neurocognitive Disorder
i) Age ≥ 60 years; ii) Availability of an informant/caregiver, able to judge their functional abilities iii) Conditions consistent with a Mild Major Neurocognitive Disorder according to DSM-5-TR (APA, 2022).
Related Therapeutic Areas
Sponsors
Leads: Casa di Cura IGEA

This content was sourced from clinicaltrials.gov