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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age60+
SponsorCasa di Cura IGEA

About this trial

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

This trial accepts healthy volunteers

Qualifiers

Age ≥ 60 years;

Availability of an informant/caregiver, able to judge their functional abilities.

Subjective Cognitive Decline (Jessen et al., 2014)

Mild Cognitive Impairment (Winblad et al., 2004)

Disqualifiers

Refusal or inability to sign informed consent;

For the clinical groups: other neurological or psychiatric conditions that may explain the presence of cognitive difficulties.

Trial population

The study will enroll neurologically unimpaired participants and participants with SCD, MCI, and mild dementia referred to the Center for Cognitive Disorders and Dementia.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

390 Participants
are grouped into 4 trial groups
Group A: Neurologically unimpaired participants
Group B: Subjective Cognitive Decline (SCD)
Group C: Mild Cognitive Impairment (MCI)
Group D: Major Neurocognitive Disorder

Trial outcomes

Primary outcomes

1

Everyday Cognition questionnaire score

The tool assesses functional changes in specific cognitive domains (memory, language, visuospatial skills, and executive functions).

Time frame
From enrollment to the end of the assessment (1 day)

Secondary outcomes

1

Basic Activities of Daily Living (BADL) score

The tool assesses functional autonomy in simple everyday activities.

Time frame
From enrollment to the end of the assessment (1 day)
2

Instrumental Activities of Daily Living (IADL) score

The tool assesses functional autonomy in instrumental everyday activities.

Time frame
From enrollment to the end of the assessment (1 day)
3

Functional Activities Questionnaire (FAQ) score

The tool assesses functional autonomy in complex everyday activities

Time frame
From enrollment to the end of the assessment (1 day)
4

Neuropsychiatric Inventory Questionnaire (NPI-Q) score

The tool assesses Behavioral and Psychological Symptoms of Dementia (BPSD) , covering a wide range of neuropsychiatric symptoms.

Time frame
From enrollment to the end of the assessment (1 day)

Other outcomes

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