Italian Adaptation and Validation of Functional and Behavioural Scales for Subjective Cognitive Decline, Mild Cognitive Impairment and Mild Dementia.
A legfontosabb adatok
- Ki végzi
- Casa di Cura IGEA
- Hol
- Olaszország1 helyszín, 1 országbanVálassz országot a helyszínekhez
- Azonosító
- Állapot
- Toboroz
- Résztvevők
- 390 fő, tervezett
- Kezdés
- 2024. nov. 26.
- Várható befejezés
- 2026. nov. 30.
- A vizsgálat típusa
- Megfigyeléses, 4 csoport
- A regiszteradat frissítve
- 2025. február 13.
Ki vehet részt
MI-összefoglaló
A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.
The trial is looking for people aged 60 or older without memory or thinking problems, and people with subjective cognitive decline, mild cognitive impairment or mild dementia. It tests Italian versions of questionnaires about daily activities and behaviour.
- Életkor
- 60 years or older
- Nem
- All sexes
- A betegség stádiuma
- Healthy older people with a normal Mini Mental State Examination result, or people with subjective cognitive decline (feeling that memory or thinking has worsened), mild cognitive impairment, or mild major neurocognitive disorder (mild dementia).
A részvétel fő kizáró okai
- No family member or caregiver who can judge the person's daily abilities
- Refusing or not able to sign informed consent
- For the patient groups: other neurological or psychiatric conditions that may explain the thinking problems
A regiszter feltételei, szó szerint
Mind a 8 feltétel megnézéseKevesebb
Ki vehet részt
- 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)
Ki nem vehet részt
- For the clinical groups: other neurological or psychiatric conditions that may explain the presence of cognitive difficulties
- Refusal or inability to sign informed consent
Ennek a vizsgálatnak nincs helyszíne itt: Egyesült Államok.
Egy országban van helyszíne. Válassz országot, hogy lásd a helyszíneket.
A vizsgálatról
Mit akar kideríteni a vizsgálat
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.
A teljes eredeti leírásKevesebb
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.
A vizsgálat 4 csoportja
- 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).
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakAdatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Hivatalos cím
- Functional and Behavioural Scales Validation in Italian.
- MI-összefoglaló
- A vizsgálat saját részvételi feltételeiből. Gépi kiolvasás: 2026. november 15.
- A regiszteradat frissítve
- 2025. február 13.