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Not Yet Recruiting NCT07533084

Italian Validation of the dNA Scale and Its Correlation With Neurocognitive Variables

Conditions: Active Aging Individuals Aged 65 and Over, Aging, Mild Cognitive Impairment (MCI), Dementia, Dementia Alzheimer Type, Subjective Memory Complaints, Probable Alzheimer's Disease

Sex: All
Ages: 65 Years – N/A
Healthy volunteers: Yes
Enrollment: 265
Sponsor: Neuromed IRCCS

Location: IRCCS Centro San Giovanni di Dio Fatebenefratelli Brescia BS

Summary

The goal of this experimental multicentric intervention study is to validate, in Italian, the dynamic Neurocognitive Adaptation (dNA) Scale, which has already been validated in English, among a healthy elderly population (aged 65 and older) residing in Italy and patients with dementia or Alzheimer's Disease. dNA is a questionnaire designed to assess both current and past levels of engagement in physical, cognitive, creative, and social activities. The study aims to recruit a total of 265 participants with mild cognitive impairment, subjective memory complaints, or dementia. These participants will be distributed among the 8 recruitment centers. Neuropsychological data, subjective measures, and MRI data will be collected and analyzed to address the following research questions: 1) Is there a positive correlation between scores on the dNA Scale and cognitive efficiency, as reflected in neuropsychological measures, such as episodic memory and executive functions? 2) Is there a correlation between dNA scores and improved functional connectivity within neural networks, such as the Default Network (DN)? Participants recruited at the participating clinical centers will undergo: * A clinical interview, during which demographic and medical history information will be collected. The dNA Scale will be administered, along with a questionnaire assessing adherence to dietary habits typical of a Mediterranean diet (14-Item Mediterranean Diet Adherence Screener; MEDAS). * A neuropsychological assessment, aimed at evaluating general cognitive function with a particular focus on episodic memory and executive functions. The following tests will be administered: Mini-Mental State Examination (MMSE) or, alternatively, Montreal Cognitive Assessment (MoCA); Rey Auditory Verbal Learning Test (RAVLT); Trial Making Test (TMT) Form B; Digit Span Forward and Backward (WAIS or WAIS-III); and the Stroop Test. * Self-report questionnaires designed to assess depressive symptoms using the Geriatric Depression Scale (GDS) and anxiety symptoms using the Geriatric Anxiety Scale (GAS) (or alternatively the State-Trait Anxiety Inventory, STAI). Finally, the Cognitive Reserve Index Questionnaire will be administered to estimate Cognitive Reserve (CRIq). * Where available, MRI data previously acquired for clinical or diagnostic purposes will be included in the study and analyzed by the principal investigator.

Eligibility Criteria

Inclusion Criteria (Stage #1): * Individuals aged ≥ 65 years residing in Italy; * Cognitively healthy individuals (HC); * Individuals with subjective memory complaints (SMC); * Individuals with mild cognitive impairment (MCI); * Individuals with probable Alzheimer's disease (AD). Inclusion criteria (Stage #2 \& Stage #3): * Individuals aged ≥ 65 years residing in Italy; * Cognitively healthy individuals (HC); * Individuals with subjective memory complaints (SMC); * Individuals with mild cognitive impairment (MCI); * Individuals with probable Alzheimer's disease (AD); * Individuals with Alzheimer's disease or other forms of dementia; * Individuals suffering from mental disorders clinically diagnosed. Cognitively healthy individuals (HC): * MMSE score ≥24, or alternatively MoCA score ≥26; * No diagnosis of depression, MCI or any form of dementia; * Episodic memory performance within the normal range (Wechsler Memory Scale Logical Memory II ≥9 for 16 years of schooling or more; ≥5 for 8-15 years of schooling, ≥3 for 0-7 years of schooling; or alternatively for Prose Memory Test with scores ≥9 for ≥16 years of schooling → ≥5 items in immediate or delayed recall; ≥5 for 8-15 years of schooling → ≥3-4 items in immediate or delayed recall; ≥3 for 0-7 years of schooling → ≥2 items in immediate or delayed recall) Individuals with Subjective Memory Complaints (SMC): * MMSE score ≥24, or alternatively MoCA score ≥26; * A significant memory impairment, reported by the subject, a family member, or the clinician; * No diagnosis of depression, MCI or any form of dementia; * Episodic memory performance within the normal range on the Wechsler Memory Scale Logical Memory II adjusted for years of schooling (≥9 for 16+ years of schooling, ≥5 for 8-15 years of schooling, ≥3 for 0-7 years of schooling) or, alternatively, on the Prose Memory Test (with scores ≥9 for ≥16 years of schooling → ≥5 items in immediate or delayed recall; ≥5 for 8-15 years of schooling → ≥3-4 items in immediate or delayed recall; ≥3 for 0-7 years of schooling → ≥2 items in immediate or delayed recall) Individuals with Mild Cognitive Impairment (MCI): * MMSE score between 19 and 23 inclusive (alternatively MoCA); * A decline in memory reported by the subject, a family member, or the clinician; * No diagnosis of depression or affected by any form of dementia, with preserved ability in activities of daily living; * Objective episodic memory loss on the Wechsler Memory Scale Logical Memory II adjusted for years of schooling. Individuals with probable Alzheimer's disease (AD): * Insidious onset with atypical course: some criteria for probable AD are met, but the onset of symptoms may have been sudden, or there is a lack of objective evidence of progressive cognitive decline; * Mixed etiology presentation: All criteria for probable AD are met, with concomitant cerebrovascular disorders, or the presence of features typical of another dementia or the evidence of other neurological disorders or non-neurological comorbidities; * A decline in performance compared to the previous level of functioning is evident, as also described by a caregiver (often a family member) * Onset with memory disturbances, defined as difficulty learning new information or recalling it; * Onset with non-mnemonic symptoms (language symptoms, particularly difficulty finding the correct words; visuospatial symptoms: perceptual deficits characterized by failure to recognize objects, people, or written words; executive symptoms: difficulties with reasoning and critical thinking); * MMSE score \< 23 (alternatively MoCA \< 25); * Objective episodic memory loss on the Wechsler Memory Scale Logical Memory II adjusted for years of schooling. Exclusion criteria (Stage #1): * Individuals aged \< 65 years; * Individuals not residing in Italy; * Individuals with depression or other psychiatric disorders; * Individuals with forms of dementia other than Alzheimer's disease.

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Source: ClinicalTrials.gov (NCT07533084). StuddyBuddy aggregates publicly available trial information.