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Sponsor: Neuromed IRCCS
Conditions: Active Aging Individuals Aged 65 and Over, Aging, Mild Cognitive Impairment (MCI), Dementia, Dementia Alzheimer Type
Countries: Italy
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.
Sex: ALL
Age: 65 Years to —
Healthy volunteers: Yes
Study type: OBSERVATIONAL
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.
- Brescia, BS, Italy
- Genova, GE, Italy
- Pozzilli, IS, Italy
- Milan, Michigan, Italy
- Milan, Michigan, Italy
- Pavia, PV, Italy
- Roma, RM, Italy
- Venezia, VE, Italy