About this trial
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
This trial accepts healthy volunteersQualifiers
Individuals aged ≥ 65 years residing in Italy;
Cognitively healthy individuals (HC);
Individuals with subjective memory complaints (SMC);
Individuals with mild cognitive impairment (MCI);
Disqualifiers
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.
Trial population
Each of the 8 participating centers will enroll approximately at least 30 participants, specifically: * IRCCS Campus Biomedico (RM): HC, AD, MCI, SMC (approximately 5 HC, 15 patients); * IRCCS Centro San Giovanni di Dio Fatebenefratelli (BS): HC, SMC (approximately 20 HC, 10 patients); * IRCCS Fondazione Mondino (PV): HC, AD, MCI, SMC (approximately 10 HC, 40 patients); * IRCCS "Carlo Besta" Neurological Institute (MI): HC, MCI (approximately 15 HC, 15 patients); * IRCCS Neuromed (IS): HC, AD, MCI, SMC (approximately 10 HC, 20 patients); * IRCCS San Camillo Hospital (VE): HC (approximately 30 HC); * IRCCS San Raffaele Hospital (MI): HC, AD, MCI, SMC (approximately 10 HC, 20 patients); * IRCCS San Martino (GE): HC, AD, MCI, SMC (approximately 10 HC, 25 patients).
Trial design
Cohort
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Italian Validation and Factor Structure of the dynamic Neurocognitive Adaptation Scale (dNA)
The primary outcome of this study is the successful Italian validation of the dNA scale. Specifically, investigators expect to replicate the results of the English-language version (Cieri et al., accepted), with a four-factor structure, no multicollinearity (r \< 0.95) or insufficient common variance (r \< 0.3), satisfactory Kaiser-Meyer-Olkin (KMO) indices (\>0.70), significant Bartlett's sphericity test (\<0.01), and high internal consistency as indicated by Cronbach's alpha (\>0.80).
Secondary outcomes
Association Between Activity Engagement, Temporal Maintenance, and Educational Attainment
Investigators expect that greater engagement in the activities under investigation, as well as their dynamic maintenance over time, reflected in higher dNA scale scores, will be positively associated with higher educational attainment.
Association Between dNA scale and Neuropsychological Measures
Investigators expect that higher dNA scale scores will be positively associated with better neuropsychological performance, particularly in episodic memory and executive function domains. Specifically, cognitive performance will be assessed using a standardized battery, including the MMSE (or MoCA) for global cognition, Rey Auditory Verbal Learning Test (RAVLT) for verbal long-term memory, Trial Making Test (TMT) Form B for executive functioning, Digits Forward and Backward subtests (WAIS or WAIS-III) for working memory, Wechsler Memory Scale Logical Memory II (or Prose Memory), and Stroop Test for cognitive inhibition and information processing speed. These measures will provide both an overall cognitive assessment and domain-specific outcomes, which will be further explored for their expected association with the dNA scale scores.
Association Between dNA scale and Structural and Functional Brain Organization
This outcome measure evaluates the relationship between dNA scale scores and functional brain network activity and organization derived from functional magnetic resonance imaging (fMRI). Within diagnostic groups (SMC, MCI, AD), higher scores on the dNA scale are hypothesized to be associated with increased activation and greater functional segregation within the task-negative network (default network, DN), alongside greater deactivation in task-positive networks, including the dorsal attention network (DAN) and the frontoparietal control network (FPCN). Functional connectivity analyses will be used to quantify both within-network segregation and between-network integration. These neuroimaging-derived metrics will be statistically associated with dNA scale scores using appropriate regression models within each diagnostic group.
Other outcomes
Association Between dNA scale and Biomarkers of Pathological Aging
This additional outcome measure will evaluate the relationship between dNA scale scores and previously collected biomarkers, contingent upon data availability. Indeed, participating centers that have the capability may also retrieve information from the participant's medical record regarding biomarkers of pathological aging (e.g., APoE). Potential association between dNA scale scores and previously collected biomarkers will be further explored, within the healthy elderly sample and each diagnostic group (SMC, MCI, AD).
Sponsors and contacts
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Neuromed IRCCS
Lead sponsor
Istituto ricerca carattere Scientifico Fatebenefratelli Brescia
Collaborator
IRCCS National Neurological Institute "C. Mondino" Foundation
Collaborator
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Collaborator
IRCCS San Camillo, Venezia, Italy
Collaborator
IRCCS Ospedale San Raffaele
Collaborator
Campus Biomedico - Roma
Collaborator
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
Collaborator
Università degli Studi 'G. d'Annunzio' Chieti e Pescara
Collaborator
University of Foggia
Collaborator
University of Padova
Collaborator
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