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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65+
SponsorNeuromed IRCCS

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

Qualifiers

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 design

Treatments tested in this trial

  • Not listed

Trial groups

265 Participants
are grouped into 4 trial groups

Sponsors and collaborators

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