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NCT07533084Not yet recruiting

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

Italian Validation of the Dynamic Neurocognitive Adaptation (dNA) Scale and Its Correlation With Neurocognitive Variables

Source: ClinicalTrials.gov · Last updated 11 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
265 (estimated)
First submitted
9 Apr 2026
Start date
1 Sept 2026
Primary completion date
27 Nov 2027
Lead sponsor
Neuromed IRCCS
NCT number
NCT07533084

What you commit to

  • Study type: Observational
  • Planned participants: 265
  • From 1 Sept 2026 to the primary completion date, 27 Nov 2027
  • 8 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Individuals with depression or other psychiatric disorders;
  • Individuals with forms of dementia other than Alzheimer's disease.

Age

  • Individuals aged \< 65 years;

Other

  • Individuals not residing in Italy;

Who the study is looking for

  • 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 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.

Age in the registry: 65 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (8)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
IRCCS Centro San Giovanni di Dio Fatebenefratelli
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BresciaItalyUnknown status
IRCCS San Martino
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GenovaItalyUnknown status
IRCCS Ospedale San Raffaele
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MilanItalyUnknown status
IRCCS Istituto Neurologico Carlo Besta
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MilanItalyUnknown status
IRCCS Fondazione Mondino
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PaviaItalyUnknown status
IRCCS Neuromed - Istituto Neurologico Mediterraneo
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PozzilliItalyUnknown status
IRCCS Campus Bio-Medico
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RomaItalyUnknown status
IRCCS Ospedale San Camillo
Coordinator of this site? Confirm its status
VeneziaItalyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.