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

Sponsor
Neuromed IRCCS
Study ID
NCT07533084
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Accepted

Study Details

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.

Key Dates

First listed
Apr 16, 2026
Start date
Sep 30, 2026
Status verified
Jun 2026
Primary completion
Nov 27, 2027
Completion
Nov 27, 2027

Study Design

Enrollment
265 participants (estimated)

Arms

  • Arm: HC
    Healthy older adults (HC) aged ≥ 65 years residing in Italy. No diagnosis of depression, mild cognitive impairment or any form of dementia.
  • Arm: SMC
    Older adults with subjective memory complaints (SMC) aged ≥65 years, residing in Italy, who report or perceive subjective memory decline. This subjective memory complaint may occur with or without objective evidence of memory impairment and may be reported by the individual, a family member, or a clinician. Individuals with SMC should be excluded if they have a diagnosis of depression, mild cognitive impairment, or any form of dementia.
  • Arm: MCI
    Older adults diagnosed with mild cognitive impairment (MCI), aged ≥65 years and residing in Italy, characterized by subjective cognitive decline (reported by the individual, a family member, or a clinician), objective cognitive impairment (as assessed by the Wechsler Memory Scale Logical Memory II), and relatively preserved activities of daily living. Individuals with MCI should be excluded if they have a diagnosis of depression or any form of dementia.
  • Arm: AD
    Older adults diagnosed with probable Alzheimer's disease (AD), aged ≥65 years, residing in Italy. Individuals with probable AD exhibit a decline in performance compared to their previous level of functioning, as reported by a caregiver (often a family member), along with objective evidence of episodic memory impairment on the Wechsler Memory Scale Logical Memory II.

Primary Outcome Measure

Italian Validation and Factor Structure of the dynamic Neurocognitive Adaptation Scale (dNA) [ Time Frame: From enrollment until the completion of dNA scale administration at the time of enrollment. ]

Central Contacts

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