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

NCT07533084 | Not Yet Recruiting

• 1 other identifier: Unit of Neurology_dNA
• Study Type: observational
• Target: 265
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

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

Keywords

activities; habits; lifetime protective factors; adaptation; dynamic; neurocognitive; prevention; reserve; resilience; resistance; validation; well-being; aging

Outcome Measures

Primary Outcomes (1)

• 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).

  From enrollment until the completion of dNA scale administration at the time of enrollment.

Secondary Outcomes (3)

• Association Between Activity Engagement, Temporal Maintenance, and Educational Attainment

  From enrollment until the completion of dNA scale administration and demographic assessment at the time of enrollment.

• Association Between dNA scale and Neuropsychological Measures

  From enrollment until the completion of dNA scale administration and the neuropsychological assessment.

• Association Between dNA scale and Structural and Functional Brain Organization

  From enrollment until the completion of dNA scale administration and the neuroimaging acquisition. Structural MRI and functional MRI will be conducted at baseline if not already available from the participant registry.

Other Outcomes (1)

• Association Between dNA scale and Biomarkers of Pathological Aging

  From enrollment until the completion of dNA scale administration and retrieval of relevant information from the participant's medical record.

Study Arms (4)

HC

Healthy older adults (HC) aged ≥ 65 years residing in Italy. No diagnosis of depression, mild cognitive impairment or any form of dementia.

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.

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.

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.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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).

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS National Neurological Institute "C. Mondino" Foundation: collaborator
• Neuromed IRCCS: lead
• Istituto ricerca carattere Scientifico Fatebenefratelli Brescia: 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

Study Sites (8)

IRCCS Centro San Giovanni di Dio Fatebenefratelli

Brescia, BS, 25125, Italy

Location

IRCCS San Martino

Genova, GE, 16132, Italy

Location

IRCCS Neuromed - Istituto Neurologico Mediterraneo

Pozzilli, IS, 86077, Italy

Location

IRCCS Ospedale San Raffaele

Milan, Michigan, 20132, Italy

Location

IRCCS Istituto Neurologico Carlo Besta

Milan, Michigan, 20133, Italy

Location

IRCCS Fondazione Mondino

Pavia, PV, 27100, Italy

Location

IRCCS Campus Bio-Medico

Roma, RM, 00128, Italy

Location

IRCCS Ospedale San Camillo

Venezia, VE, 30126, Italy

Location

Related Publications (4)

• Wang J, Wang X, Xia M, Liao X, Evans A, He Y. GRETNA: a graph theoretical network analysis toolbox for imaging connectomics. Front Hum Neurosci. 2015 Jun 30;9:386. doi: 10.3389/fnhum.2015.00386. eCollection 2015.

  PMID: 26175682 BACKGROUND

• Tzourio-Mazoyer N, Landeau B, Papathanassiou D, Crivello F, Etard O, Delcroix N, Mazoyer B, Joliot M. Automated anatomical labeling of activations in SPM using a macroscopic anatomical parcellation of the MNI MRI single-subject brain. Neuroimage. 2002 Jan;15(1):273-89. doi: 10.1006/nimg.2001.0978.

  PMID: 11771995 BACKGROUND

• Cieri F, Di Francesco G, Cross CL, Bender A, Caldwell JZK. Dynamic neurocognitive adaptation in aging: Development and validation of a new scale. Alzheimers Dement (N Y). 2025 Jan 20;11(1):e70049. doi: 10.1002/trc2.70049. eCollection 2025 Jan-Mar.

  PMID: 39839075 BACKGROUND

• White M. Sample size in quantitative instrument validation studies: A systematic review of articles published in Scopus, 2021. Heliyon. 2022 Dec 12;8(12):e12223. doi: 10.1016/j.heliyon.2022.e12223. eCollection 2022 Dec.

  PMID: 36568672 BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction; Dementia; Alzheimer Disease; Motor Activity; Habits

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Behavior

Study Officials

• Luana Dr Gilio

  Neuromed IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luana Dr Gilio

CONTACT

+393404757480; gilio.luana@gmail.com

Direzione Scientifica IRCCS Neuromed

CONTACT

+390865915217; direzionescientifica@neuromed.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychologist, Psychotherapist, PhD, Researcher in Neuropsychology and Cognitive Neuroscience

Study Record Dates

• First Submitted: April 9, 2026
• First Posted: April 16, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): November 27, 2027
• Study Completion (Estimated): November 27, 2027
• Last Updated: June 11, 2026

Record last verified: 2026-06

Locations

IT (8)