Italian Validation of the Dynamic Neurocognitive Adaptation (dNA) Scale and Its Correlation With Neurocognitive Variables
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 265
- Locations
- 8
- Primary Endpoint
- Italian Validation and Factor Structure of the dynamic Neurocognitive Adaptation Scale (dNA)
Study Overview
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.
Detailed Description
This study aims to validate the instrument known as the dynamic Neurocognitive Adaptation Scale (dNA), derived from the identical scale previously validated in English on a sample of 815 subjects residing in the United States. All the clinical centers involved will recruit approximately 265 subjects, administer the aforementioned scale, and collect demographic and medical history information. This information will be necessary and sufficient for the first part (Stage #1) of the instrument's validation. Actually, according to the literature, the number of participants required to validate a scale with 20 items- which has already been validated in another language-is approximately 250 participants. Other studies suggest a minimum of 200 subjects to test cross-cultural consistency and reliability. The dNA scale, already validated in English, reports a KM O index greater than .80 (i.e., good), a specific index (Kaiser-Meyer-Olkin) for confirming the appropriateness of the sample. Specifically, for the CFA, this sample size calculation accounts for the need to detect a medium effect size, expressed in terms of Root Mean Square Error of Approximation (RMSEA), with an expected value of 0.05, a statistical power (1-β) of 0.80, and a significance level α of 0.05. Taking potential dropouts into account, approximately 265 subjects will be recruited to ensure the minimum sample size required for statistical power, and this number will be verified experimentally during the validation phase using the KMO index.
Each of the 8 participating centers, depending on their recruitment capacity, will enroll approximately at least 30 participants. The majority of the final sample (i.e., 265 participants) will consist of healthy older adults (HC), while a smaller percentage will include subjects with subjective memory complaints (SMC), mild cognitive impairment (MCI), or Alzheimer's disease (AD).
The first phase (Stage #1) will be followed by a second part (Stage #2) focused on exploring the correlation between the dNA score and neuropsychological variables (particularly those related to memory and executive functions), with the aim of investigating a measure of adaptation that is primarily cognitive in nature. This adaptation will provide a measure of cognitive efficiency, commonly referred to in the literature as cognitive reserve or resilience. In this phase, adherence to a Mediterranean-style diet (i.e., the Mediterranean diet, assessed via a specific questionnaire) will also be explored as a protective factor against general inflammatory processes and cognitive decline associated with Alzheimer's disease (AD).
During the third phase (Stage #3), a measure of neural adaptation will be explored, collecting data on neural efficiency. In the literature, this is a form of resilience or adaptation often described as neural reserve. This component will be explored using structural magnetic resonance imaging (MRI) and functional magnetic resonance imaging (fMRI).
Demographic information, medical history, dietary habits, and neuropsychological data collected by the participating centers will be compiled and managed at the Universities of Chieti and Foggia, under the coordination and responsibility of Professor Michela Balsamo (CH) and Professor Leonardo Carlucci (FG), respectively, both of whom have established expertise in statistics and psychometrics, particularly in the validation of instruments within the field of psychology. The two universities will carry out the data analysis phase aimed at validating the scale (Stage #1), also accounting for key demographic variables (age, sex, education level).
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •(Stage #1):
- •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).
- •Inclusion criteria (Stage #2 & Stage #3):
- •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.
Exclusion Criteria
- •(Stage #1):
- •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.
Arms & Interventions
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.
Outcomes
Primary Outcomes
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.
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 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.)
- 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.)
Investigators
Luana Gilio
Psychologist, Psychotherapist, PhD, Researcher in Neuropsychology and Cognitive Neuroscience
Neuromed IRCCS