NCT07533084 · NOT YET RECRUITING

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

This Italian study is testing a questionnaire, not a drug or treatment. The dNA Scale asks about past and current physical, cognitive, creative, and social activity. Researchers want to see whether higher scores line up with memory, thinking tests, and brain connectivity on MRI in about 265 older adults. No phase applies, since nothing is being given to participants.

Eligibility criteria

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.

The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.

Eligibility criteria as of 2026-06-11

View full record on ClinicalTrials.gov

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