NCT07634055 Assessment of Motor Reserve in the Preclinical Stages of Dementia

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This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 200 participants in total. It began in 2026-07 with a primary completion date of 2026-09.

Brief Summary

Mild Cognitive Impairment (MCI) is a clinical condition associated with an increased risk of progression to dementia. Although cognitive alterations have traditionally been the main focus of investigation, growing evidence suggests that motor changes may also emerge during the early stages of cognitive decline and may represent potential preclinical indicators of disease. In this context, the concept of motor reserve has emerged as a construct of increasing interest, although it remains insufficiently defined. Understanding how motor characteristics may contribute to an individual's ability to compensate for or modulate the effects of cognitive decline could provide new insights into the mechanisms involved in the early stages of dementia. Therefore, the present monocentric observational study aims to further investigate the concept of motor reserve in healthy individuals and in patients with Mild Cognitive Impairment (MCI) through a multidimensional approach based on clinical, neuropsychological, behavioral, and kinematic assessments. In particular, standardized motor tasks and quantitative movement analyses using a sensor-based medical device will be employed to objectively characterize motor performance.The study plans to recruit approximately 200 participants, including healthy individuals and patients with MCI, enrolled at the Neuropsychology Outpatient Clinic of the Neurology Unit of the University Hospital "Renato Dulbecco" in Catanzaro. In the healthy group, the relationship between motor reserve and motor performance will be investigated, while in patients with MCI the relationship between cognitive reserve, motor reserve, clinical and neuropsychological status, and motor performance will be explored. The findings of this study may contribute to a broader and more operational definition of motor reserve and support the identification of potential motor biomarkers associated with early cognitive decline. These findings may ultimately contribute to the development of innovative strategies for the early detection and monitoring of conditions at risk of progression to dementia.

Eligibility Criteria

Inclusion Criteria: * Patients with Mild Cognitive Impairment (MCI) group * Diagnosis of MCI according to the international criteria of the National Institute on Aging-Alzheimer's Association (NIA-AA) (Albert et al., 2011; McKhann et al., 2011). * Age between 40 and 85 years. * Native Italian speaker or sufficient Italian language proficiency to understand the tests. * Signed informed consent provided by the participant or by a legal representative. * Healthy subjects group * Normal performance on the neuropsychological screening assessment. Age between 40 and 85 years. * Native Italian speaker or sufficient Italian language proficiency to understand the tests. * Signed informed consent. Exclusion Criteria: * Patients with Mild Cognitive Impairment (MCI) group -History of psychiatric or neurological disorders not attributable to MCI. Use of psychotropic medications. * Healthy subjects group * History of psychiatric or neurological disorders. * Use of psychotropic medications. * Disabling medical comorbidities or medical conditions interfering with motor function.

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