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Recruiting NCT07634055

Assessment of Motor Reserve in the Preclinical Stages of Dementia

Observational Mild Cognitive Impairment (MCI)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sensor-based medical device for kinematic assessment: Hand Test System (HTS).
Who it may be relevant to
Registry conditions: Mild Cognitive Impairment (MCI). Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Assessment of Motor Reserve in the Preclinical Stages of Dementia.

Overview

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.

Interventions

  • Device Sensor-based medical device for kinematic assessment: Hand Test System (HTS)
    Participants will undergo a multidimensional assessment protocol aimed at investigating motor reserve in healthy individuals and patients with (MCI). The assessment will include clinical and neuropsychological evaluations, standardized motor tasks, and quantitative kinematic movement analysis using a sensor glove classified as a medical device, designed to record objective motor parameters during task execution. The collected measures will be used to characterize motor performance and to analyze

Primary outcome measures

  • Finger Tapping Metrics [Time frame: Baseline (single assessment)]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

Italy · 1 center
  • Azienda Ospedaliera "Renato Dulbecco" — Catanzaro

Identifiers

NCT: NCT07634055 · 114/2026

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗