Assessment of Motor Reserve in the Preclinical Stages of Dementia

NCT07634055 | Recruiting

• 1 other identifier: 114/2026
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment (MCI)

Keywords

mci; mild cognitive impairment; Healthy populations; motor reserve; Motor biomarkers; Kinematic assessment

Outcome Measures

Primary Outcomes (1)

• Finger Tapping Metrics

  Motor performance is assessed using a sensor-engineered glove that records the contact events between the thumb and the four fingers (index, middle, ring, little) on each hand independently, providing finger-level timing parameters for each sequence of taps.

  Baseline (single assessment)

Study Arms (2)

*Patients with MCI*

Device: Sensor-based medical device for kinematic assessment: Hand Test System (HTS)

Healthy Controls

Device: Sensor-based medical device for kinematic assessment: Hand Test System (HTS)

Interventions

Sensor-based medical device for kinematic assessment: Hand Test System (HTS) DEVICE

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 its relationship with cognitive reserve, clinical status, and neuropsychological functioning. No therapeutic intervention or experimental treatment will be administered. All procedures will be performed exclusively for observational research purposes.

*Patients with MCI*; Healthy Controls

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of approximately 200 participants divided into two groups: 100 patients with Mild Cognitive Impairment (MCI) and 100 healthy control subjects. Participants will be recruited at the Neuropsychology Outpatient Clinic of the Neurology Unit, University Hospital "Renato Dulbecco", Pugliese Hospital, Catanzaro, Italy. MCI patients will be included according to international NIA-AA diagnostic criteria, while healthy subjects must show normal performance on neuropsychological screening. All participants will undergo clinical, anamnestic, and neuropsychological evaluation, followed by motor reserve assessment and kinematic evaluation at the IBSBC-CNR laboratories in Catanzaro using standardized motor tasks and a CE-marked sensor glove medical device. Written informed consent will be obtained from all participants or a legal representative, when applicable.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituto per la Ricerca e l'Innovazione Biomedica: lead
• Azienda Ospedaliera Universitaria Renato Dulbecco: collaborator

Study Sites (1)

Azienda Ospedaliera "Renato Dulbecco"

Catanzaro, Catanzaro, 88100, Italy

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction; Neurocognitive Disorders

Condition Hierarchy (Ancestors)

Cognition Disorders; Mental Disorders

Central Study Contacts

Domenico co Bosco, Medical Doctor

CONTACT

0961/883021; nico.bosco@libero.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department of Biomedical Sciences, CNR, Roma

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: June 8, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: June 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)