Mild Cognitive Impairment (MCI)NCT07634055
Assessment of Motor Reserve in the Preclinical Stages of Dementia
An observational study of Mild Cognitive Impairment (MCI), run by Istituto per la Ricerca e l'Innovazione Biomedica at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment (MCI)
- What is being tested?
- Sensor-based medical device for kinematic assessment: Hand Test System (HTS)
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2026to Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Azienda Ospedaliera "Renato Dulbecco"
Catanzaro, Catanzaro, 88100
Domenico Bosco, Medical Doctor, 0961/883021, nico_bosco@libero.it
About this study
Official title: Assessment of Motor Reserve in the Preclinical Stages of Dementia.
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.
Read more
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)
- Being tested
- Sensor-based medical device for kinematic assessment: Hand Test System (HTS)
- Keywords
- mci, mild cognitive impairment, Healthy populations, motor reserve, Motor biomarkers, Kinematic assessment
- Medical subject headings
- Cognitive Dysfunction, Neurocognitive Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| *Patients with MCI* | Not described Receives: Device: Sensor-based medical device for kinematic assessment: Hand Test System (HTS) | |
| Healthy Controls | Not described Receives: Device: Sensor-based medical device for kinematic assessment: Hand Test System (HTS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (single assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study startJul 2026 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive Impairment (MCI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto per la Ricerca e l'Innovazione Biomedica
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Ospedaliera Universitaria Renato Dulbecco
- Responsible party
- Principal investigator, Antonio Cerasa, Istituto per la Ricerca e l'Innovazione Biomedica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07634055
- Sponsor's protocol ID
- 114/2026
- Status last verified
- Jun 2026
- First submitted
- 21 May 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vagni D, Principe E, Pirrotta M, Catalano L, Milasi C, De Francesco M, Giustiniani A, Arena C, Scarfone F, Quartarone A, Bosco D, Pioggia G, Cerasa A. Behavioral markers of motor reserve: stability, lateralization, and consistency. Front Aging Neurosci. 2026 Sep 30;18:1921302. doi: 10.3389/fnagi.2026.1921302. eCollection 2026.
PubMed 42876727
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Motor Reserve in the Preclinical Stages of Dementia.
- ClinicalTrials.gov ID
- NCT07634055
- Acronym / sponsor ID
- 114/2026
- Conditions
- Mild Cognitive Impairment (MCI)
- Keywords
- mci, mild cognitive impairment, Healthy populations, motor reserve, Motor biomarkers, Kinematic assessment
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Istituto per la Ricerca e l'Innovazione BiomedicaUniversity, hospital or other
- Collaborators
- Azienda Ospedaliera Universitaria Renato Dulbecco
- Study start
- Jul 2026 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 8 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| *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) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- Patients with Mild Cognitive Impairment (MCI) group
- Healthy subjects group
Key exclusion criteria (6 listed)
- Patients with Mild Cognitive Impairment (MCI) group
- -History of psychiatric or neurological disorders not attributable to MCI. Use of psychotropic medications.
- Healthy subjects group
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 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. | Device | *Patients with MCI*, Healthy Controls |
Primary outcome
Finger Tapping Metrics
Time frame: Baseline (single assessment)
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Derived from this study: PubMed 42876727Vagni D, Principe E, Pirrotta M, Catalano L, Milasi C, De Francesco M, Giustiniani A, Arena C, Scarfone F, Quartarone A, Bosco D, Pioggia G, Cerasa A. Behavioral markers of motor reserve: stability, lateralization, and consistency. Front Aging Neurosci. 2026 Sep 30;18:1921302. doi: 10.3389/fnagi.2026.1921302. eCollection 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mild Cognitive Impairment (MCI), run by Istituto per la Ricerca e l'Innovazione Biomedica at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Domenico co Bosco, Medical Doctor (0961/883021, nico.bosco@libero.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Finger Tapping Metrics (time frame: Baseline (single assessment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07634055, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.