- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07634055
Assessment of Motor Reserve in the Preclinical Stages of Dementia
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.
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.
Przegląd badań
Status
Interwencja / Leczenie
Typ studiów
Zapisy (Szacowany)
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Domenico co Bosco, Medical Doctor
- Numer telefonu: 0961/883021
- E-mail: nico.bosco@libero.it
Lokalizacje studiów
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Catanzaro
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Catanzaro, Catanzaro, Włochy, 88100
- Rekrutacyjny
- Azienda Ospedaliera "Renato Dulbecco"
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Kontakt:
- Domenico Bosco, Medical Doctor
- Numer telefonu: 0961/883021
- E-mail: nico_bosco@libero.it
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Metoda próbkowania
Badana populacja
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
Interwencja / Leczenie |
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Zdrowe kontrole
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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.
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*Patients with MCI*
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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.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Finger Tapping Metrics
Ramy czasowe: Baseline (single assessment)
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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.
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Baseline (single assessment)
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Współpracownicy i badacze
Współpracownicy
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 114/2026
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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