- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Domenico co Bosco, Medical Doctor
- Número de teléfono: 0961/883021
- Correo electrónico: nico.bosco@libero.it
Ubicaciones de estudio
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Catanzaro
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Catanzaro, Catanzaro, Italia, 88100
- Reclutamiento
- Azienda Ospedaliera "Renato Dulbecco"
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Contacto:
- Domenico Bosco, Medical Doctor
- Número de teléfono: 0961/883021
- Correo electrónico: nico_bosco@libero.it
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
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Controles saludables
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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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Finger Tapping Metrics
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
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Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 114/2026
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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