Cognition and Affective Research in China (CARE)
This is a prospective cohort study of patients with cognitive impairment mood disorders and behavioral disorders. Comprehensive baseline and longitudinal follow-up assessments include clinical and epidemiological data, cognitive function and neuropsychological assessments, laboratory measurements, and neuroimaging data, along with the collection of blood, urine, feces, and cerebrospinal fluid for biobanking. Multi-omics, multidimensional cognitive assessments, and multimodal neuroimaging data are integrated using statistical analyses to establish a comprehensive clinical database and biobank. The study aims to identify risk factors, elucidate mechanisms underlying the comorbidity of cognitive impairment and mood disorders, discover multimodal biomarkers, and improve early screening, risk prediction, and diagnosis
Descripción general del estudio
Estado
Descripción detallada
We conducted a prospective cohort study involving patients with cognitive impairment、 mood disorders and behavioral disorders .To address the challenges in the early diagnosis and intervention, comprehensive baseline assessments were conducted, including the collection of clinical and epidemiological data, cognitive function and neuropsychological assessments, laboratory measurements, and neuroimaging data. In addition, biological specimens, including blood, urine, feces, and cerebrospinal fluid, were collected and stored in a biobank for subsequent laboratory analyses. We followed participants longitudinally and repeated the comprehensive assessments at scheduled visits.. By integrating multi-omics platforms, multidimensional cognitive assessments, and multimodal neuroimaging analyses, together with statistical approaches including the chi-square test, analysis of variance (ANOVA), and logistic regression, a multidimensional cognitive impairment and affective cohort as well as a comprehensive clinical database and biobank were established. The ultimate objective is to identify risk factors for cognitive impairment and mood disorder spectrum diseases, elucidate the biological mechanisms underlying their comorbidity, identify multimodal biomarkers, and develop robust approaches for the early screening, risk prediction, and diagnosis of these disorders.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Longfei Jia
- Número de teléfono: 13699225589
- Correo electrónico: longfei@mail.ccmu.edu.cn
Ubicaciones de estudio
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Beijing, Porcelana
- Xuanwu Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Patients with cognitive impairment, mood disorders, or behavioral disorders and Healthy controls
Descripción
Inclusion Criteria:
- Participants who met the diagnostic criteria for cognitive impairment, mood disorders, behavioral disorders, or other related disorders according to the International Classification of Diseases, 11th Revision (ICD-11).
Exclusion Criteria:
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1、Participants with major organ failure (e.g., cardiac, hepatic, or renal failure), malignant tumors, or other conditions associated with a limited life expectancy that would preclude completion of the follow-up.
2、Contraindications to magnetic resonance imaging (MRI), including claustrophobia; implantation of MRI-incompatible devices or metallic implants, such as cardiac pacemakers, aneurysm clips, prosthetic heart valves, cochlear implants, or other metallic foreign bodies; or any other clinical history or examination findings that, in the investigator's judgment, may pose a potential risk during MRI examination.
3、Refusal to provide biological samples. 4、Refusal to provide written informed consent.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: PROSPECTIVE
Cohortes e Intervenciones
Grupo / Cohorte |
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Healthy controls
Healthy volunteers without cognitive impairment, mood disorders, or other major neurological or psychiatric disorders. |
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Patients with cognitive impairment
Participants who met the diagnostic criteria for cognitive impairment or other related disorders according to the International Classification of Diseases, 11th Revision (ICD-11) |
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Patients with mood disorders
Participants who met the diagnostic criteria for mood disorders,or other related disorders according to the International Classification of Diseases, 11th Revision (ICD-11). |
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Patients with behavioral disorders
Participants who met the diagnostic criteria for behavioral disorders or other related disorders according to the International Classification of Diseases, 11th Revision (ICD-11). |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Mini-Mental State Examination (MMSE)
Periodo de tiempo: Baseline, 1 years, 2years，3years and 4years
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The Mini-Mental State Examination (MMSE) is a standardized cognitive screening instrument used to assess global cognitive function, including orientation, registration, attention and calculation, recall, and language. Higher scores indicate better overall cognitive performance. |
Baseline, 1 years, 2years，3years and 4years
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Montreal Cognitive Assessment
Periodo de tiempo: Baseline, 1 years, 2years，3years and 4years
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The Montreal Cognitive Assessment (MoCA) is a standardized cognitive screening instrument used to assess multiple cognitive domains, including visuospatial and executive functions, naming, memory, attention, language, abstraction, and orientation. Higher scores indicate better overall cognitive performance |
Baseline, 1 years, 2years，3years and 4years
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Hamilton Depression Rating Scale
Periodo de tiempo: Baseline, 1 years, 2years，3years and 4years
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The Hamilton Depression Rating Scale (HAM-D) is a clinician-administered instrument used to assess the severity of depressive symptoms, including mood, somatic symptoms, sleep disturbances, and psychological symptoms. Higher scores indicate greater depressive symptom severity. |
Baseline, 1 years, 2years，3years and 4years
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Hamilton Anxiety Rating Scale
Periodo de tiempo: Baseline, 1 years, 2years，3years and 4years
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The Hamilton Anxiety Rating Scale (HAM-A) is a clinician-administered instrument used to assess the severity of anxiety symptoms, including psychological and physical symptoms of anxiety. Higher scores indicate greater anxiety symptom severity. |
Baseline, 1 years, 2years，3years and 4years
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Neuropsychiatric Inventory
Periodo de tiempo: Baseline, 1 years, 2years，3years and 4years
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The Neuropsychiatric Inventory (NPI) is a standardized instrument used to assess the presence, frequency, and severity of neuropsychiatric symptoms, including delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, aberrant motor behavior, sleep disturbances, and appetite or eating abnormalities. Higher scores indicate greater neuropsychiatric symptom burden. |
Baseline, 1 years, 2years，3years and 4years
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change in Alzheimer's Disease-Related Protein Biomarkers
Periodo de tiempo: Baseline, 1 years, 2years, 3years and 4 years
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Alzheimer's disease-related protein biomarkers, including amyloid-beta (Aβ) and tau, are measured to assess pathological changes associated with Alzheimer's disease. These biomarkers include measures of amyloid-beta and tau pathology, with higher biomarker levels indicating greater biomarker burden when applicable |
Baseline, 1 years, 2years, 3years and 4 years
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Change in Inflammatory Biomarkers
Periodo de tiempo: Baseline, 1 years, 2years，3years and 4years
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Inflammatory biomarkers, including interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-α), and C-reactive protein (CRP), are measured to assess systemic inflammatory status. Higher levels generally indicate greater inflammatory activity. |
Baseline, 1 years, 2years，3years and 4years
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Change in Structural MRI-Derived Neuroimaging Biomarkers
Periodo de tiempo: Baseline, 1 years, 2years，3years and 4years
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Structural magnetic resonance imaging (MRI)-derived neuroimaging biomarkers are used to assess brain structural characteristics, including regional brain volumes and measures of brain atrophy. These biomarkers are derived from standardized structural MRI analyses and are used to characterize longitudinal changes in brain structure. |
Baseline, 1 years, 2years，3years and 4years
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
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
- Sinucleinopatías
- Trastornos bipolares y relacionados
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Síntomas de comportamiento
- Trastornos neurocognitivos
- Trastornos cognitivos
- Tauopatías
- Trastornos del movimiento
- Trastornos Parkinsonianos
- Enfermedades de los ganglios basales
- Comportamiento
- Desórdenes de ansiedad
- Disfunción congnitiva
- Enfermedad de Alzheimer
- Depresión
- Trastorno bipolar
- Trastornos del estado de ánimo
- Desordenes mentales
- Enfermedad de Parkinson
- Demencia
- Enfermedades neurodegenerativas
Otros números de identificación del estudio
- CARE
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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