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Cognition and Affective Research in China (CARE)

20 de setembro de 2026 atualizado por: Xuanwu Hospital, Beijing

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

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Descrição detalhada

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 estudo

Observacional

Inscrição (Estimado)

3000

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Nome: Longfei Jia
Número de telefone: 13699225589
E-mail: longfei@mail.ccmu.edu.cn

Locais de estudo

China
- - Beijing, China
    - Xuanwu Hospital

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

Filho
Adulto
Adulto mais velho

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra Não Probabilística

População do estudo

Patients with cognitive impairment, mood disorders, or behavioral disorders and Healthy controls

Descrição

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:

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Modelos de observação: COHORT
Perspectivas de Tempo: PROSPECTIVE

Número de grupos/coortes

Coortes e Intervenções

Grupo / Coorte
Healthy controls Healthy volunteers without cognitive impairment, mood disorders, or other major neurological or psychiatric disorders.
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)
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).
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).

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado	Descrição da medida	Prazo
Mini-Mental State Examination (MMSE) Prazo: Baseline, 1 years, 2years，3years and 4years	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
Montreal Cognitive Assessment Prazo: Baseline, 1 years, 2years，3years and 4years	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
Hamilton Depression Rating Scale Prazo: Baseline, 1 years, 2years，3years and 4years	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
Hamilton Anxiety Rating Scale Prazo: Baseline, 1 years, 2years，3years and 4years	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
Neuropsychiatric Inventory Prazo: Baseline, 1 years, 2years，3years and 4years	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

Medidas de resultados secundários

Medida de resultado	Descrição da medida	Prazo
Change in Alzheimer's Disease-Related Protein Biomarkers Prazo: Baseline, 1 years, 2years, 3years and 4 years	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
Change in Inflammatory Biomarkers Prazo: Baseline, 1 years, 2years，3years and 4years	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
Change in Structural MRI-Derived Neuroimaging Biomarkers Prazo: Baseline, 1 years, 2years，3years and 4years	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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Xuanwu Hospital, Beijing

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de outubro de 2026

Conclusão Primária (Estimado)

30 de julho de 2036

Conclusão do estudo (Estimado)

30 de julho de 2036

Datas de inscrição no estudo

Enviado pela primeira vez

13 de setembro de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

20 de setembro de 2026

Primeira postagem (Real)

22 de setembro de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)