このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。英語版ソーステキスト用。

Cognition and Affective Research in China (CARE)

2026年9月20日更新者：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

調査の概要

状態

まだ募集していません

条件

詳細な説明

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.

研究の種類

観察的

入学 (推定)

3000

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

名前：Longfei Jia
電話番号：13699225589
メール：longfei@mail.ccmu.edu.cn

研究場所

中国
- - Beijing、中国
    - Xuanwu Hospital

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

子
大人
高齢者

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

サンプリング方法

非確率サンプル

調査対象母集団

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

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

観測モデル：COHORT
時間の展望：PROSPECTIVE

グループ/コホートの数

コホートと介入

グループ/コホート
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).

この研究は何を測定していますか？

主要な結果の測定

結果測定	メジャーの説明	時間枠
Mini-Mental State Examination (MMSE) 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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

二次結果の測定

結果測定	メジャーの説明	時間枠
Change in Alzheimer's Disease-Related Protein Biomarkers 時間枠：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 時間枠：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 時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Xuanwu Hospital, Beijing

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年10月1日

一次修了 (推定)

2036年7月30日

研究の完了 (推定)

2036年7月30日

試験登録日

最初に提出

2026年9月13日

QC基準を満たした最初の提出物

2026年9月20日

最初の投稿 (実際)

2026年9月22日

学習記録の更新

投稿された最後の更新 (実際)