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Cognition and Affective Research in China (CARE)

20. September 2026 aktualisiert von: 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

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

3000

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Name: Longfei Jia
Telefonnummer: 13699225589
E-Mail: longfei@mail.ccmu.edu.cn

Studienorte

China
- - Beijing, China
    - Xuanwu Hospital

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

Kind
Erwachsene
Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Beobachtungsmodelle: COHORT
Zeitperspektiven: PROSPECTIVE

Anzahl der Gruppen / Kohorten

Kohorten und Interventionen

Gruppe / Kohorte
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).

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme	Maßnahmenbeschreibung	Zeitfenster
Mini-Mental State Examination (MMSE) Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme	Maßnahmenbeschreibung	Zeitfenster
Change in Alzheimer's Disease-Related Protein Biomarkers Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Xuanwu Hospital, Beijing

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Oktober 2026

Primärer Abschluss (Geschätzt)

30. Juli 2036

Studienabschluss (Geschätzt)

30. Juli 2036

Studienanmeldedaten

Zuerst eingereicht

13. September 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

20. September 2026

Zuerst gepostet (Tatsächlich)

22. September 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)