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Cognition and Affective Research in China (CARE)

20 września 2026 zaktualizowane przez: 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

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Szczegółowy opis

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.

Typ studiów

Obserwacyjny

Zapisy (Szacowany)

3000

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Nazwa: Longfei Jia
Numer telefonu: 13699225589
E-mail: longfei@mail.ccmu.edu.cn

Lokalizacje studiów

Chiny
- - Beijing, Chiny
    - Xuanwu Hospital

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

Dziecko
Dorosły
Starszy dorosły

Akceptuje zdrowych ochotników

Tak

Płeć kwalifikująca się do nauki

Wszystko

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

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

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Modele obserwacyjne: COHORT
Perspektywy czasowe: PROSPECTIVE

Liczba grup / kohort

Kohorty i interwencje

Grupa / Kohorta
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).

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku	Opis środka	Ramy czasowe
Mini-Mental State Examination (MMSE) Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku	Opis środka	Ramy czasowe
Change in Alzheimer's Disease-Related Protein Biomarkers Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Xuanwu Hospital, Beijing

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 października 2026

Zakończenie podstawowe (Szacowany)

30 lipca 2036

Ukończenie studiów (Szacowany)

30 lipca 2036

Daty rejestracji na studia

Pierwszy przesłany

13 września 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

20 września 2026

Pierwszy wysłany (Rzeczywisty)

22 września 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)