- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT07833267
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
Tutkimuksen yleiskatsaus
Tila
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Longfei Jia
- Puhelinnumero: 13699225589
- Sähköposti: longfei@mail.ccmu.edu.cn
Opiskelupaikat
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Beijing, Kiina
- Xuanwu Hospital
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Lapsi
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Näytteenottomenetelmä
Tutkimusväestö
Patients with cognitive impairment, mood disorders, or behavioral disorders and Healthy controls
Kuvaus
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.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Havaintomallit: COHORT
- Aikanäkymät: PROSPECTIVE
Kohortit ja interventiot
Ryhmä/Kohortti |
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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). |
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Mini-Mental State Examination (MMSE)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Change in Alzheimer's Disease-Related Protein Biomarkers
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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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Yhteistyökumppanit ja tutkijat
Sponsori
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
- Synukleinopatiat
- Kaksisuuntaiset mielialahäiriöt ja niihin liittyvät häiriöt
- Aivojen sairaudet
- Keskushermoston sairaudet
- Hermoston sairaudet
- Käyttäytymisoireet
- Neurokognitiiviset häiriöt
- Kognitiohäiriöt
- Tauopatiat
- Liikkumishäiriöt
- Parkinsonin häiriöt
- Basal ganglia -taudit
- Käyttäytyminen
- Ahdistuneisuushäiriöt
- Kognitiivinen toimintahäiriö
- Alzheimerin tauti
- Masennus
- Kaksisuuntainen mielialahäiriö
- Mielialahäiriöt
- Mielenterveyshäiriöt
- Parkinsonin tauti
- Dementia
- Neurodegeneratiiviset sairaudet
Muut tutkimustunnusnumerot
- CARE
Yksittäisten osallistujien tietojen suunnitelma (IPD)
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