Cognition and Affective Research in China

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorXuanwu Hospital, Beijing

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

3,000 Participants
are grouped into 4 trial groups
Group A: Healthy controls
Group B: Patients with cognitive impairment
Group C: Patients with mood disorders
Group D: Patients with behavioral disorders

Trial outcomes

Primary outcomes

1

Mini-Mental State Examination (MMSE)

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.

Time frame
Baseline, 1 years, 2years,3years and 4years
2

Montreal Cognitive Assessment

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

Time frame
Baseline, 1 years, 2years,3years and 4years
3

Hamilton Depression Rating Scale

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.

Time frame
Baseline, 1 years, 2years,3years and 4years
4

Hamilton Anxiety Rating Scale

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.

Time frame
Baseline, 1 years, 2years,3years and 4years

Secondary outcomes

1

Change in Alzheimer's Disease-Related Protein Biomarkers

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

Time frame
Baseline, 1 years, 2years, 3years and 4 years
2

Change in Inflammatory Biomarkers

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.

Time frame
Baseline, 1 years, 2years,3years and 4years
3

Change in Structural MRI-Derived Neuroimaging Biomarkers

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.

Time frame
Baseline, 1 years, 2years,3years and 4years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: