Cognition and Affective Research in China

NCT07833267 | Not Yet Recruiting DMC

• 1 other identifier: CARE
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Neurodegenerative Disease; Dementia; Alzheimer's Disease; Parkinson's Disease; Mood Disorders; Depression; Anxiety Disorder; Bipolar Disorder; Behavior Disorders

Keywords

cognitive impairment; mood disorders; behavioral disorders; Neuropsychological Assessment; Biomarkers

Outcome Measures

Primary Outcomes (5)

• 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.

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

• 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

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

• 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.

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

• 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.

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

• Neuropsychiatric Inventory

  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

Secondary Outcomes (3)

• Change in Alzheimer's Disease-Related Protein Biomarkers

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

• Change in Inflammatory Biomarkers

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

• Change in Structural MRI-Derived Neuroimaging Biomarkers

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

Study Arms (4)

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).

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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).

You may not qualify if:

• 、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.
• 、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.
• 、Refusal to provide biological samples. 4、Refusal to provide written informed consent.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital

Beijing, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood, urine, feces, and cerebrospinal fluid

MeSH Terms

Conditions

Neurodegenerative Diseases; Dementia; Alzheimer Disease; Parkinson Disease; Mood Disorders; Depression; Anxiety Disorders; Bipolar Disorder; Mental Disorders; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Nervous System Diseases; Brain Diseases; Central Nervous System Diseases; Neurocognitive Disorders; Tauopathies; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Behavioral Symptoms; Behavior; Bipolar and Related Disorders; Cognition Disorders

Central Study Contacts

Longfei Jia

CONTACT

13699225589; longfei@mail.ccmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2026
• First Posted: September 22, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): July 30, 2036
• Study Completion (Estimated): July 30, 2036
• Last Updated: September 22, 2026

Record last verified: 2026-09

Locations

CN (1)