Neurodegenerative DiseaseCARENCT07833267
Cognition and Affective Research in China
An observational study of Neurodegenerative Disease and Dementia, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Neurodegenerative Disease, Dementia, Alzheimer's Disease
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2026to 30 Jul 2036
- How long will I take part?
- 4 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients with cognitive impairment, mood disorders, or behavioral disorders and Healthy controls
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
Read the detailed description
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.
- Conditions
- Neurodegenerative Disease, Dementia, Alzheimer's Disease, Parkinson's Disease, Mood Disorders, Depression
- Keywords
- cognitive impairment, mood disorders, behavioral disorders, Neuropsychological Assessment, Biomarkers
- Medical subject headings
- Neurodegenerative Diseases, Dementia, Alzheimer Disease, Parkinson Disease, Mood Disorders, Depression, Anxiety Disorders, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 1 years, 2years，3years and 4years
Secondary outcomes (3)
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
Measured: Baseline, 1 years, 2years, 3years and 4 years
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.
Measured: Baseline, 1 years, 2years，3years and 4years
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.
Measured: Baseline, 1 years, 2years，3years and 4years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion30 Jul 2036 (estimated)
- Study completion30 Jul 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurodegenerative DiseaseStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07833267
- Sponsor's protocol ID
- CARE
- Acronym
- CARE
- Status last verified
- Sep 2026
- First submitted
- 13 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognition and Affective Research in China
- ClinicalTrials.gov ID
- NCT07833267
- Acronym / sponsor ID
- CARE / CARE
- Conditions
- Neurodegenerative Disease, Dementia, Alzheimer's Disease, Parkinson's Disease, Mood Disorders, Depression
- Keywords
- cognitive impairment, mood disorders, behavioral disorders, Neuropsychological Assessment, Biomarkers
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 30 Jul 2036 (estimated)
- Study completion
- 30 Jul 2036 (estimated)
- First posted
- 22 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with cognitive impairment, mood disorders, or behavioral disorders and Healthy controls
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mini-Mental State Examination (MMSE)
Time frame: 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.
Montreal Cognitive Assessment
Time frame: 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
Hamilton Depression Rating Scale
Time frame: 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.
Hamilton Anxiety Rating Scale
Time frame: 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.
Neuropsychiatric Inventory
Time frame: 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.
3 secondary outcomes
Change in Alzheimer's Disease-Related Protein Biomarkers
Time frame: Baseline, 1 years, 2years, 3years and 4 years
Change in Inflammatory Biomarkers
Time frame: Baseline, 1 years, 2years，3years and 4years
Change in Structural MRI-Derived Neuroimaging Biomarkers
Time frame: Baseline, 1 years, 2years，3years and 4years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurodegenerative Disease and Dementia, run by Xuanwu Hospital, Beijing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Longfei Jia (13699225589, longfei@mail.ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mini-Mental State Examination (MMSE) (time frame: Baseline, 1 years, 2years，3years and 4years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.