BiomarkersNCT06419101
Exploring the Diagnostic Biomarkers of Cognitive Disorders in China
An observational study of Biomarkers and Dementia, run by Cuibai Wei，Clinical Professor at 1 site in China.
Trial summary
Dementia is a syndrome characterized by progressive global cognitive impairment that impairs occupational, family, or social functioning. It detrimentally affects personal health and quality of life, imposing significant medical economy, social and psychological burden on the countries and the patients' family. Read more about this study
- Who is it for?
- Ages 40 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Biomarkers, Dementia
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- 30 May 2024to 10 May 2035
- 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 40 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This project will enroll about 3000 patients with dementia, who meet the inclusion and exclusion criteria, including subjective cognitive decline (SCD), MCI, AD, frontotemporal dementia (FTD), dementia with Lewy bodies (DLB), etc.
Who may be able to join
- Male or female patients aged ≥40 and ≤90years;
- Chief complaint or others describe a cognitive decline;
- Ability to communicate in Chinese;
- The patients and their families were informed and signed the informed consent.
Who cannot join
- MMSE<10;
- There are other neurological diseases that can cause brain dysfunction (such as depression, brain tumors, Parkinson's disease, metabolic encephalopathy, encephalitis, multiple sclerosis, epilepsy, traumatic brain injury, normal intracranial pressure hydrocephalus, etc.);
- There are other systemic diseases that can cause cognitive impairment (such as hepatic insufficiency, renal insufficiency, Thyroid dysfunction, severe anemia, folic acid or vitamin B12 deficiency, syphilis, HIV infection, alcohol and drug abuse, etc.);
- Suffering from a disease that cannot cooperate with the completion of cognitive examination;
- There are contraindications to nuclear magnetic resonance;
- There is mental and neurodevelopmental delay;
- Refuse to draw blood;
- Refuse to sign the 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.
China1 site, 1 recruiting
- Recruiting
Capital Medical University Xuanwu Hospital
Beijing
Cuibai Wei, Ph.D
About this study
Official title: Cohort Study on Biomarkers of Cognitive Disorders in China
Dementia is a syndrome characterized by progressive global cognitive impairment that impairs occupational, family, or social functioning. It detrimentally affects personal health and quality of life, imposing significant medical economy, social and psychological burden on the countries and the patients' family. The internationally renowned dementia cohort includes the DIAN that focused on genetics studies, the ADNI cohort featuring imaging and the FINGERS cohort focused on risk factor intervention, etc. Establishing standardized and shared longitudinal follow-up dementia cohorts and clinical database is an essential challenge for constructing dementia cohort in China. Moreover, there is a lack of large-scale prospective longitudinal follow-up cohorts within the Chinese population that cover subjective cognitive decline (SCD) to explore biomarkers with diagnostic and early warning value for different kinds of dementia and pre-dementia stages. The study will rely on the dementia cohort based on Chinese population to explore the biological phenotype characteristics of the pre-dementia stage and different dementia subtypes, and observe the dynamic change rules of the dementia cohort vertically, so as to foster early intervention and improve prognosis for individuals with dementia.
Read the detailed description
The 3000 patients with pre-dementia stage and different dementia subtypes will be enrolled in this study, and data will be collected in the baseline including demographics, clinical symptoms, assessment of neuropsychology, neuroimaging, neuroelectrophysiology, blood samples, cerebrospinal fluid, etc. The changes of these data were dynamically observed through an annual follow-up. According to the neuropsychological evaluation results of follow-up, the subjects were divided into dementia progression (dementia-P) and dementia stabilization (dementia-S). Difference in clinical phenotype, neuropsychology, electrophysiology, neuroimaging, and body fluid multi-omics indicators between the two subtypes were compared and analyzed. The neuropsychological testes in patients with dementia included some neuropsychological scales such as, Clinical Dementia Rating (CDR), Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), etc. Multi-model neuroimaging evaluation screen the candidate neuroimaging markers, including structure and functional brain magnetic resonance imaging (MRI), Diffusion tensor image (DTI), 18 F-2-fluro-D-deoxy-glucose-positron emission tomography (18F-FDG-PET)，Amyloid-PET and tau-PET. To exploring neuroelectrophysiology biomarkers collect the data on polysomnography, resting state electroencephalogram, and evoked potentials (P1, N1, P2, N2, etc.). ELISA, SIMOA and other analytical methods were used to detect the contents related to dementia progression in the blood, cerebrospinal fluid, urine, saliva and feces. Multi-dimensional screening and identifying biomarkers of disease diagnosis and progression in all stages, from subjective cognitive impairment to mild cognitive impairment to dementia, in line with the characteristics of the Chinese population.
- Conditions
- Biomarkers, Dementia
- Keywords
- dementia, diagnostic biomarkers
- Medical subject headings
- Dementia
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 |
|---|---|---|
| dementia progression | dementia-P (Compared with the baseline, MMSE score declined ≥ 4 points per year) | |
| dementia stabilization | dementia-S (Compared with the baseline, MMSE score decreased < 4 points per year） |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of change in global cognition as measured by Clinical Dementia Rating (CDR).
Assess statistically significant difference in score between dementia-P and dementia-S using the neuropsychological scales CDR. CDR, a multidimensional scale for dementia severity, which scored 0-3, with higher scores indicating worse functioning.
Measured: 10 years
Secondary outcomes (7)
Rate of change in global cognition as measured by Mini-Mental State Examination (MMSE)
Assess statistically significant difference in score between dementia-P and dementia-S using the neuropsychological scales MMSE. MMSE scores range from 0-30, with higher scores representing better cognitive function.
Measured: 10 years
Rate of change in global cognition as measured by Montreal Cognitive Assessment (MoCA)
Assess statistically significant difference in score between dementia-P and dementia-S using the neuropsychological scales MoCA. MoCA scores range from 0-30, with higher scores representing better cognitive function.
Measured: 10 years
Rate of change in the severity of cognitive impairment as assessed by Alzheimer's Disease Assessment Scale-Cognitive section (ADAS-cog).
Assess statistically significant difference in score between dementia-P and dementia-S using the neuropsychological scales ADAS-cog. ADAS-cog scores range from 0-70, with higher scores indicating better global cognitive function.
Measured: 10 years
Rate of change in memory function as assessed by World Health Organization-University of California, Los Angeles, auditory verbal learning test (WHO-UCLA AVLT).
Assess statistically significant difference in score between dementia-P and dementia-S using the neuropsychological scales like WHO-UCLA AVLT. WHO-UCLA AVLT scores depend on the number of correct words, which ranges from 0-15, with higher scores representing better memory function.
Measured: 10 years
Rate of change in language function as assessed by Boston Naming Test (BNT).
Assess statistically significant difference in score between dementia-P and dementia-S using the neuropsychological scales like BNT. BNT scores range from 0-30, with higher scores representing better language function.
Measured: 10 years
Rate of change in psychobehavioral symptoms as assessed by Neuropsychiatric Inventory (NPI).
Assess statistically significant difference in score between dementia-P and dementia-S using the neuropsychological scales like NPI. Patient assessment grading scores range from 0-144 in NPI, and caregivers distress grading scores range from 0-60, with 0 representing the best.
Measured: 10 years
Rate of change in activities of daily living as assessed by Alzheimer's Disease Cooperative Study-Activity of Daily Living (ADCS-ADL).
Assess statistically significant difference between in score dementia-P and dementia-S using the neuropsychological scales like ADCS-ADL. ADCS-ADL scores range from 0-54, with higher scores indicating better completion ability.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2024
- Study start30 May 2024
- Primary completion10 May 2034 (estimated)
- Study completion10 May 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BiomarkersStudies of the same condition, open and under way.
- 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)
Sponsor and investigators
- Lead sponsor
- Cuibai Wei，Clinical Professor
- Sponsor type
- University, hospital or other
- Collaborators
- First Hospital of Shijiazhuang City, Chongqing Medical University, Tianjin Huanhu Hospital, Qianfoshan Hospital
- Responsible party
- Sponsor-investigator, Cuibai Wei，Clinical Professor, Xuanwu Hospital, Beijing
- Investigators
- Cuibai Wei, Principal investigator, Xuan Wu Hospital of Capital Medical University, Beijing, China, 100053
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06419101
- Sponsor's protocol ID
- KS2024051
- Status last verified
- Nov 2024
- First submitted
- 7 May 2024
- Last updated
- 14 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Study on Biomarkers of Cognitive Disorders in China
- ClinicalTrials.gov ID
- NCT06419101
- Acronym / sponsor ID
- KS2024051
- Conditions
- Biomarkers, Dementia
- Keywords
- dementia, diagnostic biomarkers
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Cuibai Wei，Clinical ProfessorUniversity, hospital or other
- Collaborators
- First Hospital of Shijiazhuang City, Chongqing Medical University, Tianjin Huanhu Hospital, Qianfoshan Hospital
- Study start
- 30 May 2024 (actual)
- Primary completion
- 10 May 2034 (estimated)
- Study completion
- 10 May 2035 (estimated)
- First posted
- 17 May 2024 (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.
Dementia is a syndrome characterized by progressive global cognitive impairment that impairs occupational, family, or social functioning. It detrimentally affects personal health and quality of life, imposing significant medical economy, social and psychological burden on the countries and the patients' family. The internationally renowned dementia cohort includes the DIAN that focused on genetics studies, the ADNI cohort featuring imaging and the FINGERS cohort focused on risk factor intervention, etc. Establishing standardized and shared longitudinal follow-up dementia cohorts and clinical database is an essential challenge for constructing dementia cohort in China. Moreover, there is a lack of large-scale prospective longitudinal follow-up cohorts within the Chinese population that cover subjective cognitive decline (SCD) to explore biomarkers with diagnostic and early warning value for different kinds of dementia and pre-dementia stages. The study will rely on the dementia cohort based on Chinese population to explore the biological phenotype characteristics of the pre-dementia stage and different dementia subtypes, and observe the dynamic change rules of the dementia cohort vertically, so as to foster early intervention and improve prognosis for individuals with dementia.
Detailed description
The 3000 patients with pre-dementia stage and different dementia subtypes will be enrolled in this study, and data will be collected in the baseline including demographics, clinical symptoms, assessment of neuropsychology, neuroimaging, neuroelectrophysiology, blood samples, cerebrospinal fluid, etc. The changes of these data were dynamically observed through an annual follow-up. According to the neuropsychological evaluation results of follow-up, the subjects were divided into dementia progression (dementia-P) and dementia stabilization (dementia-S). Difference in clinical phenotype, neuropsychology, electrophysiology, neuroimaging, and body fluid multi-omics indicators between the two subtypes were compared and analyzed. The neuropsychological testes in patients with dementia included some neuropsychological scales such as, Clinical Dementia Rating (CDR), Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), etc. Multi-model neuroimaging evaluation screen the candidate neuroimaging markers, including structure and functional brain magnetic resonance imaging (MRI), Diffusion tensor image (DTI), 18 F-2-fluro-D-deoxy-glucose-positron emission tomography (18F-FDG-PET)，Amyloid-PET and tau-PET. To exploring neuroelectrophysiology biomarkers collect the data on polysomnography, resting state electroencephalogram, and evoked potentials (P1, N1, P2, N2, etc.). ELISA, SIMOA and other analytical methods were used to detect the contents related to dementia progression in the blood, cerebrospinal fluid, urine, saliva and feces. Multi-dimensional screening and identifying biomarkers of disease diagnosis and progression in all stages, from subjective cognitive impairment to mild cognitive impairment to dementia, in line with the characteristics of the Chinese population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dementia progression | – | –dementia-P (Compared with the baseline, MMSE score declined ≥ 4 points per year) |
| dementia stabilization | – | –dementia-S (Compared with the baseline, MMSE score decreased < 4 points per year） |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This project will enroll about 3000 patients with dementia, who meet the inclusion and exclusion criteria, including subjective cognitive decline (SCD), MCI, AD, frontotemporal dementia (FTD), dementia with Lewy bodies (DLB), etc.
Key inclusion criteria (4 listed)
- Male or female patients aged ≥40 and ≤90years;
- Chief complaint or others describe a cognitive decline;
- Ability to communicate in Chinese;
- The patients and their families were informed and signed the informed consent.
Key exclusion criteria (8 listed)
- MMSE<10;
- There are other neurological diseases that can cause brain dysfunction (such as depression, brain tumors, Parkinson's disease, metabolic encephalopathy, encephalitis, multiple sclerosis, epilepsy, traumatic brain injury, normal intracranial pressure hydrocephalus, etc.);
- There are other systemic diseases that can cause cognitive impairment (such as hepatic insufficiency, renal insufficiency, Thyroid dysfunction, severe anemia, folic acid or vitamin B12 deficiency, syphilis, HIV infection, alcohol and drug abuse, etc.);
- Suffering from a disease that cannot cooperate with the completion of cognitive examination;
- There are contraindications to nuclear magnetic resonance;
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
Rate of change in global cognition as measured by Clinical Dementia Rating (CDR).
Time frame: 10 years
Assess statistically significant difference in score between dementia-P and dementia-S using the neuropsychological scales CDR. CDR, a multidimensional scale for dementia severity, which scored 0-3, with higher scores indicating worse functioning.
7 secondary outcomes
Rate of change in global cognition as measured by Mini-Mental State Examination (MMSE)
Time frame: 10 years
Rate of change in global cognition as measured by Montreal Cognitive Assessment (MoCA)
Time frame: 10 years
Rate of change in the severity of cognitive impairment as assessed by Alzheimer's Disease Assessment Scale-Cognitive section (ADAS-cog).
Time frame: 10 years
Rate of change in memory function as assessed by World Health Organization-University of California, Los Angeles, auditory verbal learning test (WHO-UCLA AVLT).
Time frame: 10 years
Rate of change in language function as assessed by Boston Naming Test (BNT).
Time frame: 10 years
Rate of change in psychobehavioral symptoms as assessed by Neuropsychiatric Inventory (NPI).
Time frame: 10 years
Rate of change in activities of daily living as assessed by Alzheimer's Disease Cooperative Study-Activity of Daily Living (ADCS-ADL).
Time frame: 10 years
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 14 Nov 2024.
Related trials for Biomarkers
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
Not yet recruitingObservational study
Periodontal Status and Biomarkers in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
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.
Cuibai Wei principal investigator
Xuan Wu Hospital of Capital Medical University, Beijing, China, 100053
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 Biomarkers and Dementia, run by Cuibai Wei，Clinical Professor 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 4 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 14 Nov 2024. 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 Cuibai Wei (83198319, weicb@xwhosp.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of change in global cognition as measured by Clinical Dementia Rating (CDR). (time frame: 10 years). 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 14 Nov 2024.