Cognitive DysfunctionHAPCADNCT06679296
Study on Aging and Cognitive Impairment in China
An observational study of Cognitive Dysfunction and Aging, run by First Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial summary
Background: By the end of 2022, China had about 280 million people aged 60 and older, making up 19.8% of the population. This number is projected to exceed 300 million by the end of the 14th Five-Year Plan and 400 million by 2035, which would be over 30%. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cognitive Dysfunction, Aging
- How many people
- 20,000 participants
- Where
- 1 siteChina
- Study dates
- 20 Nov 2024to 31 Dec 2033
- 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: The study population is sourced from communities, hospitals, and healthy volunteers. There is no requirement for randomization of study subjects at enrollment. However, during further testing and analysis, one or more researchers select appropriate case samples for grouping and blinding assessors, and analysts is implemented to prevent bias.
Who may be able to join
- Ability to sign an informed consent form: Participants and/or their legally authorized representatives, in case of diminished decision-making capacity, are capable of reading, understanding, and providing written informed consent as per national legal requirements.
- Capability to complete assessments independently or with assistance.
- Willingness and ability to fulfill all study requirements, including peripheral organ function assessments, EEG, lumbar puncture, MRI, and PET imaging examinations.
- Agreement to participate in follow-up visits.
Who cannot join
- Terminal stage of significant diseases such as malignant tumors or autoimmune diseases at enrollment;
- Substance abusers.
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
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 32500
Sipei Pan Dr., +8613758710622, pansipei@wmu.edu.cn
About this study
Official title: A Longitudinal Study on the Aging of Health and Cognitive Impairment in China
Background: By the end of 2022, China had about 280 million people aged 60 and older, making up 19.8% of the population. This number is projected to exceed 300 million by the end of the 14th Five-Year Plan and 400 million by 2035, which would be over 30%. The 20th National Congress emphasized the need for a proactive strategy to tackle aging challenges. Approximately 6.04% of the elderly have dementia, with 3.94% having Alzheimer's disease. This totals around 15 million people with dementia. To address this, the China Cohort Consortium on Aging and Cognitive Impairment Development has been proposed to study health and cognitive changes in different age groups, aiming to support healthy aging policies. Methods: Participants from various age groups (children, youth, middle-aged, elderly) will be recruited from hospitals, schools, and communities using stratified sampling. They will undergo detailed medical examinations focusing on aging, cognitive impairments, and related diseases. A new database will track healthy aging and cognitive impairment development. Content: The study will involve comprehensive medical examinations, including physiological assessments, psychological evaluations, cognitive screenings, daily life assessments, imaging studies, and blood tests, to establish a detailed health and cognitive impairment database. The research will also investigate integrated intervention models in hospital, community, and home settings, develop remote medical management systems, and devise biomarker test kits for aging and cognitive impairments. Furthermore, it will concentrate on non-pharmacological interventions and artificial intelligence systems for the early detection, prevention, and treatment of aging-related conditions. Objectives: The China Cohort Consortium on Aging and Cognitive Impairment Development, commencing with the HAPCAD study, aims to monitor changes across various age groups, evaluate the impact of aging on health and cognitive function, and design targeted interventions. The objective is to enhance health management and services related to aging, establish effective strategies, develop therapeutic drugs, and promote healthy aging.
Read the detailed description
Research Objectives:
Establish detailed medical examinations for population cohorts across different age groups, including physiological checks, psychological assessments, cognitive function screenings, evaluations of daily life abilities, imaging, and blood tests, to build a comprehensive health and mental impairments database. Develop artificial intelligence systems for early warnings related to aging-related diseases and create prevention and treatment strategies. Focus on advancing health management, interventions, research, and services related to healthy aging and aging-related diseases, and develop effective intervention strategies and therapeutic drugs to promote healthy aging.
Research Content:
- Screening and Tracking: Implement a long-term cohort study on healthy aging and cognitive impairment to understand changes in physiological, psychological, mental, and daily life abilities across different age groups. Analyze the effects of genetic, environmental, and lifestyle factors on healthy aging and cognitive impairments. Based on identified risk factors, develop personalized lifestyle interventions and management plans. The study will include 20,000 participants.
- Omics Approaches: Use genomics, transcriptomics, proteomics, and metabolomics to identify biomarkers associated with healthy aging, cognitive impairments, and other aging-related diseases. This will support further primary research in these areas.
Research Methods and Technical Roadmap:
- Questionnaire Survey: Collect demographic information (age, gender, height, weight, education, occupation, smoking, alcohol consumption, dietary habits, medical history, family history, medication history, etc.) and conduct various scale assessments. Specific scales will include Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA) Background Version, memory and digit span tests, Hamilton Depression Rating Scale (HAMD), Hamilton Anxiety Rating Scale (HAMA), PHQ-9 Depression Screening Scale, HIS Ischemia Scale, Neuropsychiatric Inventory (NPI), Pittsburgh Sleep Quality Index (PSQI), International Physical Activity Questionnaire (IPAQ), Activities of Daily Living (ADL), Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-PLUS), Clinical Dementia Rating (CDR) scale, and Epidemic Protective Behavior Scale.
- Clinical Laboratory Index Collection: Perform blood tests (complete blood count, biochemical tests, glucose, glycated hemoglobin, lipid profile, folic acid, vitamin B, homocysteine, thyroid function, C-reactive protein), urinalysis, stool tests, and measure biomarkers (ApoE, T-tau, NFL, GFAP, UCHL1, pTau-181, pTau-217, Aβ40, Aβ42, etc.).
- Clinical Examination Index Collection: Conduct brain MRI, Transcranial Doppler (TCD), carotid artery and vertebral artery ultrasound, echocardiogram, lower limb vascular ultrasound, ambulatory blood pressure monitoring, fundus photography, CT scans, and review pathological reports.
- Sample Collection: Collect blood, cerebrospinal fluid, brain tissue, stool, urine, and saliva as needed for clinical diagnostics. Additional samples (20 ml blood, 10 ml urine, 30 ml stool, 20 ml saliva) will be collected, processed, and analyzed for genomics, transcriptomics, proteomics, and metabolomics to identify specific biomarkers.
4.1. Genomics: Use the Illumina platform for whole-genome sequencing (WGS) to identify genetic variations and conduct genotype diversity, evolution analysis, and disease screening. Perform whole-genome bisulfite sequencing (WGBS) to study DNA methylation, which supports research on genome-wide methylation modifications relevant to aging and diseases.
4.2. Transcriptomics: Utilize the Illumina platform for next-generation sequencing to analyze coding and non-coding RNAs. Employ the 10x Chromium Single Cell Gene Expression Solution platform for single-cell gene expression profiling, enabling detailed analysis of cell populations and creating single-cell expression atlases.
4.3. Proteomics and Metabolomics: Study protein composition and activity patterns using proteomics and explore small molecule metabolites using metabolomics. Integrate data from both approaches to identify differential proteins and metabolites and describe molecular regulatory mechanisms.
Follow-Up and Tracking:
Track and follow up with enrolled participants.
Experimental Methods:
Employ traditional and advanced statistical methods, including t-tests, non-parametric tests, chi-square tests, logistic regression, Cox proportional hazards models, artificial neural networks, and Bayesian models. Analyze data to identify biomarkers for disease prediction, explore disease mechanisms, and guide treatment strategies. Utilize samples for scientific analysis, molecular experiments, and drug development.
Key Technologies and Descriptions:
Sample Processing: Use centrifuges, slicers, pipettes, and DNA/RNA extraction instruments. Following standardized procedures, store samples in low-temperature equipment, including refrigerators, freezers, and liquid nitrogen tanks.
Simoa Detection Technology:
Utilize Simoa for single-molecule detection with high sensitivity, using capture antibody binding sites on magnetic beads and detecting signals using CCD cameras. This technology allows for precise measurement of protein concentrations.
Annual Research Plan:
Recruit volunteers from hospitals of all age groups for comprehensive physical examinations, aiming to establish a detailed human growth and aging map.
- Conditions
- Cognitive Dysfunction, Aging
- Keywords
- Cognitive dysfunction, aging, Alzheimer disease
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease
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 |
|---|---|---|
| Observation group | Establish a screening and long-term tracking cohort study related to healthy aging and the development of cognitive impairments to understand changes in physiological, psychological, mental, and daily living abilities across different age groups in humans. Analyze genetic factors, environmental influences, lifestyle, and their impacts on the occurrence and development of healthy aging, cognitive impairments, and other age-related diseases. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing the prevalence of cognitive impairment in China based on MMSE, MoCA and CDR.
The statement involves evaluating the prevalence of cognitive impairment in China using three assessment tools: the Mini-Mental State Examination (MMSE), the Montreal Cognitive Assessment (MoCA), and the Clinical Dementia Rating (CDR). MMSE: This test has a maximum score of 30 points, with scores below 24 typically indicating cognitive impairment. MoCA: The MoCA also has a maximum score of 30 points, where a score of 26 or lower indicates cognitive impairment. CDR: The CDR uses a scale from 0 to 3, where 0 indicates no cognitive impairment, 0.5 suggests mild cognitive impairment, 1 denotes mild dementia, 2 indicates moderate dementia, and 3 reflects severe dementia.
Measured: through study completion, an average of 5 year.
Change in Alzheimer disease biomarkers over time
Aβ, t-tau and p-tau levels in pg/ml
Measured: through study completion, an average of 3 year.
Secondary outcomes (4)
Changes of brain structure at different stage of cognitive impairment in Alzheimer disease in China.
Changes of structure of the whole brain, hippocampus other brain structures measured by MRI.
Measured: through study completion, an average of 5 year.
Changes of brain glucose metabolism at different stage of cognitive impairment in Alzheimer disease in China.
Changes of glucose metabolism of the whole brain, hippocampus and other brain structures as measured by 18F-fluorodeoxyglucose (FDG)-positron emission tomography (PET).
Measured: through study completion, an average of 3 year.
Changes of brain amyloid deposition at different stage of cognitive impairment in Alzheimer disease in China.
Changes of amyloid deposition of the whole brain, hippocampus and other brain structures as measured by amyloid PET.
Measured: through study completion, an average of 3 year.
Changes of brain tau deposition at different stage of cognitive impairment in Alzheimer disease in China.
Changes of tau deposition of the whole brain, hippocampus and other brain structures as measured by tau PET.
Measured: through study completion, an average of 3 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start20 Nov 2024 (estimated)
- Primary completion31 Dec 2033 (estimated)
- Study completion31 Dec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DysfunctionStudies 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
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Wenzhou Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Wenzhou Medical University
- Responsible party
- Sponsor
- Investigators
- Weihong Song Prof., Study chair, First Affiliated Hospital of Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06679296
- Sponsor's protocol ID
- weihongsong2024
- Acronym
- HAPCAD
- Status last verified
- Oct 2024
- First submitted
- 11 Sep 2024
- Last updated
- 7 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Longitudinal Study on the Aging of Health and Cognitive Impairment in China
- ClinicalTrials.gov ID
- NCT06679296
- Acronym / sponsor ID
- HAPCAD / weihongsong2024
- Conditions
- Cognitive Dysfunction, Aging
- Keywords
- Cognitive dysfunction, aging, Alzheimer disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Collaborators
- Wenzhou Medical University
- Study start
- 20 Nov 2024 (estimated)
- Primary completion
- 31 Dec 2033 (estimated)
- Study completion
- 31 Dec 2033 (estimated)
- First posted
- 7 Nov 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.
Background: By the end of 2022, China had about 280 million people aged 60 and older, making up 19.8% of the population. This number is projected to exceed 300 million by the end of the 14th Five-Year Plan and 400 million by 2035, which would be over 30%. The 20th National Congress emphasized the need for a proactive strategy to tackle aging challenges. Approximately 6.04% of the elderly have dementia, with 3.94% having Alzheimer's disease. This totals around 15 million people with dementia. To address this, the China Cohort Consortium on Aging and Cognitive Impairment Development has been proposed to study health and cognitive changes in different age groups, aiming to support healthy aging policies. Methods: Participants from various age groups (children, youth, middle-aged, elderly) will be recruited from hospitals, schools, and communities using stratified sampling. They will undergo detailed medical examinations focusing on aging, cognitive impairments, and related diseases. A new database will track healthy aging and cognitive impairment development. Content: The study will involve comprehensive medical examinations, including physiological assessments, psychological evaluations, cognitive screenings, daily life assessments, imaging studies, and blood tests, to establish a detailed health and cognitive impairment database. The research will also investigate integrated intervention models in hospital, community, and home settings, develop remote medical management systems, and devise biomarker test kits for aging and cognitive impairments. Furthermore, it will concentrate on non-pharmacological interventions and artificial intelligence systems for the early detection, prevention, and treatment of aging-related conditions. Objectives: The China Cohort Consortium on Aging and Cognitive Impairment Development, commencing with the HAPCAD study, aims to monitor changes across various age groups, evaluate the impact of aging on health and cognitive function, and design targeted interventions. The objective is to enhance health management and services related to aging, establish effective strategies, develop therapeutic drugs, and promote healthy aging.
Detailed description
Research Objectives:
Establish detailed medical examinations for population cohorts across different age groups, including physiological checks, psychological assessments, cognitive function screenings, evaluations of daily life abilities, imaging, and blood tests, to build a comprehensive health and mental impairments database. Develop artificial intelligence systems for early warnings related to aging-related diseases and create prevention and treatment strategies. Focus on advancing health management, interventions, research, and services related to healthy aging and aging-related diseases, and develop effective intervention strategies and therapeutic drugs to promote healthy aging.
Research Content:
- Screening and Tracking: Implement a long-term cohort study on healthy aging and cognitive impairment to understand changes in physiological, psychological, mental, and daily life abilities across different age groups. Analyze the effects of genetic, environmental, and lifestyle factors on healthy aging and cognitive impairments. Based on identified risk factors, develop personalized lifestyle interventions and management plans. The study will include 20,000 participants.
- Omics Approaches: Use genomics, transcriptomics, proteomics, and metabolomics to identify biomarkers associated with healthy aging, cognitive impairments, and other aging-related diseases. This will support further primary research in these areas.
Research Methods and Technical Roadmap:
- Questionnaire Survey: Collect demographic information (age, gender, height, weight, education, occupation, smoking, alcohol consumption, dietary habits, medical history, family history, medication history, etc.) and conduct various scale assessments. Specific scales will include Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA) Background Version, memory and digit span tests, Hamilton Depression Rating Scale (HAMD), Hamilton Anxiety Rating Scale (HAMA), PHQ-9 Depression Screening Scale, HIS Ischemia Scale, Neuropsychiatric Inventory (NPI), Pittsburgh Sleep Quality Index (PSQI), International Physical Activity Questionnaire (IPAQ), Activities of Daily Living (ADL), Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-PLUS), Clinical Dementia Rating (CDR) scale, and Epidemic Protective Behavior Scale.
- Clinical Laboratory Index Collection: Perform blood tests (complete blood count, biochemical tests, glucose, glycated hemoglobin, lipid profile, folic acid, vitamin B, homocysteine, thyroid function, C-reactive protein), urinalysis, stool tests, and measure biomarkers (ApoE, T-tau, NFL, GFAP, UCHL1, pTau-181, pTau-217, Aβ40, Aβ42, etc.).
- Clinical Examination Index Collection: Conduct brain MRI, Transcranial Doppler (TCD), carotid artery and vertebral artery ultrasound, echocardiogram, lower limb vascular ultrasound, ambulatory blood pressure monitoring, fundus photography, CT scans, and review pathological reports.
- Sample Collection: Collect blood, cerebrospinal fluid, brain tissue, stool, urine, and saliva as needed for clinical diagnostics. Additional samples (20 ml blood, 10 ml urine, 30 ml stool, 20 ml saliva) will be collected, processed, and analyzed for genomics, transcriptomics, proteomics, and metabolomics to identify specific biomarkers.
4.1. Genomics: Use the Illumina platform for whole-genome sequencing (WGS) to identify genetic variations and conduct genotype diversity, evolution analysis, and disease screening. Perform whole-genome bisulfite sequencing (WGBS) to study DNA methylation, which supports research on genome-wide methylation modifications relevant to aging and diseases.
4.2. Transcriptomics: Utilize the Illumina platform for next-generation sequencing to analyze coding and non-coding RNAs. Employ the 10x Chromium Single Cell Gene Expression Solution platform for single-cell gene expression profiling, enabling detailed analysis of cell populations and creating single-cell expression atlases.
4.3. Proteomics and Metabolomics: Study protein composition and activity patterns using proteomics and explore small molecule metabolites using metabolomics. Integrate data from both approaches to identify differential proteins and metabolites and describe molecular regulatory mechanisms.
Follow-Up and Tracking:
Track and follow up with enrolled participants.
Experimental Methods:
Employ traditional and advanced statistical methods, including t-tests, non-parametric tests, chi-square tests, logistic regression, Cox proportional hazards models, artificial neural networks, and Bayesian models. Analyze data to identify biomarkers for disease prediction, explore disease mechanisms, and guide treatment strategies. Utilize samples for scientific analysis, molecular experiments, and drug development.
Key Technologies and Descriptions:
Sample Processing: Use centrifuges, slicers, pipettes, and DNA/RNA extraction instruments. Following standardized procedures, store samples in low-temperature equipment, including refrigerators, freezers, and liquid nitrogen tanks.
Simoa Detection Technology:
Utilize Simoa for single-molecule detection with high sensitivity, using capture antibody binding sites on magnetic beads and detecting signals using CCD cameras. This technology allows for precise measurement of protein concentrations.
Annual Research Plan:
Recruit volunteers from hospitals of all age groups for comprehensive physical examinations, aiming to establish a detailed human growth and aging map.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observation group | – | –Establish a screening and long-term tracking cohort study related to healthy aging and the development of cognitive impairments to understand changes in physiological, psychological, mental, and daily living abilities across different age groups in humans. Analyze genetic factors, environmental influences, lifestyle, and their impacts on the occurrence and development of healthy aging, cognitive impairments, and other age-related diseases. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population is sourced from communities, hospitals, and healthy volunteers. There is no requirement for randomization of study subjects at enrollment. However, during further testing and analysis, one or more researchers select appropriate case samples for grouping and blinding assessors, and analysts is implemented to prevent bias.
Key inclusion criteria (4 listed)
- Ability to sign an informed consent form: Participants and/or their legally authorized representatives, in case of diminished decision-making capacity, are capable of reading, understanding, and providing written informed consent as per national legal requirements.
- Capability to complete assessments independently or with assistance.
- Willingness and ability to fulfill all study requirements, including peripheral organ function assessments, EEG, lumbar puncture, MRI, and PET imaging examinations.
- Agreement to participate in follow-up visits.
Key exclusion criteria (2 listed)
- Terminal stage of significant diseases such as malignant tumors or autoimmune diseases at enrollment;
- Substance abusers.
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
Assessing the prevalence of cognitive impairment in China based on MMSE, MoCA and CDR.
Time frame: through study completion, an average of 5 year.
The statement involves evaluating the prevalence of cognitive impairment in China using three assessment tools: the Mini-Mental State Examination (MMSE), the Montreal Cognitive Assessment (MoCA), and the Clinical Dementia Rating (CDR). MMSE: This test has a maximum score of 30 points, with scores below 24 typically indicating cognitive impairment. MoCA: The MoCA also has a maximum score of 30 points, where a score of 26 or lower indicates cognitive impairment. CDR: The CDR uses a scale from 0 to 3, where 0 indicates no cognitive impairment, 0.5 suggests mild cognitive impairment, 1 denotes mild dementia, 2 indicates moderate dementia, and 3 reflects severe dementia.
Change in Alzheimer disease biomarkers over time
Time frame: through study completion, an average of 3 year.
Aβ, t-tau and p-tau levels in pg/ml
4 secondary outcomes
Changes of brain structure at different stage of cognitive impairment in Alzheimer disease in China.
Time frame: through study completion, an average of 5 year.
Changes of brain glucose metabolism at different stage of cognitive impairment in Alzheimer disease in China.
Time frame: through study completion, an average of 3 year.
Changes of brain amyloid deposition at different stage of cognitive impairment in Alzheimer disease in China.
Time frame: through study completion, an average of 3 year.
Changes of brain tau deposition at different stage of cognitive impairment in Alzheimer disease in China.
Time frame: through study completion, an average of 3 year.
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 7 Nov 2024.
- Individual participant dataSharing planned: No
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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.
Weihong Song Prof. study chair
First Affiliated Hospital of Wenzhou Medical University
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 Cognitive Dysfunction and Aging, run by First Affiliated Hospital of Wenzhou Medical University 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 2 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 7 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 Sipei Pan Dr. (86+13758710622, pansipei@wmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessing the prevalence of cognitive impairment in China based on MMSE, MoCA and CDR. (time frame: through study completion, an average of 5 year.). The study lists 2 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 7 Nov 2024.