- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03672448
The China Longitudinal Aging Study of Cognitive Impairment
January 8, 2020 updated by: Shanghai Mental Health Center
Shanghai Mental Health Center, Shanghai Jiaotong University School of Medicine
Alzheimer's disease (AD) and Vascular dementia (VaD) have become common diseases in the elderly.
The burden of dementia is rising in China, with major medical, social and economic impacts.
To address this important public health problem, cohort study on elderly cognitive disorders should be carry out.
The methods of early prevention, early diagnosis and early treatment the cognitive disorders in elderly should be found to reduce the burden of the social and economic issue due to dementia.
At present, the international corresponding guidelines have taken gene and brain imaging biomarkers as important indicators of dementia pathogenesis research, accurate diagnosis and targeted intervention.
Based on the above understanding, the study carry out the population cohort study based on accurate diagnosis and construct the high standard information and sample bank.
The study will establish the standard and quality system of geriatric cognitive disorders cohort study (unified standards and norms).
The study will integrate the standard biological samples stratified acquisition function module (homogeneity and precision) of elderly cognitive disorders, and complete the construction of biological samples bank and clinical diagnosis and treatment information database.
The study will apply and develop brain structural and pathological imaging technology to support precision diagnosis of senile cognitive disorders.
The study will evaluate whether peripheral nerve degeneration can predict central nervous system degeneration based on the large cohort of elderly study.
In addition, The study will make an effective supplement the sample bank construction of Shanghai Mental Health Center.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
The neuropsychological test battery are used to access the cognitive function of subjects in the study.
The brain MRI and biochemical examination will be done in the screening period.
The samples such as plasma, serum, urine and faeces et al. of the subjects will be collected in the study.
Study Type
Observational
Enrollment (Anticipated)
10000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Shifu Xiao, M.D., Ph.D.
- Phone Number: 73441 00862164387250
- Email: xiaoshifu@msn.com
Study Contact Backup
- Name: Tao Wang, M.D., Ph.D.
- Phone Number: 73220 00862164387250
- Email: wtshhwy@163.com
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200030
- Recruiting
- SHANGHAI MENTAL HEALTH CENTRE
-
Contact:
- Shifu Xiao, M.D., Ph.D.
-
Sub-Investigator:
- Tao Wang, M.D., Ph.D.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
10,000 adult Chinese aged 60 and up who have been living Shanghai will be recruited.
Description
Inclusion Criteria:
- registered residents in the community;
- ≥ 60 years;
- without schizophrenia or mental retardation;
- be able to communicate and accept physical and cognitive examinations
Exclusion Criteria:
- blind
- deaf mute
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Neurocognitive disorder
Dementias
|
Naturalistic observation
Other Names:
|
Normal Aging
Normal Aging with normal cognitive function
|
Naturalistic observation
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevalence, incidence of neurocognitive disorder
Time Frame: 5 years
|
Prevalence, incidence of neurocognitive disorder such as AD, MCI and other types of dementia
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevalence, incidence of mood disorder
Time Frame: 5 years
|
Prevalence, incidence of mood disorder such as depression, anxiaty
|
5 years
|
conversion rate
Time Frame: 5 years
|
conversion rate of neurocognitive disorder from Normal Elderly
|
5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Huafang Li, M.D., Ph.D., SHANGHAI MENTAL HEALTH CENTRE
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
September 1, 2018
Primary Completion (ANTICIPATED)
November 30, 2023
Study Completion (ANTICIPATED)
November 30, 2023
Study Registration Dates
First Submitted
January 26, 2018
First Submitted That Met QC Criteria
September 13, 2018
First Posted (ACTUAL)
September 14, 2018
Study Record Updates
Last Update Posted (ACTUAL)
January 10, 2020
Last Update Submitted That Met QC Criteria
January 8, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Neurocognitive Disorders
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Movement Disorders
- Synucleinopathies
- Neurodegenerative Diseases
- Tauopathies
- Cognition Disorders
- Intracranial Arterial Diseases
- Intracranial Arteriosclerosis
- Leukoencephalopathies
- Depression
- Dementia
- Alzheimer Disease
- Cognitive Dysfunction
- Lewy Body Disease
- Dementia, Vascular
Other Study ID Numbers
- CRC2017ZD02
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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