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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03672448
Other study ID # CRC2017ZD02
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 1, 2018
Est. completion date November 30, 2023

Study information

Verified date January 2020
Source Shanghai Mental Health Center
Contact Shifu Xiao, M.D., Ph.D.
Phone 00862164387250
Email xiaoshifu@msn.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 10000
Est. completion date November 30, 2023
Est. primary completion date November 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years and older
Eligibility 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 Design


Intervention

Other:
Naturalistic observation
Naturalistic observation

Locations

Country Name City State
China Shanghai Mental Health Centre Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Mental Health Center

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Prevalence, incidence of neurocognitive disorder Prevalence, incidence of neurocognitive disorder such as AD, MCI and other types of dementia 5 years
Secondary Prevalence, incidence of mood disorder Prevalence, incidence of mood disorder such as depression, anxiaty 5 years
Secondary conversion rate conversion rate of neurocognitive disorder from Normal Elderly 5 years
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