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Clinical Trials/NCT04320368
NCT04320368
Recruiting
Not Applicable

China National Clinical Research Center Alzheimer's Disease and Neurodegenerative Disorder Research

Beijing Tiantan Hospital1 site in 1 country3,100 target enrollmentJuly 8, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cognitive Impairment
Sponsor
Beijing Tiantan Hospital
Enrollment
3100
Locations
1
Primary Endpoint
Data records
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

This is a multi-center study that has three cohorts: 1) cognitive normal cohort (CN), 2) Alzheimer's disease cohort (AD) and 3) vascular cognitive impairment cohort (VCI). The goal of this study is to understand the risk factors of AD and VCI and to identify high risk patients for early intervention. It will collect demographic information, family history, medical history, neuropsychological tests, imaging studies and biological samples through standard and uniform procedures.

Detailed Description

In this prospective study, we will recruit subjects into one of the three groups based on inclusion and exclusion criteria: 1) CN, 2) AD and 3) VCI. We will follow up with each of them subject at designated time points up to 2 years. We will collect demographic, medical, imaging (MRI and PET scans), genetic information and various biological samples (blood, saliva, urine and feces) during the study period. This study uses a case-control study design. The matched cases will have similar age, gender and education levels. By studying the relationship between risk factors of AD and VCI, we will establish norms and parameters in the Chinese population.

Registry
clinicaltrials.gov
Start Date
July 8, 2019
End Date
December 31, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Beijing Tiantan Hospital
Responsible Party
Principal Investigator
Principal Investigator

Shiping Li

Principle Investigator

Beijing Tiantan Hospital

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Data records

Time Frame: 4-5 years

We will record the number of participants at several follow-up visits, the basic condition at the follow-up. If the visit is not completed, record the cause of this loss. At baseline, record the demographic information, past medical history and medication history, vital signs and neuropsychological scales. The PET-CT scan were recorded during the 4-year visit. Collect the results of cerebral MRI, laboratory tests and neuropsychological scales of all participants at baseline, 12, 24, 36 and 48 months and biological samples. For VCI cohort, we will record the basic conditions and partial neuropsychological scales at 3-month and 6-month follow-up.

Neuropsychological scales

Time Frame: 4-5 years

Mini-Mental State Examination (MMSE), Montreal-Cognitive Assessment (MoCA), the Geriatric Depression Scale (GDS), The Activities of Daily Living Questionnaire(ADL), Digit Span Memory Test, Rey Auditory Verbal Learning Test (RAVLT), Rey-Osterrieth Complex Figure Test(ROCF), Trail Making Test A and B, Stroop test, Verbal Fluency Test, Boston Naming Test, Clock-Drawing Test, Narcissism Test (NPI), Symbol Digit Modalities Test(SDMT), Clinical Dementia Rating (CDR)

Study Sites (1)

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