China Alzheimer's and Neurodegenerative Disorder Research

Recruiting

• Conditions: Cognitive Impairment

• Registration Number: NCT04320368
• Lead Sponsor: Beijing Tiantan Hospital

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.

Study Timeline

• Study Start: 2019-07-08
• Study First Submitted: 2020-03-10
• Study First Submitted QC: 2020-03-22
• Study First Posted: 2020-03-25
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-06
• Last Update Posted: 2023-08-08
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Data records	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	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)

Trial Locations

Locations (1)

Beijing Tiantan Hospital，Capital Medical University; 🇨🇳 Beijing, Beijing, China