NCT04575337 Study on Biomarkers for Early Diagnosis of Alzheimer's Disease
| NCT ID | NCT04575337 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Capital Medical University |
| Condition | Alzheimer Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 6,000 participants |
| Start Date | 2020-05-28 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 6,000 participants in total. It began in 2020-05-28 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The project of Bio-AD is a population- based cohort study among the elderly in China. The project includes not only Alzheimer's disease (AD including familial AD and sporadic AD), but also other clinical stage of AD, as well as elderly people with normal cognitive function. The project will collect, detect and screen the special biomarkers at different clinical stage of AD based on body fluid, gene and brain image. The standard and consistent assessment protocols are employed to obtain clinical, cognitive, genetic, neuroimaging and biospecimen data. The purpose of this project is to establish a panel of biomarkers which could be used to diagnose AD at the early stage, and to establish a risk prediction models for AD to predict the 5-years risk of the onset and progression of AD among elderly population in China.
Eligibility Criteria
Inclusion Criteria: * Written informed consent obtained from participant or legal guardian prior to any study-related procedures. * Aged 18 (inclusive) or older. * Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-R). The diagnosis of AD is made using the National Institute of Neurologic and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS- ADRDA) or National Institute on Aging and the Alzheimer's Assocation (NIA-AA) criteria. A diagnosis of mild cognitive impairment (MCI) is assigned according to Petersen criteria. A diagnosis of pre-MCI group is assigned by β-Amyloid positive or APOE ε4 carrier or complains of cognitive impairment, but not up to MCI or cognitive impairment. Normal cognitive function assessed/evaluated by MMSE, CDR and other cognitive function scales. * Follow up 5 years and collect the information. Exclusion Criteria: * Under age 18. * Medical or psychiatric illness that would interfere in completing initial and follow-up visits. * No one can serve as a study informant. * With current or past neurological or psychiatric illnesses such as schizophrenia, epilepsy, brain tumors, severe head trauma and other diseases which can induce dementia. * Refused to complete a cognitive test and provide biospecimen. * With history of alcohol or drug abuse.
Contact & Investigator
Jianping Jia, Doctor
STUDY CHAIR
Xuanwu Hospital of Capital Medical University
Frequently Asked Questions
Who can join the NCT04575337 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Alzheimer Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04575337 currently recruiting?
Yes, NCT04575337 is actively recruiting participants. Contact the research team at jiajp@vip.126.com for enrollment information.
Where is the NCT04575337 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT04575337 clinical trial?
NCT04575337 is sponsored by Capital Medical University. The principal investigator is Jianping Jia, Doctor at Xuanwu Hospital of Capital Medical University. The trial plans to enroll 6,000 participants.
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