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Study on Biomarkers for Early Diagnosis of Alzheimer's Disease

NCT04575337 · Capital Medical University
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Official title
Study on Body Fluid, Gene and Neuroimaging Biomarkers for Early Diagnosis of Alzheimer's Disease
About this study
1. Set up a large population- based cohort including AD, MCI, pre-MCI, other neurodegenerative diseases, and elderly individuals with normal cognitive function. 2. Collect the information of clinical and neuropsychological assessment, individual traits and social environmental factors, and neuroimaging data, as well as the biological samples, such as peripheral blood and cerebrospinal fluid. 3. Screen biomarkers with high specificity and sensitivity from peripheral blood, cerebrospinal fluid and neuroimaging to distinguish different clinical stages of AD at baseline. 4. Screen the AD-associated gene and their risk variants. 5. Establish a panel of AD-specific biomarkers for the preliminary development of diagnostic kit. 6. Identify AD-relevant factors and the special biomarkers to create a preliminary risk models to predict the onset and progression of AD. 7. Follow up the cohort for next 5 years and collect the multiple information and biological samples each year to validate and revise the risk prediction models and the diagnostic kit of AD.
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.
Study design
Enrollment target: 6000 participants
Age groups: adult, older_adult
Timeline
Starts: 2020-05-28
Estimated completion: 2027-06-30
Last updated: 2026-03-23
Primary outcomes
  • A multiple diagnostic kit for early diagnosis of AD. (An Average of 1 year)
  • A 5-years risk prediction model for onset and progression of AD among elderly population in China. (An Average of 1 year)
Sponsor
Capital Medical University · other
Contacts & investigators
ContactJianping Jia, Doctor · contact · jiajp@vip.126.com · #8610-83199449
InvestigatorJianping Jia, Doctor · study_chair, Xuanwu Hospital of Capital Medical University
All locations (1)
Xuanwu Hospital of Capital Medical UniversityRecruiting
Beijing, Beijing Municipality, China
Study on Biomarkers for Early Diagnosis of Alzheimer's Disease · TrialPath