Study on Biomarkers for Early Diagnosis of Alzheimer's Disease

• Set up a large population- based cohort including AD, MCI, pre-MCI, other neurodegenerative diseases, and elderly individuals with normal cognitive function.
• 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.
• Screen biomarkers with high specificity and sensitivity from peripheral blood, cerebrospinal fluid and neuroimaging to distinguish different clinical stages of AD at baseline.
• Screen the AD-associated gene and their risk variants.
• Establish a panel of AD-specific biomarkers for the preliminary development of diagnostic kit.
• Identify AD-relevant factors and the special biomarkers to create a preliminary risk models to predict the onset and progression of AD.
• 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.

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.