Alzheimers disease
Conditions
Interventions
Gold Standard:Clinical Diagnostic Standard: Core clinical diagnostic criteria for Alzheimers disease (AD) established by the National Institute on Aging–Alzheimer's Association (NIA-AA)
PET Diagnosti
Index test:chemiluminescence immunoassay (CLIA) to measure peripheral blood biomarkers, including Aß1-40?Aß1-42?p-Tau-181?p-Tau-217?NFL?GFAP etc.
Sponsors
Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Age
50 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Enrollment criteria for MCI-AD/mild AD (1) Age 50-80 years old (inclusive), gender is not limited; (2) The subject has a primary school education level or above, and has the ability to complete the cognitive ability measurement and other tests specified in the program; (3) memory loss for at least 12 months with a progressive tendency to worsen; (4) Meet the core clinical diagnostic criteria for MCI or AD as defined by the National Institute on Aging (NIA)-Alzheimer's Association (AA) (NIA-AA); (5) CDR assessment 0.5-1 points; (6) Hamilton Depression Rating Scale/17-item version (HAMD) total score 1.5cm, and no cavity infarct foci of key sites such as thalamus, hippocampus, entorhinal cortex, paranasal cortex, cortex and subcortical gray matter nucleus; (8) There were no obvious signs on neurological examination; (9) Before performing protocol-related operations or examinations, subjects must sign a written informed consent form. If the legal guardian is unable to sign on behalf of the subject due to cognitive limitations, a legal guardian is required to sign on the subject's behalf; At the same time, the legal guardian needs to sign the informed consent form. 2.AD enrollment criteria for high-risk populations (1) Age 50-80 years old (inclusive), gender is not limited; (2) The subject has a primary school education level or above, and has the ability to complete the cognitive ability measurement and other tests specified in the program; (3) no memory loss; (4) MemTrax any indicator 10% of the lower limit of the norm; (5) CDR assessment is 0 points; (6) The total score of MMSE is 27-30 points; (7) Hamilton Depression Rating Scale/17-item version (HAMD) total score <=10 points; (8) There were no obvious signs on neurological examination; (9) Before performing protocol-related operations or examinations, subjects must sign a written informed consent form.
Exclusion criteria
Exclusion criteria: Exclusion Criteria: (1) Other causes of cognitive impairment: including but not limited to other neurodegenerative diseases (frontotemporal dementia, Parkinson's disease dementia, Lewy body dementia, PSP, CBD, etc.), vascular cognitive impairment, central nervous system infection (such as syphilis, or known AIDS patients, etc.), Creutzfeldt-Jakob disease, Huntington's disease, traumatic brain dementia, other physical and chemical factors (such as drug poisoning, alcohol intoxication, carbon monoxide poisoning, etc.), important physical diseases (such as hepatic encephalopathy, pulmonary encephalopathy, etc.), Intracranial mass lesions (e.g., subdural hematoma, brain tumors), endocrine system lesions (e.g., thyroid disease, parathyroid disease), and cognitive impairment due to vitamin deficiency or any other cause; (2) patients with mental illness, including schizophrenia or other psychiatric disorders, bipolar disorder, depression or delirium according to DSM-5 criteria; (3) Other systemic serious diseases; (4) Having uncorrectable visual and hearing impairment and not being able to complete neuropsychological tests and scale assessments; (5) alcohol or drug abusers; (6) Females who are breastfeeding or pregnant (confirmed by urine pregnancy test).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Alzheimer’s Disease-Related Peripheral Blood Biomarkers; | — |
Secondary
| Measure | Time frame |
|---|---|
| Cognitive Status; | — |
Countries
China
Contacts
Public ContactXu Qun
Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine
Outcome results
None listed