Alzheimer's disease
Conditions
Interventions
Alzheimer's Disease Subjects (AD) Group:None
AD-derived mild cognitive impairment (MCI) group:None
non-AD control subjects (HC) with no cognitive impairment:None
Sponsors
Shanghai City First People's Hospital
Eligibility
Sex/Gender
All
Age
50 Years to 85 Years
Inclusion criteria
Inclusion criteria: Enrollment Requirements for Alzheimer's Disease Subjects (AD) Group All of the following criteria must be met to be eligible: (1) Male or female subjects aged =50 and =85 years; (2) Meet the National Institute of Aging–Alzheimer’s Association (NIA-AA) core clinical criteria for AD dementia. (3) Cognitive function has declined to the extent that it affects life and work and is confirmed by objective cognitive function examination: MMSE scale of illiteracy/primary school/middle school/university requires a score of =22 /23 /24 /26 points, and clinical dementia Scale CDR = 0.5 points (memory items = 0.5 points); (4) At the same time, at least one of the biomarkers of Aß plaque or neuronal damage in the cerebrospinal fluid is positive; (5) Patients must be clinically judged to require CSF collection and be a good candidate for cerebrospinal fluid collection; (6) Volunteers must give informed consent to the study before the experiment and voluntarily sign a written informed consent form; (7) Volunteers can communicate well with the researchers and complete the research in accordance with the research regulations. 3.1.1.2 Enrollment requirements for AD-derived mild cognitive impairment (MCI) group: (1) Male or female subjects aged =50 and =85 years; (2) Meet the core clinical diagnostic criteria for AD-derived cognitive impairment (MCI due to AD) in accordance with the National Institute on Aging-Alzheimer's Association (NIA-AA) guidelines, and objectively detect one or more cognitive domain impairments that do not affect daily work life; (3) MMSE scale of illiteracy/primary school/middle school/university score =22 /23 /24 /26 points, MoCA score =26 points and ADL>60 points; (4) At least one of the biomarkers of Aß or neuronal damage in cerebrospinal fluid is positive; (5) Patients must be clinically judged to require CSF collection and be a good candidate for cerebrospinal fluid collection; (6) Volunteers must give informed consent to the study before the experiment and voluntarily sign a written informed consent form; (7) Volunteers can communicate well with the researchers and complete the research in accordance with the research regulations. 3.1.1.3 Inclusion requirements for non-AD control subjects (HC) with no cognitive impairment: (1) Male or female subjects aged =50 and =85 years; (2) MMSE scale of illiteracy/primary school/middle school/university score>22 /23 /24 /26 points and MoCA>26 points, and CDR=0, diagnosed by clinicians; (3) Patients must be clinically judged to require CSF collection and be a good candidate for cerebrospinal fluid collection; (4) Volunteers must give informed consent to the study before the experiment and voluntarily sign a written informed consent form; (5) Volunteers can communicate well with the researchers and complete the research in accordance with the research regulations.
Exclusion criteria
Exclusion criteria: Participants with any of the following were not eligible for this study: (1) Have a mental disorder (e.g., schizophrenia, bipolar disorder), depression, severe anxiety, hallucinations, etc., or a current neurological, systemic or physical condition (e.g., liver disease, congestive heart failure, severe COPD) that may impair cognition and/or may affect attention span; (2) Mental retardation; (3) Impaired visual and auditory acuity, which affects cognitive test; (4) Clearly diagnosed by other forms of cognitive impairment (such as MCI caused by vascular and infectious diseases, cognitive impairment caused by toxic and systemic diseases, cognitive impairment caused by other neurodegenerative diseases such as epilepsy/Parkinson's, etc.); (5) History of transient ischemic attack (TIA), stroke or seizure within 12 months after screening; History of moderate or more severe traumatic brain injury within the first 2 years; (6) Any immune disease that is not adequately controlled or needs to treat with biological drugs during the study; (7) Cognitive impairment caused by severe depression, cerebral ischemia, stroke, cerebrovascular disease, poisoning, inflammation, sleep/breathing disorders or metabolic disorders, long-term diarrhea or malnutrition (vitamin deficiency), liver and kidney insufficiency, drug abuse, etc.; (8) Have focal neurological symptoms and signs (such as hemiplegia, sensory loss, visual field impairment, etc.) or the following symptoms: gait disorder, epilepsy, behavioral changes; (9) Early extrapyramidal signs (such as dystonia and movement disorders: tremor, chorea-like movements, athetosis, etc.); (10) Have a history of primary immunodeficiency virus infection or positive human immunodeficiency virus (HIV) test or positive neurosyphilis at screening; (11) Participate in other ongoing clinical trials at the same time; (12) Women who are breastfeeding or pregnant; (13) Alcohol or drug abuse; (14) Inability to collect cerebrospinal fluid; (15) Any other clinically significant abnormalities that the investigator believes require further examination or treatment in physical examination, vital signs, laboratory tests, etc., or abnormalities that may interfere with the study or safety.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 5hmC of extracellular vesicles derived from CSF; | — |
Secondary
| Measure | Time frame |
|---|---|
| miRNA levels of extracellular vesicles derived from CSF;proteome levels of cerebrospinal fluid-derived extracellular vesicles;5hmC of peripheral blood-derived extracellular vesicles; | — |
Countries
China
Contacts
Public ContactYaxing Gui
Shanghai City First People's Hospital
Outcome results
None listed