Cognitive dysfunction
Conditions
Interventions
18–30 years age group:None
31-40 years age group:None
41-50 years age group:None
51-60 years age group:None
61-90 years age group:None
Sponsors
Huai’an First People’s Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18–90 years (inclusive); 2. Sex: no restriction; 3. Education level: >=6 years; 4. Able to undergo venous blood sampling (no severe coagulation disorders); 5. Healthy individuals without major underlying diseases; or Patients diagnosed with vascular cognitive impairment (VCI); or Patients diagnosed with type 2 diabetes mellitus with mild cognitive impairment (T2D-MCI), with HbA1c between 7.0% and 10.0%, and stable antidiabetic treatment regimen and dosage for at least 12 weeks prior to enrollment (no new medications or significant dose adjustments); 6. Voluntary participation with signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Use of medications that may affect cognitive function (e.g., antidepressants, antipsychotics) within the past 3 months; 2. History of neurological or psychiatric disorders that may affect cognitive function, including but not limited to Parkinson’s disease, multiple sclerosis, or major psychiatric disorders, as well as significant hearing or visual impairments that may interfere with cognitive assessment; 3. Severe hepatic or renal insufficiency; 4. Participation in other drug clinical trials within the past 3 months prior to screening; 5. Major surgery within 3 months prior to screening, or not fully recovered from surgery; 6. Women of childbearing potential who are unwilling to use medically acceptable and effective contraception from the time of signing informed consent until 4 weeks after the end of the study, or who have a positive pregnancy test at screening or enrollment, or who are pregnant or breastfeeding. Women of childbearing potential are defined as those who have not undergone surgical or chemical sterilization or have not been postmenopausal for at least 12 months; 7. Any other conditions that, in the investigator’s judgment, may affect the study results or lead to premature termination of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum BOD1 levels; | — |
Secondary
| Measure | Time frame |
|---|---|
| Cognitive function scores;Levels of BOD1-related biomarkers (e.g., GLUT1, SASP-related markers);Biochemical parameters;Depression scores; | — |
Countries
China
Contacts
Public ContactHong Zhang
Huai’an First People’s Hospital,
Outcome results
None listed