Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2025-12-24 @ 4:16 PM
NCT ID:
NCT05583266
Eligibility Criteria:
Inclusion Criteria:
1. Age 45-75 years;
2. CSVD can be seen on MRI, which satisfies one of the following conditions:
* Presence of white matter hyperintensities and Fazekas score ≥2;
* Lacunar Infarction ≥1, with or without white matter hyperintensities;
3. is eligible for Transcranial Doppler (TCD) monitoring;
4. meeting the following clinical manifestations:
* Patients with vascular cognitive impairment (abnormalities in memory and or other cognitive domains lasting at least 3 months) ;
* MoCA ≤22 points; MoCA ≤21 points for primary education and below;
5. independent in daily life (modified mRS ≤2) ;
6. with signed informed consent.
Exclusion Criteria:
1. patients with acute cerebral infarction and acute cerebral hemorrhage;
2. patients with bleeding tendency: including platelet count \< 100 × 10\*9/L, active peptic ulcer, history of intracranial hemorrhage (such as epidural hematoma, subdural haematoma, subarachnoid hemorrhage, cerebral hemorrhage, etc.) , cerebral microbleedings (≥5 cerebral microbleedings) , brain tumor, cancer-related stroke, taking anticoagulant drugs, or using dual antiplatelet therapy;
3. patients who have a history of cognitive impairment caused by other causes, such as normal pressure hydrocephalus, Alzheimer's disease, Parkinson's disease, multiple sclerosis, encephalitis, etc.;
4. patients with acute coronary syndrome and severe coronary arteriosclerosis;
5. patients with severe hepatic insufficiency, renal insufficiency, or severe cardiac insufficiency before randomization (severe hepatic insufficiency refers to ALT ≥2.0 times the upper limit of normal or AST ≥2.0 times the upper limit of normal; severe renal insufficiency refers to CRE ≥1.5 times the upper limit of normal or EGFR \< 40 ml/min/1.73 m2; severe cardiac insufficiency refers to NYHA grade of 3-4) ;
6. patients who are pregnant, lactating or likely to become pregnant and planning to become pregnant;
7. patients with refractory hypertension;
8. patients with known allergic history to pentoxifylline, methylxanthine (such as caffeine, aminophylline, dihydroxypropyltheophylline, etc.) ;
9. patients with use of other vasodilators or circulatory improvers within 1 week (e.g. Cilostazol, Vinpocetine, Dimitamol, Sildenafil, Butylphthalide, Betahistine, Uracillin, Alprostadil, etc.) May stop taking the drug for 1 week before enrolling if criteria are met;
10. Patients using other drugs that affect the safety or efficacy evaluation of the tiral drug and who do not agree to discontinue the drug, such as GLP-1 receptor agonists, Liraglutide, dulasapeptide, risperidone, and exenatide;
11. Patients with other life-threatening or serious diseases with an expected survival of \< 36 months;
12. Patients with contraindications to MRI;
13. Patients who could not cooperate to complete the follow-up;
14. Patients who enrolled in other clinical trials within 30 days.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
75 Years
Study:
NCT05583266
Study Brief:
Protocol Section:
NCT05583266