Status:
NOT_YET_RECRUITING
Tongxinluo Capsule in the Treatment of Cerebral Small Vessel Disease-A Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Study（TOPS-CSVD）
Lead Sponsor:
Fudan University
Conditions:
Cerebral Small Vessel Diseases
Eligibility:
All Genders
50-80 years
Phase:
PHASE4
Brief Summary
Cerebral small vessel disease is a series of clinical, imaging and pathological syndromes caused by various etiologies affecting the arteries, capillaries, venules in the brain. The common causes of c...
Eligibility Criteria
Inclusion
- Age 50-80 years (both inclusive);
- Complaints of cognitive impairment involving memory and/or other cognitive domains for at least 3 months;
- Neither normal nor demented cognitive level according to DSM-V criteria, MMSE scale score ≥20 (elementary school) or ≥24 (junior high school and above); CDR scale score ≥0.5 in at least one domain and overall CDR score ≤1;
- MRI has: ① moderate to severe white matter lesions (deep Fazekas score \> 1 or paraventricular Fazekas score \> 2); Mild white matter hyperintensity (deep Fazekas score = 1 or paraventricular Fazekas score = 2) combined with more than 1 lacunar infarction or more than 3 microbleeds foci. ② Absence of old cortical or watershed infarction, cerebral hemorrhage, hydrocephalus, and other cerebral white matter lesions of definite etiology (e.g., multiple sclerosis, metabolic, toxic, etc.);
- Voluntary participation in the study and willing to sign the Informed Consent Form.
Exclusion
- Previously diagnosed with dementia;
- Acute stroke event within 6 months;
- Previously diagnosed hereditary or inflammatory small vessel disease;
- Presence of congenital mental retardation and severe neurological and psychiatric diseases;
- Illiterate or severe visual or hearing impairment that may prevent patients from cooperating with neuropsychological assessment;
- Relevant depression (Hamilton Depression Scale score ≥ 17 points), or other unrelated serious mental illness (schizophrenia, bipolar disorder or delirium);
- Combined with severe cardiac, pulmonary and renal insufficiency (creatinine \> 2.0 mg/dL or 177 μmol/L), severe hepatic impairment (transaminase more than 3 times of normal value);
- Alcohol abuse, drug abuse or use of drugs affecting cognitive assessment, such as sedatives, hypnotics, nootropic drugs, cholinergic drugs;
- Definitely diagnosed malignant tumor, vital organ failure;
- Previous allergy or intolerance to Tongxinluo ingredients;
- The subject has no stable and reliable caregiver, or the caregiver is unable to help the subject participate in the whole process of the study;
- Patients who have participated in other interventional clinical studies within the last 3 months, or are participating in other interventional clinical studies.
Key Trial Info
Start Date :
October 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
1052 Patients enrolled
Trial Details
Trial ID
NCT06061692
Start Date
October 1 2023
End Date
December 1 2026
Last Update
September 29 2023
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