Efficacy and Safety of Tian Ma Bian Chun Zhi Gan Tablets in Mild to Moderate Vascular Dementia
Status:
Not yet recruiting
Trial end date:
2025-06-01
Target enrollment:
Participant gender:
Summary
The study will be a 36-week multicentre, double-blind, placebo-controlled phase Ⅱb trial in
China. Total 360 participants aged 55-80 years will be randomized to Tian Ma Bian Chun Zhi
Gan group (84mg per day) or to placebo group. The primary endpoint will be Vascular Dementia
Assessment Scale-cognitive subscale and Clinical Dementia Rating-Sum of Boxes. Secondary
outcomes included changes in Mini-Mental State Examination, Clock Drawing Test, Delayed Story
Recall and Ability of Daily Living. Patients' safety will be assessed by recording of adverse
events, clinical examinations, electrocardiography and laboratory tests. The patients,
caregivers, and investigators will be blinded to the treatment allocations.