The study will be a 24-week multicentre, double-blind, placebo-controlled phase Ⅱa trial with 4 treatment arms in China. Participants aged 55-80 years will be randomized to TMBCZG-high dose(84mg per day), TMBCZG- medium dose(56mg per day), TMBCZG- low dose(28mg per day) or to placebo. The primary endpoint will be VADAS-Cog and CDR-SB. Secondary outcomes included changes in MMSE and ADL. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
160
Dongzhimen Hospital ,Beijing University of Chinese Medicine
Beijing, Beijing Municipality, China
Vascular Dementia Assessment Scale-cognitive subscale(VADAS-Cog)
Change from baseline to end of double-blind treatment of VADAS-Cog.
Time frame: baseline, 4-week, 12-week, 24-week and 28-week.
Clinical Dementia Rating-Sum of Boxes (CDR-SB)
Change from baseline to end of double-blind treatment of CDR-SB.
Time frame: baseline, 4-week, 12-week, 24-week and 28-week.
Mini-Mental State Examination (MMSE)
Change from baseline to end of double-blind treatment of MMSE.
Time frame: baseline, 4-week, 12-week, 24-week and 28-week.
Activities of daily living (ADL)
Change from baseline to end of double-blind treatment of ADL.
Time frame: baseline, 4-week, 12-week, 24-week and 28-week.
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