Efficacy and Safety of TMBCZG in Mild to Moderate Vascular Dementia
Status:
Completed
Trial end date:
2021-02-05
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 2
Details
Lead Sponsor:
Dongzhimen Hospital, Beijing
Collaborators:
Beijing Compete Medical Technology Development Co. Ltd. Beijing Union pharmaceutical factory II