NCT03230071

Efficacy and Safety of TMBCZG in Mild to Moderate Vascular Dementia

Efficacy and Safety of Twice Daily TMBCZG in Mild to Moderate Vascular Dementia: Randomized, Double Blind, Parallel Group, Placebo Controlled, Multicenter Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Dongzhimen Hospital, Beijing · Academic / Other
• Sex: All
• Age: 55 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Vascular Dementia

Interventions

Type	Name	Description
DRUG	TMBCZG	0.1g per pill which contains 14mg TMBCZG
OTHER	placebo	0.1g per pill which contains 0mg TMBCZG

Timeline

• Start date: 2017-07-28
• Primary completion: 2019-08-22
• Completion: 2021-02-05
• First posted: 2017-07-26
• Last updated: 2021-03-02

Locations

1 site across 1 country: China