Efficacy and Safety of TMBCZG in Mild to Moderate Vascular Dementia

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.

Timeline

Start

2017-07-28

Primary completion

2019-08-22

Completion

2021-02-05

Publications

• Tian J, Shi J, Wei M, Li T, Ni J, Zhang X, Zhang M, Li Y, Wang Y. Efficacy and safety of Tianmabianchunzhigan in mild to moderate vascular dementia: Protocol of a randomized controlled IIa trial. Medicine (Baltimore). 2018 Dec;97(51):e13760. doi: 10.1097/MD.0000000000013760.

Drugs

Indications