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Efficacy and Safety of TMBCZG in Mild to Moderate Vascular Dementia

NCT03230071 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2021-03-02

No results posted yet for this study

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

DRUG

TMBCZG

0.1g per pill which contains 14mg TMBCZG

OTHER

placebo

0.1g per pill which contains 0mg TMBCZG

Sponsors & Collaborators

  • Beijing Union pharmaceutical factory II

    collaborator UNKNOWN

  • Beijing Compete Medical Technology Development Co. Ltd.

    collaborator UNKNOWN

  • Dongzhimen Hospital, Beijing

    lead OTHER

Principal Investigators

  • JinZhou Tian, MD,PhD · Dongzhimen Hospital, Beijing

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-28
Primary Completion
2019-08-22
Completion
2021-02-05

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03230071 on ClinicalTrials.gov