- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03230071
Efficacy and Safety of TMBCZG in Mild to Moderate Vascular Dementia
February 28, 2021 updated by: Jinzhou Tian, Dongzhimen Hospital, Beijing
Efficacy and Safety of Twice Daily TMBCZG in Mild to Moderate Vascular Dementia: Randomized, Double Blind, Parallel Group, Placebo Controlled, Multicenter Trial
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 Overview
Study Type
Interventional
Enrollment (Actual)
160
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100700
- Dongzhimen Hospital ,Beijing University of Chinese Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
55 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Patients meeting the clinical diagnosis of probable vascular dementia(VaD) established according to the National Institute of Neurological Disorders and Stroke and the Association Internationale pour la Recherche et l'Enseignement en Neurosciences (NINDS-AIREN)were eligible to participate:
- Dementia defined by clinical core criteria,
- Cerebrovascular disease, defined by history of stroke, as well as multiple basal ganglia and white matter lacunes, or extensive periventricular white matter lesions( excluded medial temporal lobe atrophy or other special image),
- A relationship between dementia and Cerebrovascular disease, manifested or inferred by the presence of one or more of the following: (a) onset of dementia within 3 months following a recognized stroke; (b) abrupt deterioration in cognitive functions; or fluctuating, stepwise progression of cognitive deficits.
- Mild to Moderate Dementia with MMSE score of ≤26 and ≥11;
- Aged ≥55 and ≤80 years old in both gender;
- Weighing of ≥45kg and ≤90kg;
- Adequate vision and hearing ability to complete all study tests;
- With a stable caregiver.
- Have a certain level of language competence (can read simple articles and write simple sentences);
- Informed consent, signed informed consent by legal guardian.
Exclusion Criteria:
- A medical history of other dementia types, like mixed dementia, Alzheimer's disease, frontotemporal dementia, Parkinson's disease dementia, dementia with Lewy bodies, Huntington disease, et al;
- Subdural hematoma, traffic hydrocephalus, brain tumor, thyroid disease,vitamin deficiency or other diseases which can lead to cognitive impediment;
- Major depression (HAMD≥17) or major anxious(HAMA≥12);
- Subject can't complete related test due to severe neurologic deficits, such as hemiplegia, aphasia, audio-visual disorder and so forth;
- Severe cardiovascular disease(severe arrhythmia, myocardial infarction within 3 months, New York Heart Association Functional Classification III-IV, systolic pressure≥180mmHg or ≤90mmHg);
- Severe liver or kidney dysfunction (alanine aminotransferase or aspartate transaminase is more than 1.5 times the upper limit of normal, or serum creatinine is more than the upper limit of normal);
- Uncontrolled diabetes(glycosylated hemoglobin is more than 2 times the upper limit of normal);
- Asthma, chronic obstructive pulmonary disease, multiple neuritis, myasthenia gravis and muscle atrophy;
- Severe indigestion, gastrointestinal obstruction, gastric and duodenal ulcers and other gastrointestinal disorders that can affect drug absorption;
- A medical history of epileptic history, glaucoma, alcoholism, or psycho-substance abuse;
- Subject has been taking cholinesterase inhibitors, memantine, nimodipine or herbal medicine with function of improving cognition in the past one month;
- Use of sympathomimetic or antihistamines drugs within 48h before assessment;
- Allergic constitution or allergic reactions to experimental drug;
- According to the assessment of the investigator, subject cann't complete the study due to poor compliance or other reasons;
- Subject is participating in other clinical trials or participated in the past 1 month.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
placebo identified to TMBCZG,0.1g
per pill which contains 0mg TMBCZG,3 pills per time, 2 times per day for 24 weeks.
|
0.1g per pill which contains 0mg TMBCZG
|
Experimental: TMBCZG-high dose
TMBCZG, 0.1g per pill which contains 14mg TMBCZG, 3 pills per time, 2 times per day for 24 weeks.
|
0.1g per pill which contains 14mg TMBCZG
Other Names:
|
Experimental: TMBCZG-medium dose
TMBCZG( 0.1g per pill which contains 14mg TMBCZG) and placebo identified to TMBCZG(0.1g
per pill which contains 0mg TMBCZG), 2 TMBCZG pills and 1 placebo pill per time, 2 times per day for 24 weeks.
|
0.1g per pill which contains 0mg TMBCZG
0.1g per pill which contains 14mg TMBCZG
Other Names:
|
Experimental: TMBCZG-low dose
TMBCZG( 0.1g per pill which contains 14mg TMBCZG) and placebo identified to TMBCZG(0.1g
per pill which contains 0mg TMBCZG), 1 TMBCZG pills and 2 placebo pill per time, 2 times per day for 24 weeks.
|
0.1g per pill which contains 0mg TMBCZG
0.1g per pill which contains 14mg TMBCZG
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Vascular Dementia Assessment Scale-cognitive subscale(VADAS-Cog)
Time Frame: baseline, 4-week, 12-week, 24-week and 28-week.
|
Change from baseline to end of double-blind treatment of VADAS-Cog.
|
baseline, 4-week, 12-week, 24-week and 28-week.
|
Clinical Dementia Rating-Sum of Boxes (CDR-SB)
Time Frame: baseline, 4-week, 12-week, 24-week and 28-week.
|
Change from baseline to end of double-blind treatment of CDR-SB.
|
baseline, 4-week, 12-week, 24-week and 28-week.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mini-Mental State Examination (MMSE)
Time Frame: baseline, 4-week, 12-week, 24-week and 28-week.
|
Change from baseline to end of double-blind treatment of MMSE.
|
baseline, 4-week, 12-week, 24-week and 28-week.
|
Activities of daily living (ADL)
Time Frame: baseline, 4-week, 12-week, 24-week and 28-week.
|
Change from baseline to end of double-blind treatment of ADL.
|
baseline, 4-week, 12-week, 24-week and 28-week.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: JinZhou Tian, MD,PhD, Dongzhimen Hospital, Beijing University of Chinese Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 28, 2017
Primary Completion (Actual)
August 22, 2019
Study Completion (Actual)
February 5, 2021
Study Registration Dates
First Submitted
July 24, 2017
First Submitted That Met QC Criteria
July 25, 2017
First Posted (Actual)
July 26, 2017
Study Record Updates
Last Update Posted (Actual)
March 2, 2021
Last Update Submitted That Met QC Criteria
February 28, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Neurocognitive Disorders
- Intracranial Arterial Diseases
- Intracranial Arteriosclerosis
- Leukoencephalopathies
- Dementia
- Dementia, Vascular
Other Study ID Numbers
- P2017-03-BDY-03-V03
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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