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Efficacy and Safety of TMBCZG in Mild to Moderate Vascular Dementia

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ClinicalTrials.gov Identifier: NCT03230071
Recruitment Status : Not yet recruiting
First Posted : July 26, 2017
Last Update Posted : July 28, 2017
Sponsor:
Collaborators:
Beijing Union pharmaceutical factory II
Beijing Compete Medical Technology Development Co. Ltd.
Information provided by (Responsible Party):
Jinzhou Tian, Dongzhimen Hospital, Beijing

Brief 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.

Condition or disease Intervention/treatment Phase
Vascular Dementia Drug: TMBCZG Other: placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Twice Daily TMBCZG in Mild to Moderate Vascular Dementia: Randomized, Double Blind, Parallel Group, Placebo Controlled, Multicenter Trial
Estimated Study Start Date : August 1, 2017
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

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.
Other: placebo
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.
Drug: TMBCZG
0.1g per pill which contains 14mg TMBCZG
Other Names:
  • TianMaBianChunZhiGanPian
  • TianMaYouJiDuoSuanBianZhiGanPian(TMYJDSBZG)

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.
Drug: TMBCZG
0.1g per pill which contains 14mg TMBCZG
Other Names:
  • TianMaBianChunZhiGanPian
  • TianMaYouJiDuoSuanBianZhiGanPian(TMYJDSBZG)

Other: placebo
0.1g per pill which contains 0mg TMBCZG

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.
Drug: TMBCZG
0.1g per pill which contains 14mg TMBCZG
Other Names:
  • TianMaBianChunZhiGanPian
  • TianMaYouJiDuoSuanBianZhiGanPian(TMYJDSBZG)

Other: placebo
0.1g per pill which contains 0mg TMBCZG




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   55 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

    1. Dementia defined by clinical core criteria,
    2. 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),
    3. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03230071


Contacts
Contact: JinZhou Tian, MD,PhD 86-10-84013380 jztian@hotmail.com
Contact: Jing Shi, MD shijing87@hotmail.com

Locations
China, Beijing
Dongzhimen Hospital ,Beijing University of Chinese Medicine
Beijing, Beijing, China, 100700
Sponsors and Collaborators
Dongzhimen Hospital, Beijing
Beijing Union pharmaceutical factory II
Beijing Compete Medical Technology Development Co. Ltd.
Investigators
Study Director: JinZhou Tian, MD,PhD Dongzhimen Hospital,Beijing University of Chinese Medicine

Responsible Party: Jinzhou Tian, vice-president, Dongzhimen Hospital, Beijing
ClinicalTrials.gov Identifier: NCT03230071     History of Changes
Other Study ID Numbers: P2017-03-BDY-03-V03
First Posted: July 26, 2017    Key Record Dates
Last Update Posted: July 28, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jinzhou Tian, Dongzhimen Hospital, Beijing:
Herbal therapy
Randomized controlled trial
Vascular Dementia

Additional relevant MeSH terms:
Dementia
Dementia, Vascular
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Cerebrovascular Disorders
Intracranial Arteriosclerosis
Intracranial Arterial Diseases
Leukoencephalopathies
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases