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| Name | Class |
|---|---|
| Beijing Union pharmaceutical factory II | UNKNOWN |
| Beijing Compete Medical Technology Development Co. Ltd. | UNKNOWN |
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The study will be a 24-week multicentre, double-blind, placebo-controlled phase â…¡a 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | placebo identified to TMBCZG,0.1g per pill which contains 0mg TMBCZG,3 pills per time, 2 times per day for 24 weeks. |
|
| TMBCZG-high dose | Experimental | TMBCZG, 0.1g per pill which contains 14mg TMBCZG, 3 pills per time, 2 times per day for 24 weeks. |
|
| TMBCZG-medium dose | Experimental | 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. |
|
| TMBCZG-low dose | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TMBCZG | Drug | 0.1g per pill which contains 14mg TMBCZG |
|
| Measure | Description | Time Frame |
|---|---|---|
| Vascular Dementia Assessment Scale-cognitive subscale(VADAS-Cog) | 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) | Change from baseline to end of double-blind treatment of CDR-SB. | baseline, 4-week, 12-week, 24-week and 28-week. |
| Measure | Description | Time Frame |
|---|---|---|
| Mini-Mental State Examination (MMSE) | 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) | Change from baseline to end of double-blind treatment of ADL. |
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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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| JinZhou Tian, MD,PhD | Dongzhimen Hospital, Beijing | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dongzhimen Hospital ,Beijing University of Chinese Medicine | Beijing | Beijing Municipality | 100700 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30572524 | Derived | 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. |
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| ID | Term |
|---|---|
| D015140 | Dementia, Vascular |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| placebo | Other | 0.1g per pill which contains 0mg TMBCZG |
|
| baseline, 4-week, 12-week, 24-week and 28-week. |
| D002537 | Intracranial Arteriosclerosis |
| D020765 | Intracranial Arterial Diseases |
| D003704 | Dementia |
| D056784 | Leukoencephalopathies |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |