Efficacy and Safety of TMBCZG in Mild to Moderate Vascular Dementia

NCT ID: NCT03230071

Last Updated: 2021-03-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-28
• Study Completion Date: 2021-02-05

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.

Conditions

Vascular Dementia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

placebo identified to TMBCZG,0.1g per pill which contains 0mg TMBCZG，3 pills per time, 2 times per day for 24 weeks.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: OTHER

0.1g per pill which contains 0mg TMBCZG

TMBCZG-high dose

TMBCZG, 0.1g per pill which contains 14mg TMBCZG, 3 pills per time, 2 times per day for 24 weeks.

Group Type: EXPERIMENTAL

TMBCZG

Intervention Type: DRUG

0.1g per pill which contains 14mg TMBCZG

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.

Group Type: EXPERIMENTAL

TMBCZG

Intervention Type: DRUG

0.1g per pill which contains 14mg TMBCZG

placebo

Intervention Type: OTHER

0.1g per pill which contains 0mg TMBCZG

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.

Group Type: EXPERIMENTAL

TMBCZG

Intervention Type: DRUG

0.1g per pill which contains 14mg TMBCZG

placebo

Intervention Type: OTHER

0.1g per pill which contains 0mg TMBCZG

Interventions

TMBCZG

0.1g per pill which contains 14mg TMBCZG

Intervention Type: DRUG

placebo

0.1g per pill which contains 0mg TMBCZG

Intervention Type: OTHER

Other Intervention Names

TianMaBianChunZhiGanPian; TianMaYouJiDuoSuanBianZhiGanPian(TMYJDSBZG)

Eligibility 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.

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Union pharmaceutical factory II

UNKNOWN

Sponsor Role: collaborator

Beijing Compete Medical Technology Development Co. Ltd.

UNKNOWN

Sponsor Role: collaborator

Dongzhimen Hospital, Beijing

OTHER

Sponsor Role: lead

Responsible Party

Jinzhou Tian

vice-president

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

JinZhou Tian, MD,PhD

Role: STUDY_DIRECTOR

Dongzhimen Hospital, Beijing

Locations

Dongzhimen Hospital ,Beijing University of Chinese Medicine

Beijing, Beijing Municipality, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 30572524 (View on PubMed)

Other Identifiers

P2017-03-BDY-03-V03

Identifier Type: -

Identifier Source: org_study_id