Efficacy and Safety of TMBCZG in Mild to Moderate Vascular Dementia

NCT03230071 | Completed Phase 2 DMC

• 1 other identifier: P2017-03-BDY-03-V03
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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

Keywords

Herbal therapy; Randomized controlled trial; Vascular Dementia

Outcome Measures

Primary Outcomes (2)

• 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.

Secondary Outcomes (2)

• Mini-Mental State Examination (MMSE)

  baseline, 4-week, 12-week, 24-week and 28-week.

• Activities of daily living (ADL)

  baseline, 4-week, 12-week, 24-week and 28-week.

Study Arms (4)

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.

Other: placebo

TMBCZG-high dose

EXPERIMENTAL

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

Drug: TMBCZG

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.

Drug: TMBCZG; Other: placebo

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.

Drug: TMBCZG; Other: placebo

Interventions

TMBCZG DRUG

0.1g per pill which contains 14mg TMBCZG

Also known as: TianMaBianChunZhiGanPian, TianMaYouJiDuoSuanBianZhiGanPian(TMYJDSBZG)

TMBCZG-high dose; TMBCZG-low dose; TMBCZG-medium dose

placebo OTHER

0.1g per pill which contains 0mg TMBCZG

Placebo; TMBCZG-low dose; TMBCZG-medium dose

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dongzhimen Hospital, Beijing: lead
• Beijing Union pharmaceutical factory II: collaborator
• Beijing Compete Medical Technology Development Co. Ltd.: collaborator

Study Sites (1)

Dongzhimen Hospital ,Beijing University of Chinese Medicine

Beijing, Beijing Municipality, 100700, China

Location

Related Publications (1)

• 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.

  PMID: 30572524 DERIVED

MeSH Terms

Conditions

Dementia, Vascular

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Dementia; Leukoencephalopathies; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• JinZhou Tian, MD,PhD

  Dongzhimen Hospital, Beijing

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: vice-president

Study Record Dates

• First Submitted: July 24, 2017
• First Posted: July 26, 2017
• Study Start: July 28, 2017
• Primary Completion: August 22, 2019
• Study Completion: February 5, 2021
• Last Updated: March 2, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)