Vascular DementiaPhase 2NCT03230071

Efficacy and Safety of TMBCZG in Mild to Moderate Vascular Dementia

A Phase 2 study testing TMBCZG in people with Vascular Dementia, run by Dongzhimen Hospital, Beijing at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 55 to 80 years
Conditions the study is for: Vascular Dementia
What is being tested?: TMBCZG
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 160 participants
Where: 1 siteChina
Study dates: 28 Jul 2017to 5 Feb 2021
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 55 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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;

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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.

Who cannot join

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);

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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.

Trial locations and contacts

1 site in 1 country.

China1 site

Dongzhimen Hospital ,Beijing University of Chinese Medicine
Beijing, Beijing Municipality, 100700

Other trials in China

About this study

Official title: 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.

Conditions: Vascular Dementia
Being tested: TMBCZG, placebo
Keywords: Herbal therapy, Randomized controlled trial, Vascular Dementia
Medical subject headings: Dementia, Vascular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TMBCZGDrug
Also called TianMaBianChunZhiGanPian, TianMaYouJiDuoSuanBianZhiGanPian(TMYJDSBZG)
0.1g per pill which contains 14mg TMBCZG
placeboOther
0.1g per pill which contains 0mg TMBCZG

Study groups in NCT03230071
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: TMBCZG; Other: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Vascular Dementia Assessment Scale-cognitive subscale(VADAS-Cog)
Change from baseline to end of double-blind treatment of VADAS-Cog.
Measured: 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.
Measured: baseline, 4-week, 12-week, 24-week and 28-week.

Secondary outcomes (2)

Mini-Mental State Examination (MMSE)
Change from baseline to end of double-blind treatment of MMSE.
Measured: 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.
Measured: baseline, 4-week, 12-week, 24-week and 28-week.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Jul 20175 Feb 2021

First posted26 Jul 2017
Study start28 Jul 2017
Primary completion22 Aug 2019
Study completion5 Feb 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Vascular DementiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 160 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03230071
Sponsor's protocol ID: P2017-03-BDY-03-V03
Status last verified: Feb 2021
First submitted: 24 Jul 2017
Last updated: 2 Mar 2021
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 30572524

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Vascular Dementia trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety of Twice Daily TMBCZG in Mild to Moderate Vascular Dementia: Randomized, Double Blind, Parallel Group, Placebo Controlled, Multicenter Trial
ClinicalTrials.gov ID: NCT03230071
Acronym / sponsor ID: P2017-03-BDY-03-V03
Conditions: Vascular Dementia
Keywords: Herbal therapy, Randomized controlled trial, Vascular Dementia
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 160 participants (actual)
Lead sponsor: Dongzhimen Hospital, BeijingUniversity, hospital or other
Collaborators: Beijing Union pharmaceutical factory II, Beijing Compete Medical Technology Development Co. Ltd.
Study start: 28 Jul 2017 (actual)
Primary completion: 22 Aug 2019 (actual)
Study completion: 5 Feb 2021 (actual)
First posted: 26 Jul 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Placebo	Placebo comparator	Other: placeboplacebo 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	Drug: TMBCZGTMBCZG, 0.1g per pill which contains 14mg TMBCZG, 3 pills per time, 2 times per day for 24 weeks.
TMBCZG-medium dose	Experimental	Drug: TMBCZG, Other: placeboTMBCZG( 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	Drug: TMBCZG, Other: placeboTMBCZG( 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.

Who may qualify

Ages: 55 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

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;

Key exclusion criteria (15 listed)

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);

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TMBCZGAlso: TianMaBianChunZhiGanPian, TianMaYouJiDuoSuanBianZhiGanPian(TMYJDSBZG)0.1g per pill which contains 14mg TMBCZG	Drug	TMBCZG-high dose, TMBCZG-low dose, TMBCZG-medium dose
placebo0.1g per pill which contains 0mg TMBCZG	Other	Placebo, TMBCZG-low dose, TMBCZG-medium dose

Primary outcome

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.
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.

2 secondary outcomes

Mini-Mental State Examination (MMSE)
Time frame: 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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2021.
Derived from this study: PubMed 30572524Tian 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.
Individual participant dataSharing planned: No

Related trials for Vascular Dementia

Active, not recruitingPhase 2
Effect of Equol Supplementation on Arterial Stiffness and Cognition in Healthy Volunteers
Arterial Stiffness, White Matter Lesions
Recruiting
Motor Learning in Health and Movement Disorders: Role of Physical Activity and Advanced Devices
Healthy Individuals (Controls), Parkinson Disease
RecruitingObservational study
China HEalthy Aging and Dementia Study (HEAD)
Alzheimer Disease (AD), Mild Cognitive Impairment (MCI)
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingObservational study
Registry for CADASIL
Cerebral Autosomal Dominant Ateriopathy With Subcortical Infarcts and Leukoencephalopathy

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

JinZhou Tian, MD,PhD study director

Dongzhimen Hospital, Beijing

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TMBCZG in people with Vascular Dementia, run by Dongzhimen Hospital, Beijing at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Vascular Dementia Assessment Scale-cognitive subscale(VADAS-Cog) (time frame: baseline, 4-week, 12-week, 24-week and 28-week.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03230071, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2021.