Vascular DementiaPhase 2NCT05371639
Efficacy and Safety of Tian Ma Bian Chun Zhi Gan Tablets in Mild to Moderate Vascular Dementia
A Phase 2 study testing Tian Ma Bian Chun Zhi Gan Tablets in people with Vascular Dementia and Cognitive Impairment, run by Dongzhimen Hospital, Beijing at 1 site in China.
Trial summary
The study will be a 36-week multicentre, double-blind, placebo-controlled phase Ⅱb trial in China. Total 360 participants aged 55-80 years will be randomized to Tian Ma Bian Chun Zhi Gan group (84mg per day) or to placebo group. Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Vascular Dementia, Cognitive Impairment
- What is being tested?
- Tian Ma Bian Chun Zhi Gan Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 360 participants
- Where
- 1 siteChina
- Study dates
- 25 May 2022to Jun 2025
- 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
- Concerns of a patient, knowledgeable informant or a clinician of decline from a previous level of cognitive functioning.
- Clear and significant deficits in objective assessment in two or more cognitive domains, Memory decline, delayed story recall ≤10.5point(maximum is 56 point), or visuoconstructional-perceptual ability, clock drawing test≤3point(maximum is 4 point);or executive function, trail making test-part B≥188.5 second( maximun is 300 second); or language function, boston naming test-30 items ≤21.5 point( maximum is 30);
- Global cognitive impairment, mild to moderate dementia with Mini-mental state examination(MMSE) score of ≤26 and ≥11;
- Cognitive deficits are severe enough to impair social or occupational functioning, the ability of daily living scale ≥16 points;
- Determining evidence of significant cerebrovascular disease, presence of significant neuroimaging (MRI or CT) evidence of cerebrovascular disease (one of the following): a) multiple (≥2) large vessel infarcts ; b) Single lacunes placed strategically in the thalamus or basal ganglia; c) Multiple lacunar infarcts (≥3) outside the brainstem; d) 1-2 lacunes may be sufficient if strategically placed or in combination with extensive white matter lesions; e) extensive and confluent white matter lesions; f) watershed infarction with moderate white matter lesions; g) Strategically placed intracerebral hemorrhage, or two or more intracerebral hemorrhages; h) combination of the above.
- A relationship between dementia and cerebro-vascular disease, manifested or inferred by the presence of one or more of the following: a) abrupt deterioration in cognitive functions, the onset of the cognitive deficits is temporally related to one or more cerebro-vascular events , onset of cognitive deficits within 3 months following a recognized stroke, and cognitive deficits persisting beyond three months after the event, and abrupt with a stepwise or fluctuating course owing to multiple such events; b) gradual onset and slowly progressive course, evidence for decline is prominent in speed of information processing, complex attention and/or frontal-executive functioning in the absence of history of a stroke or transient ischemic attack. One of the following features is additionally present: ①Early presence of a gait disturbance; ②Early urinary frequency, urgency, and other urinary symptoms not explained by urologic disease; ③Personality and mood changes: abulia, depression, or emotional incontinence
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- 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.
- Informed consent, signed informed consent by legal guardian.
Who cannot join
- Have cognitive impairment caused by other types of dementia, mix dementia, Alzheimer's disease(Medial temporal atrophy scale (MTA) score is ≥1.5 (adjusted by age: 65-74 years ≥ 1.5, 75-84 years ≥ 2.0) at baseline MRI screening),frontotemporal dementia, Parkinson's disease dementia, Lewy body dementia, Huntington's disease, etc;
- Subdural hematoma, traffic hydrocephalus, brain tumor, thyroid disease,vitamin deficiency or other diseases which can lead to cognitive impediment;
- mood disorders, like depression disorder (HAMD≥17) or anxiety disorder (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 10%);
- 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;
- History of taking cholinesterase inhibitors, memantine, or proprietary Chinese medicines with clear nootropic effects for the last 1 month;
- Have taken medications (e.g., antidepressants, benzodiazepines) that affect the central nervous system (CNS), except those for AD, less than 4 weeks；
- History of hypersensitivity to the treatment drugs;
- Participate in other clinical study for the last 1 month;
- Have metal (ferromagnetic) implants, or a cardiac pacemaker and other conditions that make MRI scan not applicable;
- Or any other conditions that, in the investigator's opinion, could interfere with the analyses of safety and efficacy in this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
dongzhimmen Hospital, Beijing University of Chinese medicine
Beijing, Beijing Municipality, 100700
Jing Shi, Dr., shijing87@hotmail.com
About this study
Official title: Efficacy and Safety of Tian Ma Bian Chun Zhi Gan Tablets in the Treatment of Mild to Moderate Vascular Dementia: a Randomized, Placebo Controlled, Double Blind, Parallel Group, Multicenter Trial
The study will be a 36-week multicentre, double-blind, placebo-controlled phase Ⅱb trial in China. Total 360 participants aged 55-80 years will be randomized to Tian Ma Bian Chun Zhi Gan group (84mg per day) or to placebo group. The primary endpoint will be Vascular Dementia Assessment Scale-cognitive subscale and Clinical Dementia Rating-Sum of Boxes. Secondary outcomes included changes in Mini-Mental State Examination, Clock Drawing Test, Delayed Story Recall and Ability of Daily Living. 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, Cognitive Impairment
- Being tested
- Tian Ma Bian Chun Zhi Gan Tablets, Placebo
- Keywords
- Vascular dementia, Cognitive impairment, Tian Ma Bian Chun Zhi Gan, Randomized clinical trial
- Medical subject headings
- Dementia, Vascular, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tian Ma Bian Chun Zhi Gan TabletsDrug
Tian Ma Bian Chun Zhi Gan Tablets, 0.1g per pill which contains 14mg Tian Ma Bian Chun Zhi Gan, 3 pills per time, 2 times per day for 36 weeks.
PlaceboDrug
Placebo identified to Tian Ma Bian Chun Zhi Gan, 0.1g per pill which contains 0mg Tian Ma Bian Chun Zhi Gan, 3 pills per time, 2 times per day for 36 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Tian Ma Bian Chun Zhi Gan group | Experimental | Tian Ma Bian Chun Zhi Gan tablets Receives: Drug: Tian Ma Bian Chun Zhi Gan Tablets |
| Placebo group | Placebo comparator | placebo identified to Tian Ma Bian Chun Zhi Gan tablets Receives: Drug: 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. VADAS-cog is a revision of the ADAS-cog to be a better measure in vascular conditions, and a higher score indicates higher impairment. In addition to ADAS-cog, the VADAS-cog comprises additional frontal lobe tests reflecting attention, working memory, executive function, and verbal fluency.
Measured: Baseline, 12-week, 24-week and 36-week.
Clinical Dementia Rating-Sum of Boxes (CDR-SB)
Change from baseline to end of double-blind treatment of CDR-SB.The CDR-SB is a standard for disease grading in clinical studies of dementia and is used for overall endpoint assessment in clinical trials. It comprehensively assesses the cognitive and functional aspects of dementia patients, including memory, orientation, judgment and problem-solving skills, social affairs, family and hobbies, and personal cooking. The CDR-SB scores from 0 to 18 points, and a higher score indicates higher impairment.
Measured: Baseline, 12-week, 24-week and 36-week.
Secondary outcomes (4)
Mini-Mental State Examination (MMSE)
Change from baseline to end of double-blind treatment of MMSE. MMSE was used to evaluate global cognition, The maximum score for the MMSE is 30, lower score means severe impairment.
Measured: Baseline, 12-week, 24-week and 36-week.
Clock drawing test (CDT)
The changes of the CDT from baseline after 36 weeks treatment. Executive function is assessed by CDT, the maximum score of CDT is 4 points.
Measured: Baseline, 12-week, 24-week and 36-week.
Activities of daily living (ADL)
Change from baseline to end of double-blind treatment of ADL. ADL scale is used to measure the physical self-maintenance ability and instrumental activities of daily living ability.
Measured: Baseline, 12-week, 24-week and 36-week.
Delayed story recall (DSR)
Change from baseline to end of double-blind treatment of DSR. DSR is used to eveluate the memory function, which scores range from 0 to 56.
Measured: Baseline, 12-week, 24-week and 36-week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2022
- Study start25 May 2022
- Primary completionDec 2024 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dongzhimen Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jinzhou Tian, Dongzhimen Hospital, Beijing
- Investigators
- Jinzhou Tian, Principal investigator, Dongzhimen Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05371639
- Sponsor's protocol ID
- YHNK-XY-2-2021-01
- Status last verified
- Nov 2022
- First submitted
- 9 May 2022
- Last updated
- 22 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Tian Ma Bian Chun Zhi Gan Tablets in the Treatment of Mild to Moderate Vascular Dementia: a Randomized, Placebo Controlled, Double Blind, Parallel Group, Multicenter Trial
- ClinicalTrials.gov ID
- NCT05371639
- Acronym / sponsor ID
- YHNK-XY-2-2021-01
- Conditions
- Vascular Dementia, Cognitive Impairment
- Keywords
- Vascular dementia, Cognitive impairment, Tian Ma Bian Chun Zhi Gan, Randomized clinical trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Dongzhimen Hospital, BeijingUniversity, hospital or other
- Study start
- 25 May 2022 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 12 May 2022 (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.
The study will be a 36-week multicentre, double-blind, placebo-controlled phase Ⅱb trial in China. Total 360 participants aged 55-80 years will be randomized to Tian Ma Bian Chun Zhi Gan group (84mg per day) or to placebo group. The primary endpoint will be Vascular Dementia Assessment Scale-cognitive subscale and Clinical Dementia Rating-Sum of Boxes. Secondary outcomes included changes in Mini-Mental State Examination, Clock Drawing Test, Delayed Story Recall and Ability of Daily Living. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tian Ma Bian Chun Zhi Gan group | Experimental | Drug: Tian Ma Bian Chun Zhi Gan TabletsTian Ma Bian Chun Zhi Gan tablets |
| Placebo group | Placebo comparator | Drug: Placeboplacebo identified to Tian Ma Bian Chun Zhi Gan tablets |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Concerns of a patient, knowledgeable informant or a clinician of decline from a previous level of cognitive functioning.
- Clear and significant deficits in objective assessment in two or more cognitive domains, Memory decline, delayed story recall ≤10.5point(maximum is 56 point), or visuoconstructional-perceptual ability, clock drawing test≤3point(maximum is 4 point);or executive function, trail making test-part B≥188.5 second( maximun is 300 second); or language function, boston naming test-30 items ≤21.5 point( maximum is 30);
- Global cognitive impairment, mild to moderate dementia with Mini-mental state examination(MMSE) score of ≤26 and ≥11;
- Cognitive deficits are severe enough to impair social or occupational functioning, the ability of daily living scale ≥16 points;
- Determining evidence of significant cerebrovascular disease, presence of significant neuroimaging (MRI or CT) evidence of cerebrovascular disease (one of the following): a) multiple (≥2) large vessel infarcts ; b) Single lacunes placed strategically in the thalamus or basal ganglia; c) Multiple lacunar infarcts (≥3) outside the brainstem; d) 1-2 lacunes may be sufficient if strategically placed or in combination with extensive white matter lesions; e) extensive and confluent white matter lesions; f) watershed infarction with moderate white matter lesions; g) Strategically placed intracerebral hemorrhage, or two or more intracerebral hemorrhages; h) combination of the above.
Key exclusion criteria (16 listed)
- Have cognitive impairment caused by other types of dementia, mix dementia, Alzheimer's disease(Medial temporal atrophy scale (MTA) score is ≥1.5 (adjusted by age: 65-74 years ≥ 1.5, 75-84 years ≥ 2.0) at baseline MRI screening),frontotemporal dementia, Parkinson's disease dementia, Lewy body dementia, Huntington's disease, etc;
- Subdural hematoma, traffic hydrocephalus, brain tumor, thyroid disease,vitamin deficiency or other diseases which can lead to cognitive impediment;
- mood disorders, like depression disorder (HAMD≥17) or anxiety disorder (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 |
|---|---|---|
| Tian Ma Bian Chun Zhi Gan TabletsTian Ma Bian Chun Zhi Gan Tablets, 0.1g per pill which contains 14mg Tian Ma Bian Chun Zhi Gan, 3 pills per time, 2 times per day for 36 weeks. | Drug | Tian Ma Bian Chun Zhi Gan group |
| PlaceboPlacebo identified to Tian Ma Bian Chun Zhi Gan, 0.1g per pill which contains 0mg Tian Ma Bian Chun Zhi Gan, 3 pills per time, 2 times per day for 36 weeks. | Drug | Placebo group |
Primary outcome
Vascular Dementia Assessment Scale-cognitive subscale(VADAS-Cog)
Time frame: Baseline, 12-week, 24-week and 36-week.
Change from baseline to end of double-blind treatment of VADAS-Cog. VADAS-cog is a revision of the ADAS-cog to be a better measure in vascular conditions, and a higher score indicates higher impairment. In addition to ADAS-cog, the VADAS-cog comprises additional frontal lobe tests reflecting attention, working memory, executive function, and verbal fluency.
Clinical Dementia Rating-Sum of Boxes (CDR-SB)
Time frame: Baseline, 12-week, 24-week and 36-week.
Change from baseline to end of double-blind treatment of CDR-SB.The CDR-SB is a standard for disease grading in clinical studies of dementia and is used for overall endpoint assessment in clinical trials. It comprehensively assesses the cognitive and functional aspects of dementia patients, including memory, orientation, judgment and problem-solving skills, social affairs, family and hobbies, and personal cooking. The CDR-SB scores from 0 to 18 points, and a higher score indicates higher impairment.
4 secondary outcomes
Mini-Mental State Examination (MMSE)
Time frame: Baseline, 12-week, 24-week and 36-week.
Clock drawing test (CDT)
Time frame: Baseline, 12-week, 24-week and 36-week.
Activities of daily living (ADL)
Time frame: Baseline, 12-week, 24-week and 36-week.
Delayed story recall (DSR)
Time frame: Baseline, 12-week, 24-week and 36-week.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2022.
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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 principal investigator
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 Tian Ma Bian Chun Zhi Gan Tablets in people with Vascular Dementia and Cognitive Impairment, 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 16 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: status not confirmed, as of the sponsor's last update on 22 Nov 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jinzhou Tian (+861084013380, jztian@hotmail.com), or a site near the patient. 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, 12-week, 24-week and 36-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?
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 22 Nov 2022.