Vascular DementiaPhase 3NCT02453932

Efficacy and Safety of Tianzhi Granule in Mild to Moderate Vascular Dementia

A Phase 3 study of 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.

Trial summary

This ongoing study aimed to evaluate the efficacy and safety of Tianzhi granule in mild to moderate vascular dementia in a more reasonable design. Read more about this study

Who is it for?: Ages 45 to 85 years
Conditions the study is for: Vascular Dementia
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 543 participants
Where: 1 siteChina
Study dates: Oct 2013to May 2017
Phase: Phase 3
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 45 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Inpatients and outpatients meeting the diagnostic criteria probable VaD established according to the Diagnostic and Statistical Manual of Mental Disorders (fourth edition) （DSM-Ⅳ） and 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,
diagnosis of mild to moderate vascular dementia;
Chinese-speaking patients aged ≥45 and≤85 years old in both gender;
weighing between 45 and 90kg;
fully conscious;
MMSE score of≤26 and ≥14;

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HIS score of ≥7;
adequate vision and hearing ability to complete all study tests;
with a stable caregiver.

Who cannot join

Patients will be excluded from the enrollment if they meet any of the followings:
a medical history of other dementia types, like Alzheimer's disease, Parkinson's disease dementia, Huntington disease, Normal pressure hydrocephalus, et al;
major depression (HAMD for 17 items>17) or psychotic disorder;
acute stage of cerebral hemorrhage or subarachnoid hemorrhage;
hypothyroidism;
drug or alcohol abuse;

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epilepsy history; myasthenia gravis history;
severe cardiovascular disease(severe arrhythmia with heart rate≥100 or≤60 times per min, left bundle branch block, myocardial infarction within 3 months, systolic pressure≥180mmHg or ≤90mmHg);
severe liver or kidney dysfunction (alanine aminotransferase>60 IU/L, aspartate transaminase>60 IU/L or serum creatinine >266μmol/L);
severe asthma or chronic obstructive pulmonary disease;
gastrointestinal tract obstruction or severe peptic ulcer; glaucoma;
administration of cholinesterase inhibitors, memantine or nimodipine in the last month;
use of sympathomimetic agent, antihistamine drug, antianxiety drugs or tranquilizer within 48h before assessment;
use of antipsychotic drugs within 72h before assessment;
participation in other clinical trials; allergic history to any type of medication used in this study.

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: A Phase III, Multicenter, Randomized, Double-blind, Positive /Placebo Controlled, Parallel, Three Arms Study of Tianzhi Granule in Mild to Moderate Vascular Dementia

This ongoing study aimed to evaluate the efficacy and safety of Tianzhi granule in mild to moderate vascular dementia in a more reasonable design.

Read the detailed description

This study is a 24-weeks, multicenter, randomized, double-blind, double- placebo, parallel controlled phase III trial being carried out in 23 centers around China. The study population includes mild to moderate VaD patients (planned a total of 630) aged 45-85 in both gender. Participants will be randomly allocated to TZK (15g/d) and placebo identified to donepezil, donepezil (5mg/d) and placebo identified to TZK, or placebo identified to TZK and placebo identified to donepezil for a 24-weeks double-blind treatment period . The primary outcome measure is change from baseline in the Vascular Dementia Assessment Scale-Cognitive Subscale and Clinician's Interview-Based Impression of Change-Plus carer Interview. The secondary outcomes are changes from baseline in the Mini-Mental State Examination, Activity of Daily Living Scale, Clock Drawing Test, Trail Making Test and Neuropsychiatric Inventory. Safety is being assessed by observing side effects and adverse reaction during the entire treatment period. Statistical analysis will be conducted according to per-protocol population and intend-to-treat population and the safety will be analyzed in safety set.

Conditions: Vascular Dementia
Being tested: Tianzhi granule and placebo identified to donepezil, Donepezil and placebo identified to Tianzhi granule, Placebo
Keywords: Vascular dementia, Tianzhi granule, Herbal medicine, Randomized controlled trial, Three arms
Medical subject headings: Dementia, Vascular

What participants receive

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

Tianzhi granule and placebo identified to donepezilDrug
1 pack Tianzhi granule (5g), 3 times per day and placebo identified to donepezil, 1 pill per day for 24 weeks
Donepezil and placebo identified to Tianzhi granuleDrug
donepezil 5mg per day and placebo identified to Tianzhi granule (5g, 3 times per day) for 24 weeks
PlaceboDrug
placebo identified to Tianzhi granule (5g, 3 times per day) and placebo identified to donepezil ,1 pills per day for 24 weeks

Study groups in NCT02453932
Study group	Role	What they receive
Tianzhi granule	Experimental	Tianzhi granule and placebo identified to donepezil Receives: Drug: Tianzhi granule and placebo identified to donepezil
Donepezil	Active comparator	Donepezil and placebo identified to Tianzhi granule Receives: Drug: Donepezil and placebo identified to Tianzhi granule
Placebo	Placebo comparator	Placebo identified toTianzhi granule and placebo identified to donepezil Receives: Drug: Placebo

What is being measured

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

Changes of Vascular Dementia Assessment Scale-Cognitive Subscale(VADAS-cog) from baseline after 24 weeks' intervention
Cognition : VaDAS-cog is a revision of the ADAS-cog to be a better measure in vascular conditions. The original ADAS-cog developed by Rosen et al., measures cognitive performance by combining ratings of 11 items. The cognitive domains mainly addressed by ADAS-cog are memory (short term), language, ability to orientate (reflects memory), construction/planning of simple designs and performance. In addition to ADAS-cog, the VaDAS-cog comprises additional frontal lobe tests reflecting attention, working memory, executive function, and verbal fluency.The VADAS-cog will conducted at baseline, 4weeks, 12weeks, 24weeks
Measured: week 0, 4, 12, 24
Changes of Clinician's Interview-Based Impression of Change-Plus carer Interview(CIBIC-plus) from baseline after 24 weeks' intervention
Overall clinical response: CIBIC-plus is a 7-point scale which provides an index of clinically important change for dementia patients. It is a global measure of detectable change in concentration, orientation, memory, language, behavior, initiative and activities of daily living, usually requiring separate interviews with patients and caregivers,the CIBIC-plus will be conducted at baseline, 4weeks, 12weeks, 24weeks
Measured: week 0, 4, 12, 24

Secondary outcomes (5)

Changes of Mini-Mental State Examination(MMSE) from baseline after 24 weeks' treatment
Global cognition will be assessed by the MMSE,which will be conducted at baseline, 4weeks, 12weeks, 24weeks.
Measured: week 0, 4, 12, 24
Changes of Activity of Daily Living Scale(ADL) from baseline after 24 week's intervention
Function:The ADL mainly used to measure the basic activities of daily living (or self-care) and the instrumental activities of daily living. The ADL scale can be divided to Physical Self-Maintenance Scale (PSMS) and the instrumental activities of daily living (IADL). The PSMS relate to physical activities, such as toileting, mobility, dressing and bathing , and the IADL contains 8 items ,such as shopping, cooking, doing laundry, handling finances, using telephone, mode of transportation, responsibility for own medication and housekeeping.The ADL wil be conducted baseline, 4weeks, 12weeks, 24weeks
Measured: week 0, 4, 12, 24
Changes of Clock Drawing Test(CDT) from baseline after 24 week's intervention
Executive function and Visuospatial function : the CDT scale will be conducted at baseline, 4weeks, 12weeks, 24weeks.
Measured: week 0, 4, 12, 24
Changes of Trail Making Test (TMT) from baseline after 24 week's intervention
Executive function: The TMT scale will be conducted at baseline, 4weeks, 12weeks, 24weeks.
Measured: week 0, 4, 12, 24
Changes of Neuropsychiatric Inventory(NPI) from baseline after 24 weeks' intervention
Changes in psychological symptom: NPI is used throughout the study to assess changes in psychological symptom,the NPI will be conducted at baseline, 4 weeks, 12 weeks, 24 weeks.
Measured: week 0, 4, 12, 24

Timeline

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

Oct 2013May 2017

First posted27 May 2015 (estimated)
Study startOct 2013
Primary completionMay 2017
Study completionMay 2017

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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 543 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02453932
Sponsor's protocol ID: 2012ZX09104-203
Status last verified: Jan 2020
First submitted: 19 May 2015
Last updated: 7 Jan 2020
Results posted: No
Data monitoring committee: Yes

Publications

Shi J, Wei M, Ni J, Sun F, Sun L, Wang J, Yu T, Wang K, Lv P, Wang Y, Zhang Y, Gao X, Gao X, Luo B, Mao S, Zhang B, Ren X, Yu F, Hu W, Yin P, Wu N, Liu X, Bi Q, Wang Y, Tian J; CHASE Study Group. Tianzhi granule improves cognition and BPSD of vascular dementia: a randomized controlled trial. J Transl Med. 2020 Feb 13;18(1):76. doi: 10.1186/s12967-020-02232-z.
PubMed 32054507

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 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III, Multicenter, Randomized, Double-blind, Positive /Placebo Controlled, Parallel, Three Arms Study of Tianzhi Granule in Mild to Moderate Vascular Dementia
ClinicalTrials.gov ID: NCT02453932
Acronym / sponsor ID: 2012ZX09104-203
Conditions: Vascular Dementia
Keywords: Vascular dementia, Tianzhi granule, Herbal medicine, Randomized controlled trial, Three arms
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 543 participants (actual)
Lead sponsor: Dongzhimen Hospital, BeijingUniversity, hospital or other
Study start: Oct 2013
Primary completion: May 2017 (actual)
Study completion: May 2017 (actual)
First posted: 27 May 2015 (estimated)
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.

This ongoing study aimed to evaluate the efficacy and safety of Tianzhi granule in mild to moderate vascular dementia in a more reasonable design.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Tianzhi granule	Experimental	Drug: Tianzhi granule and placebo identified to donepezilTianzhi granule and placebo identified to donepezil
Donepezil	Active comparator	Drug: Donepezil and placebo identified to Tianzhi granuleDonepezil and placebo identified to Tianzhi granule
Placebo	Placebo comparator	Drug: PlaceboPlacebo identified toTianzhi granule and placebo identified to donepezil

Who may qualify

Ages: 45 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Inpatients and outpatients meeting the diagnostic criteria probable VaD established according to the Diagnostic and Statistical Manual of Mental Disorders (fourth edition) （DSM-Ⅳ） and 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,
diagnosis of mild to moderate vascular dementia;
Chinese-speaking patients aged ≥45 and≤85 years old in both gender;
weighing between 45 and 90kg;
fully conscious;

Key exclusion criteria (15 listed)

a medical history of other dementia types, like Alzheimer's disease, Parkinson's disease dementia, Huntington disease, Normal pressure hydrocephalus, et al;
major depression (HAMD for 17 items>17) or psychotic disorder;
acute stage of cerebral hemorrhage or subarachnoid hemorrhage;
hypothyroidism;
drug or alcohol abuse;

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
Tianzhi granule and placebo identified to donepezil1 pack Tianzhi granule (5g), 3 times per day and placebo identified to donepezil, 1 pill per day for 24 weeks	Drug	Tianzhi granule
Donepezil and placebo identified to Tianzhi granuledonepezil 5mg per day and placebo identified to Tianzhi granule (5g, 3 times per day) for 24 weeks	Drug	Donepezil
Placeboplacebo identified to Tianzhi granule (5g, 3 times per day) and placebo identified to donepezil ,1 pills per day for 24 weeks	Drug	Placebo

Primary outcome

Changes of Vascular Dementia Assessment Scale-Cognitive Subscale(VADAS-cog) from baseline after 24 weeks' intervention
Time frame: week 0, 4, 12, 24
Cognition : VaDAS-cog is a revision of the ADAS-cog to be a better measure in vascular conditions. The original ADAS-cog developed by Rosen et al., measures cognitive performance by combining ratings of 11 items. The cognitive domains mainly addressed by ADAS-cog are memory (short term), language, ability to orientate (reflects memory), construction/planning of simple designs and performance. In addition to ADAS-cog, the VaDAS-cog comprises additional frontal lobe tests reflecting attention, working memory, executive function, and verbal fluency.The VADAS-cog will conducted at baseline, 4weeks, 12weeks, 24weeks
Changes of Clinician's Interview-Based Impression of Change-Plus carer Interview(CIBIC-plus) from baseline after 24 weeks' intervention
Time frame: week 0, 4, 12, 24
Overall clinical response: CIBIC-plus is a 7-point scale which provides an index of clinically important change for dementia patients. It is a global measure of detectable change in concentration, orientation, memory, language, behavior, initiative and activities of daily living, usually requiring separate interviews with patients and caregivers,the CIBIC-plus will be conducted at baseline, 4weeks, 12weeks, 24weeks

5 secondary outcomes

Changes of Mini-Mental State Examination(MMSE) from baseline after 24 weeks' treatment
Time frame: week 0, 4, 12, 24
Changes of Activity of Daily Living Scale(ADL) from baseline after 24 week's intervention
Time frame: week 0, 4, 12, 24
Changes of Clock Drawing Test(CDT) from baseline after 24 week's intervention
Time frame: week 0, 4, 12, 24
Changes of Trail Making Test (TMT) from baseline after 24 week's intervention
Time frame: week 0, 4, 12, 24
Changes of Neuropsychiatric Inventory(NPI) from baseline after 24 weeks' intervention
Time frame: week 0, 4, 12, 24

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 7 Jan 2020.
Derived from this study: PubMed 32054507Shi J, Wei M, Ni J, Sun F, Sun L, Wang J, Yu T, Wang K, Lv P, Wang Y, Zhang Y, Gao X, Gao X, Luo B, Mao S, Zhang B, Ren X, Yu F, Hu W, Yin P, Wu N, Liu X, Bi Q, Wang Y, Tian J; CHASE Study Group. Tianzhi granule improves cognition and BPSD of vascular dementia: a randomized controlled trial. J Transl Med. 2020 Feb 13;18(1):76. doi: 10.1186/s12967-020-02232-z.

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
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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, MD,PhD 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 3 study of 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 9 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 7 Jan 2020. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Changes of Vascular Dementia Assessment Scale-Cognitive Subscale(VADAS-cog) from baseline after 24 weeks' intervention (time frame: week 0, 4, 12, 24). 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 NCT02453932, 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 7 Jan 2020.