- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02453932
Efficacy and Safety of Tianzhi Granule in Mild to Moderate Vascular Dementia
January 5, 2020 updated by: Jinzhou Tian, Dongzhimen Hospital, Beijing
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
543
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Beijing
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Beijing, Beijing, China, 100700
- Dongzhimen Hospital,Beijing University of Chinese Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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;
- HIS score of ≥7;
- adequate vision and hearing ability to complete all study tests;
- with a stable caregiver.
Exclusion Criteria:
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;
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Tianzhi granule
Tianzhi granule and placebo identified to donepezil
|
1 pack Tianzhi granule (5g), 3 times per day and placebo identified to donepezil, 1 pill per day for 24 weeks
|
Active Comparator: Donepezil
Donepezil and placebo identified to Tianzhi granule
|
donepezil 5mg per day and placebo identified to Tianzhi granule (5g, 3 times per day) for 24 weeks
|
Placebo Comparator: Placebo
Placebo identified toTianzhi granule and placebo identified to donepezil
|
placebo identified to Tianzhi granule (5g, 3 times per day) and placebo identified to donepezil ,1 pills per day for 24 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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
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
|
week 0, 4, 12, 24
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes of Mini-Mental State Examination(MMSE) from baseline after 24 weeks' treatment
Time Frame: week 0, 4, 12, 24
|
Global cognition will be assessed by the MMSE,which will be conducted at baseline, 4weeks, 12weeks, 24weeks.
|
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
|
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
|
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
|
Executive function and Visuospatial function : the CDT scale will be conducted at baseline, 4weeks, 12weeks, 24weeks.
|
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
|
Executive function: The TMT scale will be conducted at baseline, 4weeks, 12weeks, 24weeks.
|
week 0, 4, 12, 24
|
Changes of Neuropsychiatric Inventory(NPI) from baseline after 24 weeks' intervention
Time Frame: week 0, 4, 12, 24
|
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.
|
week 0, 4, 12, 24
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jinzhou Tian, MD,PhD, Dongzhimen Hospital, Beijing University of Chinese Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2013
Primary Completion (Actual)
May 1, 2017
Study Completion (Actual)
May 1, 2017
Study Registration Dates
First Submitted
May 19, 2015
First Submitted That Met QC Criteria
May 21, 2015
First Posted (Estimate)
May 27, 2015
Study Record Updates
Last Update Posted (Actual)
January 7, 2020
Last Update Submitted That Met QC Criteria
January 5, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Neurocognitive Disorders
- Intracranial Arterial Diseases
- Intracranial Arteriosclerosis
- Leukoencephalopathies
- Dementia
- Dementia, Vascular
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Cholinergic Agents
- Enzyme Inhibitors
- Nootropic Agents
- Cholinesterase Inhibitors
- Donepezil
Other Study ID Numbers
- 2012ZX09104-203
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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