Vascular Dementia Clinical Trial
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
Verified date | January 2020 |
Source | Dongzhimen Hospital, Beijing |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This ongoing study aimed to evaluate the efficacy and safety of Tianzhi granule in mild to moderate vascular dementia in a more reasonable design.
Status | Completed |
Enrollment | 543 |
Est. completion date | May 2017 |
Est. primary completion date | May 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 45 Years to 85 Years |
Eligibility |
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-?) 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. |
Country | Name | City | State |
---|---|---|---|
China | Dongzhimen Hospital,Beijing University of Chinese Medicine | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Dongzhimen Hospital, Beijing |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | week 0, 4, 12, 24 | |
Primary | 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 | week 0, 4, 12, 24 | |
Secondary | 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. | week 0, 4, 12, 24 | |
Secondary | 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 | week 0, 4, 12, 24 | |
Secondary | 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. | week 0, 4, 12, 24 | |
Secondary | 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. | week 0, 4, 12, 24 | |
Secondary | 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. | week 0, 4, 12, 24 |
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