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

Dongzhimen Hospital, Beijing543 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

543

Conditions

Vascular Dementia

Interventions

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

Eligibility

Sex: ALLMin age: 45 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Locations (1)

Dongzhimen Hospital,Beijing University of Chinese Medicine

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: week 0, 4, 12, 24

Secondary Outcomes

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.

Time frame: 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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.