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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief 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.

Detailed Summary: This study is a 24-weeks, multicenter, randomized, double-blind, double- placebo, parallel controlled phase III trial being carried out in 19 centers around China. The study population includes mild to moderate VaD patients (planned a total of 637) 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 and a 12-weeks follow up period after withdrawal of experimental medication. 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.
Sponsor: Dongzhimen Hospital, Beijing

Current 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, 36 ]
  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 and follow-up
• 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, 36 ]
  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 and follow-up

Original Primary Outcome:

• Changes of Vascular Dementia Assessment Scale-Cognitive Subscale(VADAS-cog) from baseline after 24 weeks' intervention [ Time Frame: 24 weeks ]
  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 and 12weeks after last medication
• Changes of Clinician's Interview-Based Impression of Change-Plus carer Interview(CIBIC-plus) from baseline after 24 weeks' intervention [ Time Frame: 24 weeks ]
  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 and 12weeks after last medication.

Current Secondary Outcome:

• Changes of Mini-Mental State Examination(MMSE) from baseline after 24 weeks' treatment [ Time Frame: week 0, 4, 12, 24, 36 ]
  Global cognition will be assessed by the MMSE,which will be conducted at baseline, 4weeks, 12weeks, 24weeks and follow-up.
• Changes of Activity of Daily Living Scale(ADL) from baseline after 24 week's intervention [ Time Frame: week 0, 4, 12, 24, 36 ]
  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 and follow-up
• Changes of Clock Drawing Test(CDT) from baseline after 24 week's intervention [ Time Frame: week 0, 4, 12, 24, 36 ]
  Executive function and Visuospatial function : the CDT scale will be conducted at baseline, 4weeks, 12weeks, 24weeks and follow-up.
• Changes of Trail Making Test (TMT) from baseline after 24 week's intervention [ Time Frame: week 0, 4, 12, 24, 36 ]
  Executive function: The TMT scale will be conducted at baseline, 4weeks, 12weeks, 24weeks and follow-up.
• Changes of Neuropsychiatric Inventory(NPI) from baseline after 24 weeks' intervention [ Time Frame: week 0, 4, 12, 24, 36 ]
  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, and follow-up.

Original Secondary Outcome:

• Changes of Mini-Mental State Examination(MMSE) from baseline after 24 weeks' treatment [ Time Frame: 24 weeks ]
  Global cognition will be assessed by the MMSE,which will be conducted at baseline, 4weeks, 12weeks, 24weeks and 12weeks after last medication.
• Changes of Activity of Daily Living Scale(ADL) from baseline after 24 week's intervention [ Time Frame: 24 weeks ]
  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 and 12weeks after last medication
• Changes of Clock Drawing Test(CDT) from baseline after 24 week's intervention [ Time Frame: 24 weeks ]
  Executive function and Visuospatial function : the CDT scale will be conducted at baseline, 4weeks, 12weeks, 24weeks and 12weeks after last medication
• Changes of Trail Making Test (TMT) from baseline after 24 week's intervention [ Time Frame: 24 weeks ]
  Executive function: The TMT scale will be conducted at baseline, 4weeks, 12weeks, 24weeks and 12weeks after last medication.
• Changes of Neuropsychiatric Inventory(NPI) from baseline after 24 weeks' intervention [ Time Frame: 24 weeks ]
  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, and 12weeks after last medication.

Dates:
Date Received: May 19, 2015
Date Started: January 2015
Date Completion: December 2017
Last Updated: August 3, 2015
Last Verified: August 2015