Clinical Trial: The Clinical Trial of Chinese Herbal Medicine SaiLuoTong Capsule
Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Phase 2 Clinical Trial of SaiLuoTong Capsule for Vascular Dementia：A 26-week, Multicentre, Randomized, Double -Blind, Placebo-controlled Trial With a 26-week Open-l
Brief Summary: As a traditional Chinese medicine compound, SaiLuoTong capsule is proven to have beneficial effects on learning and memory ability in animal models of vascular dementia (VaD). The study hypothesis is that SaiLuoTong capsule will be effective in the treatment of patients with VaD and will be well tolerated. The purpose of the study is to determine the efficacy and safety of SaiLuoTong capsule on patients with mild to moderate VaD. The outcome measures include general cognitive function, executive function, daily living skills, and mental behavior changes of symptoms in VaD patients.
Detailed Summary:
Vascular dementia (VaD) is a clinical syndrome of acquired intellectual and functional impairment that results from cerebrovascular diseases. SaiLuoTong capsule is a traditional Chinese medicine compound; it is composed of ginseng extract (the main composition: ginseng total saponins), ginkgo biloba extract (the main composition: YinXingTong ester) and safflower extract (the main composition: the west safflower total glycosides). The function of SaiLuoTong capsule is Yiqi Huoxue and Huayu Tongluo in Chinese traditional medicine theory. Pharmacodynamics studies showed that SaiLuoTong capsule can significantly improve neurological symptoms caused by focal cerebral ischemia in animals, and learning and memory ability in animal models of VaD. Based on these previous evidences, we conduct this study to assess the efficacy and safety of SaiLuoTong capsule in patients with mild to moderate VaD. This study is a phase 2 clinical trial of SaiLuoTong capsule for treatment of vascular dementia. The initial study is a 26-week, multicentre, randomized, double -blind, placebo-controlled study. Patients who complete the initial 26-week trial will be eligible to continue in a 26-week open-label extension study.
The primary and secondary objectives of this study are as following:
Primary Objectives:
- To assess the efficacy of SaiLuoTong capsule on cognitive and global functioning in patients with mild-to-moderate VaD;
- To assess the safety and tolerability of SaiLuoTong capsule in patients with mild-to-moderate VaD.
Secondary Objectives:
- To assess the efficacy of SaiLuoTong capsule in improv
Sponsor: Shineway Pharmaceutical Co.,Ltd
Current Primary Outcome:
- V-ADAS-cog [ Time Frame: weeks 0, 13, 26, 39, and 52 ]The V-ADAS-cog comprises the ADAS-cog plus the Maze and Number Cancellation test to specifically assess executive function.
- ADCS-CGIC [ Time Frame: weeks 0, 13, 26, 39, and 52 ]The ADCS-CGIC involves comparison of data acquisition from both home and clinic and the use of both informant-ratings and self-ratings. Important outcomes include clinical global impressions of change (CGIC) as indicators of clinically meaningful change.
Original Primary Outcome: Changes from baseline to the end of treatment in the Vascular Dementia Assessment Scale cognitive subscale (VaDAS-cog) and Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) [ Time Frame: during the treatment (52weeks) ]
The VADAS-cog includes additional tests reflecting mental speed and executive functions.
The ADCS-CGIC involves comparison of data acquisition from both home and clinic and the use of both informant-ratings and self-ratings. Important outcomes include clinical global impressions of change (CGIC) as indicators of clinically meaningful change.
Current Secondary Outcome:
- ADCS - ADL [ Time Frame: weeks 0, 26, and 52 ]An inventory to assess the patient's ability to do basic activities of daily living and instrumental activities of daily living.
- MMSE [ Time Frame: screening, weeks 0, 26, and 52 ]The MMSE is a global test of cognitive function, for which the total score ranges from 0 to 30, with higher scores indicating lesser severity.
- CDR scale [ Time Frame: screening, weeks 0, 26, and 52 ]The CDR is a numeric scale used to quantify the severity of symptoms of dementia (i.e. its 'stage').
- CLOX [ Time Frame: weeks 0, 26, and 52 ]It was designed to elicit executive impairment and to discriminate it from non-executive constructional failure.
- C-EXIT25 [ Time Frame: weeks 0, 26, and 52 ]The C-EXIT25 is a measure of executive function based on a 15-min interview addressing 25 items related to executive cognition.
- NPI [ Time Frame: weeks 0, 26, and 52 ]The NPI is used to assess neuropsychiatric symptoms. The NPI uses a screening strategy to minimize administration time, examining and scoring only those behavioral domains with positive responses to screening questions.
- CDR-sb [ Time Frame: weeks 0, 26, and 52 ]CDR-sb is the sum of boxes of CDR, with higher scores indicating severer degree of impairment.
Original Secondary Outcome:
- ADCS - ADL (Alzheimer's Disease Cooperative Study-activities of daily living) [ Time Frame: 52 weeks ]An inventory of informant based items to assess activities of daily living and instrumental activities of daily living.
- MMSE (Mini-Mental State Examination) [ Time Frame: 52 weeks ]The Mini Mental State Examination (MMSE) is the most commonly used test for complaints of memory problems. It can be used by clinicians to help diagnose dementia and to help assess its progression and severity.
- CDR (Clinical Dementia Rating) scale [ Time Frame: 52 weeks ]The CDR is a numeric scale used to quantify the severity of symptoms of dementia (i.e. its 'stage').
- CLOX (Clock Drawing Task ) [ Time Frame: 52 weeks ]It was designed to elicit executive impairment and discriminate it from non-executive constructional failure.
- C-EXIT25 (Chinese Version of the Executive Interview 25) [ Time Frame: 52 weeks ]The C-EXIT25 is a potentially feasible and valid bedside tool for assessment of executive cognitive functions in the psychogeriatric population
- NPI(Neuropsychiatric Inventory ) [ Time Frame: 52 weeks ]The NPI is used to assess neuropsychiatric symptoms. The NPI uses a screening strategy to minimize administration time, examining and scoring only those behavioral domains with positive responses to screening questions.
Information By: Shineway Pharmaceutical Co.,Ltd
Dates:
Date Received: October 31, 2013
Date Started: December 2011
Date Completion: July 2014
Last Updated: May 7, 2014
Last Verified: May 2014
- V-ADAS-cog [ Time Frame: weeks 0, 13, 26, 39, and 52 ]
