Vascular DementiaPhase 2NCT01978730
The Clinical Trial of Chinese Herbal Medicine SaiLuoTong Capsule
A Phase 2 study testing high dose group of SaiLuoTong capsule and low dose group of SaiLuoTong in people with Vascular Dementia, run by Shineway Pharmaceutical Co.,Ltd at 16 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Vascular Dementia
- What is being tested?
- high dose group of SaiLuoTong capsule and low dose group of SaiLuoTong
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 372 participants
- Where
- 16 sitesChina
- Study dates
- Dec 2011to Jul 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 40 years old or above, gender is not limited;
- Education≥primary-school;
- Dementia diagnosed according to Diagnostic and Statistical Manual of Mental Disorders-4th Edition (DSM-IV) criteria;
- Probable VaD diagnosed by the National Institute of Neurological Disorders and Stroke-Association Internationale pour la Recherche et l'Enseignement en Neurosciences(NINDS-AIREN) criteria;
- Modified Hachinski ischemic scale(MHIS) total score≥4;
- Evidence of ischemic cerebrovascular disease on magnetic resonance imaging (MRI)and /or CT (corresponding with the imaging criteria of NINDS-AIREN)
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- Mild-to-moderate dementia defined by MMSE score between 10 and 26, CDR score between 1 and 2, both inclusive
- Modified Hachinski ischemic scale(MHIS) total score≥4;
- Hamilton depression scale (HAMD) total score≤17;
- The patients agree to participate in the study and able to understand informed consent as well as signing it. In cases where patients are unable to do so, carer's consent will be obtained as proxy;
- There are carers accompanying patients at least 4 days a week and can accompany patients to participate in each visit.
Who cannot join
- Dementia caused by other brain diseases except VaD (e.g. Alzheimer's disease, Lewy body dementia, frontotemporal dementia, Parkinson's disease, demyelinated disease of the central nervous system, tumour, hydrocephalus, head injury, central nervous system infection including syphilis, acquired immune deficiency syndrome, etc.);
- The patient who can not complete examination because of severe brain or nerve function loss, such as convenient hand hemiplegia, all sorts of aphasia and audio-visual obstacles, etc;
- The presence of abnormal laboratory parameters: Hemoglobin (Hb) and platelet (Plt)less than the lower limit; activated partial thromboplastin time (APTT) beyond the normal value more than 10 seconds, prothrombin time (PT) beyond the normal value more than 3 seconds; creatinine (Cr) more than 1.5 times the upper limit value; alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphates (ALP), γ-glutamyl transferase (γ-GT) more than 2 times the upper limit of normal, total bilirubin (TBiL) more than 1.5 times the upper limit of normal;
- Nutrition metabolic diseases and endocrine system lesions such as thyroid disease, parathyroid diseases,and deficiency of vitamins or other elements;
- Severe circulatory, respiratory, urinary, digestive, hematopoietic system diseases (such as unstable angina, incontrollable asthma, active bleeding, etc.) and cancer;
- Severe mental illness (such as depression, schizophrenia) and epilepsy;
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- Gastrointestinal disorders that affect drug absorption, distribution, and metabolism;
- Alcohol and drug abuse;
- Patients who are using and cannot stop the following drugs including Chinese herba preparation containing ginseng, ginkgo leaf or any component of the saffron; medications that may affect cognitive functioning, such as donepezil, rivastigmine, huperzine A, memantine, nimodipine; etc.;
- Known to be allergic to the composition of SaiLuoTong;
- Pregnancy or breast-feeding women;
- New strokes within 3 months before baseline
- Had participated in other clinical trials before this study 3 months prior to this study.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
China16 sites
The Central Hospital of Baotou
Baotou, Inner Mongolia, 014040
Dongzhimen Hospital affiliated to Beijing University of Chinese Traditional Medicine
Beijing, Beijing Municipality, 100007
Beijing Friendship Hospital of Capital Medical University
Beijing, Beijing Municipality, 100050
Xuan Wu Hospital of Capital Medical University
Beijing, Beijing Municipality, 100053
The First Hospital of Jilin University
Changchun, Jilin, 130021
The Hospital of Traditional Chinese and Western Medicine of Jilin Province
Changchun, Jilin, 132012
The First Hospital of Hunan University of Chinese Traditional Medicine
Changsha, Hunan, 410007
The Affiliated Hospital of Chengdu Chinese Traditional Medicine
Chengdu, Sichuan, 610072
The First people's Hospital of Chenzhou
Chenzhou, Hunan, 423000
The Chinese Traditional Medical Hospital of Guangdong Province
Guangzhou, Guangdong, 510006
Southern Hospital of Southern Medical
Guangzhou, Guangdong, 510515
The First Hospital of Zhejiang University
Hangzhou, Zhejiang, 310003
The Zhongda Hospital of Southeast University
Nanjing, Jiangsu, 210009
Chinese Traditional Medical Hospital of Jiangsu Province
Nanjing, Jiangsu, 210029
The Shuguang Hospital of Shanghai University of Chinese Traditional Medicine
Shanghai, Shanghai Municipality, 201203
The First Hospital of Tianjin University of Chinese Traditional Medicine
Tianjin, Tianjin Municipality, 300193
About this study
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-label Extension
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.
Read the detailed description
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 improving the ability to do activities of daily living, executive function, and neuropsychiatric symptoms in patients with mild-to-moderate VaD;
- To assess the efficacy of different dosage regimens of SaiLuoTong in patients with mild-to-moderate VaD;
- To assess the efficacy of SaiLuoTong treatment of different duration in patients with mild-to-moderate VaD;
- To assess the efficacy of SaiLuoTong capsule on different etiological subtypes of VaD, including large-vessel VaD, small-vessel VaD, and VaD of mixed large-vessel and small-vessel origin;
- To assess the efficacy of SaiLuoTong capsule in mild VaD patients and moderate VaD patients separately;
- To assess to effect of apolipoprotein E (ApoE) ε4 allele on trial outcomes.
The study will assess the changes in cognitive function, daily living skills, executive functions, behavioral and psychological symptoms. The primary measures of effectiveness include the change from baseline in the vascular dementia assessment scale cognitive subscale (V-ADAS-cog) and Alzheimer's disease cooperative study-clinical global impression of change (ADCS-CGIC). Secondary measures of effectiveness include the change from baseline in the Alzheimer's disease cooperative study-activities of daily living inventory (ADCS-ADL), mini-mental state examination (MMSE), clinical dementia rating scale (CDR), sum of boxes of CDR(CDR-sb), clock drawing task (CLOX), Chinese version of executive interview 25 (C-EXIT25) and neuropsychiatric inventory (NPI). Safety measures include physical examinations, vital signs, electrocardiography, laboratory tests, and adverse events records.
- Conditions
- Vascular Dementia
- Being tested
- high dose group of SaiLuoTong capsule, low dose group of SaiLuoTong, the control group
- Keywords
- vascular dementia, cognition, stroke
- Medical subject headings
- Dementia, Vascular, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high dose group of SaiLuoTong capsuleDrug
high dose group of SaiLuoTong capsule: take three pills (180 mg) of SaiLuoTong capsule each time, twice a day, 0.5 hours after breakfast and dinner, taking with lukewarm water.
low dose group of SaiLuoTongDrug
low dose group of SaiLuoTong capsule: take two pills (120 mg) of SaiLuoTong capsule plus one pill of placebo (analog SaiLuoTong capsule) each time, twice a day, 0.5 hours after breakfast and dinner, taking with lukewarm water.
the control groupDrug
The control group is randomly divided into two groups by 1:1. During the first 26 weeks, all subjects will take three pills of placebo each time, twice a day. During the last 26 weeks, the subjects in the placebo group will take two pills of SaiLuoTong plus one pill of placebo or three pills of SaiLuoTong each time, twice a day.
| Study group | Role | What they receive |
|---|---|---|
| high dose group of SaiLuoTong capsule | Experimental | take three pills (180 mg) of SaiLuoTong capsule each time, twice a day, 0.5 hours after breakfast and dinner, taking with lukewarm water. Receives: Drug: high dose group of SaiLuoTong capsule |
| low dose group of SaiLuoTong capsule | Experimental | take two pills (120 mg) of SaiLuoTong capsule plus one pill of placebo (analog SaiLuoTong capsule) each time, twice a day, 0.5 hours after breakfast and dinner, taking with lukewarm water. Receives: Drug: low dose group of SaiLuoTong |
| the control group | Placebo comparator | The control group is randomly divided into two groups by 1:1. During the first 26 weeks, all subjects will take three pills of placebo each time, twice a day. During the last 26 weeks, the subjects in the placebo group will take two pills of SaiLuoTong plus one pill of placebo or three pills of SaiLuoTong each time, twice a day. Receives: Drug: the control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
V-ADAS-cog
The V-ADAS-cog comprises the ADAS-cog plus the Maze and Number Cancellation test to specifically assess executive function.
Measured: weeks 0, 13, 26, 39, and 52
ADCS-CGIC
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.
Measured: weeks 0, 13, 26, 39, and 52
Secondary outcomes (7)
ADCS - ADL
An inventory to assess the patient's ability to do basic activities of daily living and instrumental activities of daily living.
Measured: weeks 0, 26, and 52
MMSE
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.
Measured: screening, weeks 0, 26, and 52
CDR scale
The CDR is a numeric scale used to quantify the severity of symptoms of dementia (i.e. its 'stage').
Measured: screening, weeks 0, 26, and 52
CLOX
It was designed to elicit executive impairment and to discriminate it from non-executive constructional failure.
Measured: weeks 0, 26, and 52
C-EXIT25
The C-EXIT25 is a measure of executive function based on a 15-min interview addressing 25 items related to executive cognition.
Measured: weeks 0, 26, and 52
NPI
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.
Measured: weeks 0, 26, and 52
CDR-sb
CDR-sb is the sum of boxes of CDR, with higher scores indicating severer degree of impairment.
Measured: weeks 0, 26, and 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2013 (estimated)
- Study startDec 2011
- Primary completionJul 2014 (estimated)
- Study completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 372 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shineway Pharmaceutical Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jianping Jia, professor, Principal investigator, the chief of the neurology department, Xuan Wu Hospital of Capital Medical UniversityBaojun Wang, Doctor, Study chair, the chief of of the neurology department, Central Hospital of BaotouYingzhen Xie, Doctor, Study chair, the chief of the neurology department, Dongzhimen HospitalYuangao Liao, Doctor, Study chair, the chief of the neurology department, the First people's Hospital of ChenzhouDongdong Yang, Doctor, Study chair, the chief of the neurology department, the Affiliated Hospital of Chengdu Chinese Traditional MedicineZhijun Zhang, Doctor, Study chair, the chief of the neurology department, Zhongda Hospital of Southeast UniversityYefeng Cai, Master, Study chair, the chief of the neurology department, Chinese Traditional Medical Hospital of Guangdong ProvinceDesheng Zhou, Doctor, Study chair, the chief of the neurology department, First Hospital of Hunan University of Chinese Traditional Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01978730
- Sponsor's protocol ID
- SW001
- Status last verified
- May 2014
- First submitted
- 31 Oct 2013
- Last updated
- 8 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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-label Extension
- ClinicalTrials.gov ID
- NCT01978730
- Acronym / sponsor ID
- SW001
- Conditions
- Vascular Dementia
- Keywords
- vascular dementia, cognition, stroke
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 372 participants (estimated)
- Lead sponsor
- Shineway Pharmaceutical Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 7 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 description
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 improving the ability to do activities of daily living, executive function, and neuropsychiatric symptoms in patients with mild-to-moderate VaD;
- To assess the efficacy of different dosage regimens of SaiLuoTong in patients with mild-to-moderate VaD;
- To assess the efficacy of SaiLuoTong treatment of different duration in patients with mild-to-moderate VaD;
- To assess the efficacy of SaiLuoTong capsule on different etiological subtypes of VaD, including large-vessel VaD, small-vessel VaD, and VaD of mixed large-vessel and small-vessel origin;
- To assess the efficacy of SaiLuoTong capsule in mild VaD patients and moderate VaD patients separately;
- To assess to effect of apolipoprotein E (ApoE) ε4 allele on trial outcomes.
The study will assess the changes in cognitive function, daily living skills, executive functions, behavioral and psychological symptoms. The primary measures of effectiveness include the change from baseline in the vascular dementia assessment scale cognitive subscale (V-ADAS-cog) and Alzheimer's disease cooperative study-clinical global impression of change (ADCS-CGIC). Secondary measures of effectiveness include the change from baseline in the Alzheimer's disease cooperative study-activities of daily living inventory (ADCS-ADL), mini-mental state examination (MMSE), clinical dementia rating scale (CDR), sum of boxes of CDR(CDR-sb), clock drawing task (CLOX), Chinese version of executive interview 25 (C-EXIT25) and neuropsychiatric inventory (NPI). Safety measures include physical examinations, vital signs, electrocardiography, laboratory tests, and adverse events records.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| high dose group of SaiLuoTong capsule | Experimental | Drug: high dose group of SaiLuoTong capsuletake three pills (180 mg) of SaiLuoTong capsule each time, twice a day, 0.5 hours after breakfast and dinner, taking with lukewarm water. |
| low dose group of SaiLuoTong capsule | Experimental | Drug: low dose group of SaiLuoTongtake two pills (120 mg) of SaiLuoTong capsule plus one pill of placebo (analog SaiLuoTong capsule) each time, twice a day, 0.5 hours after breakfast and dinner, taking with lukewarm water. |
| the control group | Placebo comparator | Drug: the control groupThe control group is randomly divided into two groups by 1:1. During the first 26 weeks, all subjects will take three pills of placebo each time, twice a day. During the last 26 weeks, the subjects in the placebo group will take two pills of SaiLuoTong plus one pill of placebo or three pills of SaiLuoTong each time, twice a day. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 40 years old or above, gender is not limited;
- Education≥primary-school;
- Dementia diagnosed according to Diagnostic and Statistical Manual of Mental Disorders-4th Edition (DSM-IV) criteria;
- Probable VaD diagnosed by the National Institute of Neurological Disorders and Stroke-Association Internationale pour la Recherche et l'Enseignement en Neurosciences(NINDS-AIREN) criteria;
- Modified Hachinski ischemic scale(MHIS) total score≥4;
Key exclusion criteria (13 listed)
- Dementia caused by other brain diseases except VaD (e.g. Alzheimer's disease, Lewy body dementia, frontotemporal dementia, Parkinson's disease, demyelinated disease of the central nervous system, tumour, hydrocephalus, head injury, central nervous system infection including syphilis, acquired immune deficiency syndrome, etc.);
- The patient who can not complete examination because of severe brain or nerve function loss, such as convenient hand hemiplegia, all sorts of aphasia and audio-visual obstacles, etc;
- The presence of abnormal laboratory parameters: Hemoglobin (Hb) and platelet (Plt)less than the lower limit; activated partial thromboplastin time (APTT) beyond the normal value more than 10 seconds, prothrombin time (PT) beyond the normal value more than 3 seconds; creatinine (Cr) more than 1.5 times the upper limit value; alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphates (ALP), γ-glutamyl transferase (γ-GT) more than 2 times the upper limit of normal, total bilirubin (TBiL) more than 1.5 times the upper limit of normal;
- Nutrition metabolic diseases and endocrine system lesions such as thyroid disease, parathyroid diseases,and deficiency of vitamins or other elements;
- Severe circulatory, respiratory, urinary, digestive, hematopoietic system diseases (such as unstable angina, incontrollable asthma, active bleeding, etc.) and cancer;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high dose group of SaiLuoTong capsulehigh dose group of SaiLuoTong capsule: take three pills (180 mg) of SaiLuoTong capsule each time, twice a day, 0.5 hours after breakfast and dinner, taking with lukewarm water. | Drug | high dose group of SaiLuoTong capsule |
| low dose group of SaiLuoTonglow dose group of SaiLuoTong capsule: take two pills (120 mg) of SaiLuoTong capsule plus one pill of placebo (analog SaiLuoTong capsule) each time, twice a day, 0.5 hours after breakfast and dinner, taking with lukewarm water. | Drug | low dose group of SaiLuoTong capsule |
| the control groupThe control group is randomly divided into two groups by 1:1. During the first 26 weeks, all subjects will take three pills of placebo each time, twice a day. During the last 26 weeks, the subjects in the placebo group will take two pills of SaiLuoTong plus one pill of placebo or three pills of SaiLuoTong each time, twice a day. | Drug | the control group |
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.
7 secondary outcomes
ADCS - ADL
Time frame: weeks 0, 26, and 52
MMSE
Time frame: screening, weeks 0, 26, and 52
CDR scale
Time frame: screening, weeks 0, 26, and 52
CLOX
Time frame: weeks 0, 26, and 52
C-EXIT25
Time frame: weeks 0, 26, and 52
NPI
Time frame: weeks 0, 26, and 52
CDR-sb
Time frame: weeks 0, 26, and 52
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianping Jia, professor principal investigator
the chief of the neurology department, Xuan Wu Hospital of Capital Medical University
Baojun Wang, Doctor study chair
the chief of of the neurology department, Central Hospital of Baotou
Yingzhen Xie, Doctor study chair
the chief of the neurology department, Dongzhimen Hospital
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing high dose group of SaiLuoTong capsule and low dose group of SaiLuoTong in people with Vascular Dementia, run by Shineway Pharmaceutical Co.,Ltd at 16 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
V-ADAS-cog (time frame: weeks 0, 13, 26, 39, and 52). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2014.