Efficacy and Safety of Fufangdanshen Tablets in Mild to Moderate Vascular Dementia

Sponsor

Dongzhimen Hospital, Beijing (Other)

Overall Status

Completed

CT.gov ID

NCT01761227

Collaborator

Hutchison Whampoa Guangzhou Baiyunshan Chinese Medicine Company Limited (Industry)

240

Enrollment

Location

Arms

Actual Duration (Months)

6.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Purpose: The purpose of this study is to examine the efficacy and safety of Fufangdanshen Tablets in patients with mild to moderate vascular dementia (VaD).

Condition or Disease	Intervention/Treatment	Phase
Vascular Dementia	Drug: Fufangdanshen Tablets Drug: Placebo	Phase 2

Detailed Description

This multicenter, double-blind, placebo-controlled study will evaluate the safety and effectiveness of Fufangdanshen Tablets in patients with vascular dementia. All patients will initially receive placebo for a 2 weeks period and then will receive Fufangdanshen Tablets or placebo for 6 months. The primary measures of effectiveness include the change from baseline to the end of treatment in the ADAS-cog/11 score (Alzheimer's Disease Assessment Scale: sum of 11 cognitive items) and the CIBIC-plus score (Clinician's Interview Based Impression of Change - Plus Caregiver Input). Additional measures of effectiveness include the change from baseline to the end of the treatment in the MMSE score (Mini-mental State Examination), the ADL (Ability of Daily Living) score. Safety evaluations (incidence of adverse events, electrocardiograms (ECGs), physical examinations, laboratory tests) will be performed throughout the study. Patients who complete the double-blind portion of the study will be followed up 12 weeks. Effectiveness will be assessed at 12 weeks, 24weeks and 36 weeks. Safety evaluations (incidence of adverse events, ECGs, physical examinations, laboratory tests) will be performed at 12 weeks, 24weeks and 36 weeks of the study. The study hypothesis is that Fufangdanshen Tablets will be effective in the treatment of patients with vascular dementia and will be well tolerated. Double-blind: Fufangdanshen Tablets: 3 tablets per time, 3 times per day, and placebo : 3 tablets per time, 3 times per day. The placebo has similar smile and appearance as the Fufangdanshen Tablets.

Study Design

Study Type:

Interventional

Actual Enrollment :

240 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

The Safety and Efficacy of Fufangdanshen Tablets in Treatment of Mild to Moderate Vascular Dementia: a 24-week, Double Blind, Randomized, Parallel,Placebo Controlled Trial.

Actual Study Start Date :

Sep 1, 2012

Actual Primary Completion Date :

Dec 1, 2015

Actual Study Completion Date :

Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Fufangdanshen Tablets 1 tablets contains contains tanshinoneⅡA 0.67mg , salvianolic acid B 8.2mg, Panax Notoginsenosides R1 0.53mg, ginsenoside Rb1 3.03mg, ginsenoside Rg1 2.73mg, 3 tablets per time, 3 times per day for 24 weeks	Drug: Fufangdanshen Tablets 1 tablets contains contains tanshinoneⅡA 0.67mg , salvianolic acid B 8.2mg, Panax Notoginsenosides R1 0.53mg, ginsenoside Rb1 3.03mg, ginsenoside Rg1 2.73mg, 3 tablets per time, 3 times per day for 24 weeks
Placebo Comparator: Placebo 3 tablets per time, 3 times per day for 24 weeks. The placebo has similar smile and appearance as the Fufangdanshen Tablets	Drug: Placebo Placebo for 3 tablets per time, 3 times per day for 24 weeks

Arm

Intervention/Treatment

Experimental: Fufangdanshen Tablets

1 tablets contains contains tanshinoneⅡA 0.67mg , salvianolic acid B 8.2mg, Panax Notoginsenosides R1 0.53mg, ginsenoside Rb1 3.03mg, ginsenoside Rg1 2.73mg, 3 tablets per time, 3 times per day for 24 weeks

Drug: Fufangdanshen Tablets

Placebo Comparator: Placebo

3 tablets per time, 3 times per day for 24 weeks. The placebo has similar smile and appearance as the Fufangdanshen Tablets

Drug: Placebo

Placebo for 3 tablets per time, 3 times per day for 24 weeks

Outcome Measures

Primary Outcome Measures

Change from baseline to end of double-blind treatment Clinician's Interview Based Impression of Change - Plus Caregiver Input; Alzheimer Disease Assessment Scale-cognitive subscale [24 weeks]
Global cognition was assessed with the CIBIC-plus, at baseline (day 1 clinic visit) and at 12-week intervals thereafter until week 24.
Change in cognitive scores: Alzheimer Disease Assessment Scale-cognitive. subscale (ADAS-cog) [24 weeks]
Cognition was assessed with the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog), at baseline (day 1 clinic visit) and at 12-week intervals thereafter until week 24.

Secondary Outcome Measures

Change in functional scores: Activities of Daily Living (ADL). [24 weeks]
Functional ability was evaluated with the ADL was evaluated at baseline (day 1 clinic visit), at the mid-study (week 12), and at the endpoint of treatment (week 24).
Change from baseline to the end of double-blind treatment in Mini-mental state examination (MMSE) scores [24 weeks]
Change in global cognition:Mini-mental state examination at baseline (day 1 clinic visit) and at 12-week intervals thereafter until week 24.

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.
Weighing between 45 to 90 kg;
The diagnosis had also to be compatible with the findings from a recent (within last 12 months) magnetic resonance image (MRI) of the brain and
The Hachinski Ischemia Scale (HIS) score>4.
six months' mild to moderate VaD duration before inclusion.
Mild-to-moderate dementia (Score of the Mini-Mental State Examination (MMSE) defined as between 11 to 26)
The Hamilton Depression Scale (HAMD for 17 items) had a score of ≤ 12
have a consistent informant to accompany them on scheduled visits
Ability to read, write, communicate, and understand cognitive testing instructions

Exclusion Criteria:

Neurodegenerative disorders such as Parkinson's disease, with AD and any other secondary types of dementia;
cognitive impairment resulting from conditions such as acute cerebral trauma, cerebral damage due to a lack of oxygen, vitamin deficiency, infections such as meningitis or AIDS, significant endocrine or metabolic disease, mental retardation, or a brain tumor
having significant psychiatric disease, active peptic ulcer, clinically significant liver, kidney or lung disorders, or heart disease
history of epilepsy, convulsions, drug abuse or alcohol abuse
history of hypersensitivity to the treatment drugs;
concomitant drugs with the potential to interfere with cognition;
administration of other investigational drugs;
females of child bearing potential without adequate contraception

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dongzhimen Hospital ,Beijing University of Chinese Medicine	Beijing	Beijing	China	100700

Sponsors and Collaborators

Dongzhimen Hospital, Beijing
Hutchison Whampoa Guangzhou Baiyunshan Chinese Medicine Company Limited

Investigators

Principal Investigator: Jinzhou Tian, Ph.D, M.D, Dongzhimen Hospital, Beijing University of Chinese Medicine
Principal Investigator: Jing Shi, M.D, Dongzhimen Hospital, Beijing University of Chinese Medicine