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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Dongzhimen Hospital, Beijing.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Hutchison Whampoa Guangzhou Baiyunshan Chinese Medicine Company Limited
Information provided by (Responsible Party):
Jinzhou Tian, Dongzhimen Hospital, Beijing
ClinicalTrials.gov Identifier:
NCT01761227
First received: January 2, 2013
Last updated: NA
Last verified: February 2009
History: No changes posted
  Purpose

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 Intervention Phase
Vascular Dementia
Drug: Fufangdanshen Tablets
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:


Further study details as provided by Dongzhimen Hospital, Beijing:

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 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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). [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Change in global cognition:Mini-mental state examination at baseline (day 1 clinic visit) and at 12-week intervals thereafter until week 24.


Estimated Enrollment: 240
Study Start Date: September 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   45 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01761227

Contacts
Contact: Jinzhou Tian, Ph.D,MD 86-10-84013380 jztian@hotmail.com

Locations
China, Beijing
Dongzhimen Hospital ,Beijing University of Chinese Medicine Recruiting
Beiing, Beijing, China, 100700
Contact: Jinzhou Tian, Ph.D,M.D    86-10-84013380    jztian@hotmail.com   
Contact: Jing Shi, M.D    86-10-84013380    shijing87@hotmail.com   
Principal Investigator: Jinzhou Tian, Ph.D,M.D         
Principal Investigator: Jing Shi, M.D         
Sub-Investigator: Yingchun Miao, PH.D         
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
  More Information

No publications provided

Responsible Party: Jinzhou Tian, Vice precident, Dongzhimen Hospital, Beijing
ClinicalTrials.gov Identifier: NCT01761227     History of Changes
Other Study ID Numbers: SFDA2005L01916, SFDA【2008】I919
Study First Received: January 2, 2013
Last Updated: January 2, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Dongzhimen Hospital, Beijing:
Vascular dementia
Fufangdanshen Tablets
Randomized Controlled trial
Chinese Medicine

Additional relevant MeSH terms:
Dementia
Dementia, Vascular
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Cerebrovascular Disorders
Intracranial Arteriosclerosis
Intracranial Arterial Diseases
Leukoencephalopathies
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 19, 2014