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

NCT ID: NCT01761227

Last Updated: 2018-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2015-12-31

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).

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.

Conditions

Vascular Dementia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

Fufangdanshen Tablets

Intervention Type: DRUG

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

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hutchison Whampoa Guangzhou Baiyunshan Chinese Medicine Company Limited

INDUSTRY

Sponsor Role: collaborator

Dongzhimen Hospital, Beijing

OTHER

Sponsor Role: lead

Responsible Party

Jinzhou Tian

Vice precident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jinzhou Tian, Ph.D, M.D

Role: PRINCIPAL_INVESTIGATOR

Dongzhimen Hospital, Beijing

Jing Shi, M.D

Role: PRINCIPAL_INVESTIGATOR

Dongzhimen Hospital, Beijing

Locations

Dongzhimen Hospital ,Beijing University of Chinese Medicine

Beijing, Beijing Municipality, China

Countries

China

References

Tian J, Shi J, Wei M, Qin R, Ni J, Zhang X, Li T, Wang Y. The efficacy and safety of Fufangdanshen tablets (Radix Salviae miltiorrhizae formula tablets) for mild to moderate vascular dementia: a study protocol for a randomized controlled trial. Trials. 2016 Jun 8;17(1):281. doi: 10.1186/s13063-016-1410-5.

Reference Type: DERIVED

PMID: 27266867 (View on PubMed)

Other Identifiers

SFDA【2008】I919

Identifier Type: -

Identifier Source: secondary_id

SFDA2005L01916

Identifier Type: -

Identifier Source: org_study_id