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

NCT01761227 | Completed Phase 2 DMC

• 2 other identifiers: SFDA2005L01916SFDA【2008】I919
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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).

Conditions

Vascular Dementia

Keywords

Vascular dementia; Fufangdanshen Tablets; Randomized Controlled trial; Chinese Medicine

Outcome Measures

Primary Outcomes (2)

• 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

  Global cognition was assessed with the CIBIC-plus, at baseline (day 1 clinic visit) and at 12-week intervals thereafter until week 24.

  24 weeks

• Change in cognitive scores: Alzheimer Disease Assessment Scale-cognitive. subscale (ADAS-cog)

  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.

  24 weeks

Secondary Outcomes (2)

• Change in functional scores: Activities of Daily Living (ADL).

  24 weeks

• Change from baseline to the end of double-blind treatment in Mini-mental state examination (MMSE) scores

  24 weeks

Study Arms (2)

Fufangdanshen Tablets

EXPERIMENTAL

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

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Fufangdanshen Tablets 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

Fufangdanshen Tablets

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dongzhimen Hospital, Beijing: lead
• Hutchison Whampoa Guangzhou Baiyunshan Chinese Medicine Company Limited: collaborator

Study Sites (1)

Dongzhimen Hospital ,Beijing University of Chinese Medicine

Beijing, Beijing Municipality, 100700, China

Location

Related Publications (1)

• 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.

  PMID: 27266867 DERIVED

MeSH Terms

Conditions

Dementia, Vascular

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Dementia; Leukoencephalopathies; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Jinzhou Tian, Ph.D, M.D

  Dongzhimen Hospital, Beijing

  PRINCIPAL INVESTIGATOR

• Jing Shi, M.D

  Dongzhimen Hospital, Beijing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice precident

Study Record Dates

• First Submitted: January 2, 2013
• First Posted: January 4, 2013
• Study Start: September 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: October 23, 2018

Record last verified: 2018-10

Locations

CN (1)