Clinical trial NCT01761227: Efficacy and Safety of Fufangdanshen Tablets in Mild to Moderate Vascular Dementia
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Vascular Dementia
Keywords: Vascular dementia
Fufangdanshen Tablets
Randomized Controlled trial
Chinese Medicine
Lead sponsor: Dongzhimen Hospital, Beijing
Sponsor class: OTHER
Collaborators: name: Hutchison Whampoa Guangzhou Baiyunshan Chinese Medicine Company Limited
First posted: 2013-01-04
Enrollment: 240
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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
timeFrame: 24 weeks
measure: Change in cognitive scores: Alzheimer Disease Assessment Scale-cognitive. subscale (ADAS-cog)
timeFrame: 24 weeks
Secondary outcomes:
measure: Change in functional scores: Activities of Daily Living (ADL).
timeFrame: 24 weeks
measure: Change from baseline to the end of double-blind treatment in Mini-mental state examination (MMSE) scores
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Dongzhimen Hospital ,Beijing University of Chinese Medicine
state: Beijing
Study officials:
affiliation: Dongzhimen Hospital, Beijing
name: Jinzhou Tian, Ph.D, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Dongzhimen Hospital, Beijing
name: Jing Shi, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.