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

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dongzhimen Hospital, Beijing
• Collaborator: Hutchison Whampoa Guangzhou Baiyunshan Chinese Medicine Company Limited

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