Status:
COMPLETED
Safety, Efficacy and Dose Titration of Sodium Oligo-mannurarate Capsule on Mild to Moderate Alzheimer's Disease
Lead Sponsor:
Shanghai Greenvalley Pharmaceutical Co., Ltd.
Collaborating Sponsors:
Shanghai Mental Health Center
Conditions:
Alzheimer Disease
Cognitive Impairment
Eligibility:
All Genders
50-85 years
Phase:
PHASE2
Brief Summary
The primary purpose of this study is to determine whether sodium oligo-mannurarate capsule is effective and safe in the treatment of mild to moderate alzheimer' disease, and to determine the best ther...
Detailed Description
Alzheimer's disease is known for placing a great burden on caregivers which includes social, psychological, physical or economic aspects. Research indicates that the disease is associated with plaques...
Eligibility Criteria
Inclusion
- At least primarily educated.
- Accord with Probable Alzheimer disease of National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association(NINCDS-ADRDA)'s Criteria.
- 10 points ≤ Minimum Mean-Square Error(MMSE) ≤ 24 points.
- Hachinski ischemia scale \<4 points.
- Hamilton depression scale ≤10 points.
- Should have stable accompanying person, or at least contact 2 hours per day, 4 days per week with accompanying person. The accompanying person should help the patient throughout the trial.
- Signed the information consent form.
Exclusion
- Have been in other clinical trials within 30 days before this trial' start.
- women during pregnancy or lactation.
- Dementia caused by other diseases.
- previous nervous system diseases.
- Abnormal laboratory results.
- Uncontrolled hypertension.
- Unstable or serious diseases of heart, lung, liver, kidney and blood.
- Visual or auditory handicap.
- Significant focal lesions revealed by electronic computer X-ray tomography(CT) or magnetic resonance imaging(MRI) in one year before enrollment.
- Alcohol abuse or drug abuse.
- psychotic, including patients with serious depression.
- Patients being in drug therapy of Alzheimer disease which cannot be stopped.
- In treatment of heparin, Polysaccharide sulfate, mannose ester 3 weeks before the recruitment.
- Investigator consider the patient cannot finish this trial for any reason.
- Relatives or employees of the investigators, staff of the investigate centers, contract research organization and sponsor.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
255 Patients enrolled
Trial Details
Trial ID
NCT01453569
Start Date
October 1 2011
End Date
August 1 2013
Last Update
January 27 2015
Active Locations (24)
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1
Beijing Hospital
Beijing, Beijing Municipality, China, 100005
2
Chongqing Medical University Second Affiliated Hospital
Chongqing, Chongqing Municipality, China, 400010
3
The First Affliated Hospital of Third Military Medical University
Chongqing, Chongqing Municipality, China, 400038
4
The Third Affliated Hospital of Third Military Medical University
Chongqing, Chongqing Municipality, China, 400042