Safety, Efficacy and Dose Titration of Sodium Oligo-mannurarate Capsule on Mild to Moderate Alzheimer's Disease

• Status: Completed
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: All

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 therapeutic dose of sodium oligo-mannurarate capsule.

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

Details

• Lead Sponsor: Shanghai Greenvalley Pharmaceutical Co., Ltd.
• Collaborator: Shanghai Mental Health Center

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.