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

Phase II Study of Sodium Oligo-mannurarate Capsule on Mild to Moderate Alzheimer Disease

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.

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 and tangles in the brain. Currently used treatments offer a small symptomatic benefit. No treatments to delay or halt the progression of the disease are, as of yet, available. The investigators suppose sodium oligo-mannurarate capsule to be effective to halt the progression of the disease.

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.