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

Green Valley Pharmaceuticals

Status and phase

Completed

Phase 2

Conditions

Alzheimer Disease

Cognitive Impairment

Treatments

Drug: Sodium oligo-mannurarate 600mg

Drug: Sodium oligo-mannurarate 900mg

Drug: Placebo

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01453569

9712011-1

Details and patient eligibility

About

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.

Full 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 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.

Enrollment

255 patients

Sex

All

Ages

50 to 85 years old

Volunteers

No Healthy Volunteers

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.