NCT01453569

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 255 (actual)
• Sponsor: Shanghai Greenvalley Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

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.

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 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.

Conditions

• Alzheimer Disease
• Cognitive Impairment

Interventions

Type	Name	Description
DRUG	Sodium oligo-mannurarate 600mg	sodium oligo-mannurarate capsule 600mg twice a day for 24 weeks
DRUG	Sodium oligo-mannurarate 900mg	sodium oligo-mannurarate capsule 900mg twice a day for 24 weeks
DRUG	Placebo	simulant of sodium oligo-mannurarate capsule

Timeline

• Start date: 2011-10-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2011-10-18
• Last updated: 2015-01-27
• Results posted: 2015-01-27

Locations

24 sites across 1 country: China