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

NCT01453569 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 255

Last updated 2015-01-27

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Shanghai Mental Health Center

    collaborator OTHER

  • Shanghai Greenvalley Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Shifu Xiao, M.D. · Shanghai Mental Health Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2013-08-31
Completion
2013-08-31

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01453569 on ClinicalTrials.gov