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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Shanghai Mental Health Center
Information provided by (Responsible Party):
Shanghai Greenvalley Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01453569
First received: September 30, 2011
Last updated: January 11, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Alzheimer Disease
Cognitive Impairment
 Drug: Sodium oligo-mannurarate 600mg
Drug: Sodium oligo-mannurarate 900mg
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Phase II Study of Sodium Oligo-mannurarate Capsule on Mild to Moderate Alzheimer Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Shanghai Greenvalley Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • Improvement of Alzheimer's Disease Assessment Scale-cognitive subscale(ADAS-cog)/12 of sodium oligo-mannurarate capsule [ Time Frame: 4 weeks, 12 weeks, 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement of Clinician's Interview-Based Impression of Change Plus(CIBIC-plus) of sodium oligo-mannurarate capsule [ Time Frame: 4 weeks, 12 weeks, 24 weeks ] [ Designated as safety issue: No ]
  • Improvement of Alzheimer's Disease Cooperative Study/Activities of Daily(ADCS-ADL) of sodium oligo-mannurarate capsule [ Time Frame: 4 weeks, 12 weeks, 24 weeks ] [ Designated as safety issue: No ]
  • Improvement of Neuropsychiatric Inventory(NPI) of sodium oligo-mannurarate capsule [ Time Frame: 4 weeks, 12 weeks, 24 weeks ] [ Designated as safety issue: No ]
  • β-Amyloi 40 [ Time Frame: 0 week, 24 weeks ] [ Designated as safety issue: No ]
    Cerebrospinal fluid will be assayed in part of the patients, about 10%.

  • β-Amyloi 42 [ Time Frame: 0 week, 24 weeks ] [ Designated as safety issue: No ]
    Cerebrospinal fluid will be assayed in part of the patients, about 10%.

  • Total Tau Protein [ Time Frame: 0 week, 24 weeks ] [ Designated as safety issue: No ]
    Cerebrospinal fluid will be assayed in part of the patients, about 10%.

  • Phosphorylated Tau Protein [ Time Frame: 0 week, 24 weeks ] [ Designated as safety issue: No ]
    Cerebrospinal fluid will be assayed in part of the patients, about 10%.

  • Glucose metabolism of bilateral temporoparietal cortex [ Time Frame: 0 week, 24 weeks ] [ Designated as safety issue: No ]
    Obtained by Positron Emission Tomography in two sites.

  • Apolipoprotein E Genotype [ Time Frame: -4 weeks ] [ Designated as safety issue: No ]
    To research the change of Aβ40、Aβ42、T-tau、P-tau and glucose metabolism of bilateral temporoparietal cortex in patients of different apoE genotype.


Estimated Enrollment: 252
Study Start Date: October 2011
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: sodium oligo-mannurarate 900mg Drug: Sodium oligo-mannurarate 900mg
sodium oligo-mannurarate capsule 900mg twice a day for 24 weeks
Other Name: Sodium oligo-mannurarate high dose
Experimental: sodium oligo-mannurarate 600mg Drug: Sodium oligo-mannurarate 600mg
sodium oligo-mannurarate capsule 600mg twice a day for 24 weeks
Other Name: Sodium oligo-mannurarate low dose
Placebo Comparator: Placebo Drug: Placebo
simulant 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.

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01453569

  Show 25 Study Locations
Sponsors and Collaborators
Shanghai Greenvalley Pharmaceutical Co., Ltd.
Shanghai Mental Health Center
Investigators
Principal Investigator: Shifu Xiao, M.D. Shanghai Mental Health Center
  More Information

No publications provided

Responsible Party: Shanghai Greenvalley Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01453569     History of Changes
Other Study ID Numbers: 9712011-1
Study First Received: September 30, 2011
Last Updated: January 11, 2013
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Alzheimer Disease
Cognition Disorders
Dementia
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on June 17, 2013