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

This study has been completed.
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 25, 2015
Last verified: January 2015
  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:


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

Primary Outcome Measures:
  • Change of Alzheimer's Disease Assessment Scale-cognitive Subscale(ADAS-cog)/12 After 24 Wks Treatment of Sodium Oligo-mannurarate Capsule [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Alzheimer's Disease Assessment Scale-cognitive Subscale(ADAS-cog)/12 is the most popular cognitive testing instrument used in clinical trials. It consists of 12 tasks measuring the disturbances of memory, language, praxis, attention and other cognitive abilities which are often referred to as the core symptoms of AD. The total score ranges 0-75, the higher score indicates more severity of the disease. Change after 24 wks treatment was calculated by the week 24 minus week 0 (baseline), and a negative change represents an improvement.


Secondary Outcome Measures:
  • Change of Clinician's Interview-Based Impression of Change Plus(CIBIC-plus) After 24 Wks Treatment of Sodium Oligo-mannurarate Capsule [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Clinician's Interview-Based Impression of Change Plus(CIBIC-plus) is widely used in antidementia drug trials. It comprises Likert scales for disease severity and changes, and written accounts summarizing semistructured interviews evaluating behavior, cognition, and function. The results classified as 7 degrades as: Markedly improved, Moderately improved, Minimally improved, No change, Minimally worse, Moderately worse, and Markedly worse.

  • Change of Alzheimer's Disease Cooperative Study/Activities of Daily(ADCS-ADL) After 24 Wks Treatment of Sodium Oligo-mannurarate Capsule [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Alzheimer's Disease Cooperative Study/Activities of Daily (ADCS-ADL) is a scale assessed the daily activties of AD patients after interviewed the caregiver. The scale mainly assess the eating, walking, writing, bathing and reading, et al of the subject. The total score ranges 0-78, the higher score indicate improvement in daily activities. Change after 24 wks treatment was calculated by the week 24 minus week 0 (baseline), and a positive change represents an improvement.

  • Change of Neuropsychiatric Inventory(NPI) After 24 Wks Treatment of Sodium Oligo-mannurarate Capsule [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Neuropsychiatric Inventory (NPI) is a scale to obtain information on the presence of psychopathology in patient with brain disorders. The NPI was developed for application to patients with AD and other dementias, but it may be useful in the assessment of behavioral changes in other conditions. Twelve behavioral areas included in the NPI will be assessed in this trial: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety and elation/euphoria, et al. The total score ranges 0 to 120, the higher score indicates worse state of the AD patient. Change after 24wks treatmnt was calculated by the week 24 minus week 0 (baseline), and a negative change represents an improvement.


Enrollment: 255
Study Start Date: October 2011
Study Completion Date: August 2013
Primary Completion Date: August 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01453569

  Show 24 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
Results First Received: November 13, 2014
Last Updated: January 25, 2015
Health Authority: China: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 04, 2015