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

September 30, 2011
January 25, 2015
October 2011
August 2013   (final data collection date for primary outcome measure)
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.
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 ]
Complete list of historical versions of study NCT01453569 on ClinicalTrials.gov Archive Site
  • 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.
  • 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 ]
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Alzheimer Disease
  • Cognitive Impairment
  • Drug: Sodium oligo-mannurarate 600mg
    sodium oligo-mannurarate capsule 600mg twice a day for 24 weeks
    Other Name: Sodium oligo-mannurarate low dose
  • Drug: Sodium oligo-mannurarate 900mg
    sodium oligo-mannurarate capsule 900mg twice a day for 24 weeks
    Other Name: Sodium oligo-mannurarate high dose
  • Drug: Placebo
    simulant of sodium oligo-mannurarate capsule
  • Experimental: sodium oligo-mannurarate 900mg
    Intervention: Drug: Sodium oligo-mannurarate 900mg
  • Experimental: sodium oligo-mannurarate 600mg
    Intervention: Drug: Sodium oligo-mannurarate 600mg
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
255
August 2013
August 2013   (final data collection date for primary outcome measure)

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.
Both
50 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01453569
9712011-1
No
Shanghai Greenvalley Pharmaceutical Co., Ltd.
Shanghai Greenvalley Pharmaceutical Co., Ltd.
Shanghai Mental Health Center
Principal Investigator: Shifu Xiao, M.D. Shanghai Mental Health Center
Shanghai Greenvalley Pharmaceutical Co., Ltd.
January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP