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

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ClinicalTrials.gov Identifier: NCT01453569
Recruitment Status : Completed
First Posted : October 18, 2011
Results First Posted : January 27, 2015
Last Update Posted : January 27, 2015
Sponsor:
Collaborator:
Shanghai Mental Health Center
Information provided by (Responsible Party):
Shanghai Greenvalley Pharmaceutical Co., Ltd.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions Alzheimer Disease
Cognitive Impairment
Interventions Drug: Sodium oligo-mannurarate 600mg
Drug: Sodium oligo-mannurarate 900mg
Drug: Placebo
Enrollment 255
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sodium Oligo-mannurarate 900mg Sodium Oligo-mannurarate 600mg Placebo
Hide Arm/Group Description Sodium oligo-mannurarate 900mg: sodium oligo-mannurarate capsule 900mg twice a day for 24 weeks Sodium oligo-mannurarate 600mg: sodium oligo-mannurarate capsule 600mg twice a day for 24 weeks Placebo: simulant of sodium oligo-mannurarate capsule
Period Title: Overall Study
Started 86 84 85
Completed 75 70 78
Not Completed 11 14 7
Arm/Group Title Sodium Oligo-mannurarate 900mg Sodium Oligo-mannurarate 600mg Placebo Total
Hide Arm/Group Description Sodium oligo-mannurarate 900mg: sodium oligo-mannurarate capsule 900mg twice a day for 24 weeks Sodium oligo-mannurarate 600mg: sodium oligo-mannurarate capsule 600mg twice a day for 24 weeks Placebo: simulant of sodium oligo-mannurarate capsule Total of all reporting groups
Overall Number of Baseline Participants 83 76 83 242
Hide Baseline Analysis Population Description
All the treated subjects were evaluated for safety. 2, 8 and 3 subjects were excluded from FAS in placebo, 600 mg and 900 mg group respectively. So the case No. were 83, 76, 83 for placebo, 600 mg and 900 mg group respectively.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 83 participants 76 participants 83 participants 242 participants
70.39  (8.51) 70.26  (8.40) 70.34  (8.13) 70.33  (8.24)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 83 participants 76 participants 83 participants 242 participants
Female
50
  60.2%
41
  53.9%
52
  62.7%
143
  59.1%
Male
33
  39.8%
35
  46.1%
31
  37.3%
99
  40.9%
1.Primary Outcome
Title Change of Alzheimer's Disease Assessment Scale-cognitive Subscale(ADAS-cog)/12 After 24 Wks Treatment of Sodium Oligo-mannurarate Capsule
Hide Description 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.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
85, 84, 86 patients were enrolled, and 2, 8 and 3 subjects were excluded from FAS in placebo, 600 mg and 900 mg group respectively. So the case No. ananlysed were 83, 76, 83 for placebo, 600 mg and 900 mg group respectively.
Arm/Group Title Sodium Oligo-mannurarate 900mg Sodium Oligo-mannurarate 600mg Placebo
Hide Arm/Group Description:
Sodium oligo-mannurarate 900mg: sodium oligo-mannurarate capsule 900mg twice a day for 24 weeks
Sodium oligo-mannurarate 600mg: sodium oligo-mannurarate capsule 600mg twice a day for 24 weeks
Placebo: simulant of sodium oligo-mannurarate capsule
Overall Number of Participants Analyzed 83 76 83
Mean (Standard Error)
Unit of Measure: units on a scale
-2.58  (0.62) -1.39  (0.75) -1.45  (0.77)
2.Secondary Outcome
Title Change of Clinician's Interview-Based Impression of Change Plus(CIBIC-plus) After 24 Wks Treatment of Sodium Oligo-mannurarate Capsule
Hide Description 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.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sodium Oligo-mannurarate 900mg Sodium Oligo-mannurarate 600mg Placebo
Hide Arm/Group Description:
Sodium oligo-mannurarate 900mg: sodium oligo-mannurarate capsule 900mg twice a day for 24 weeks
Sodium oligo-mannurarate 600mg: sodium oligo-mannurarate capsule 600mg twice a day for 24 weeks
Placebo: simulant of sodium oligo-mannurarate capsule
Overall Number of Participants Analyzed 83 76 83
Measure Type: Number
Unit of Measure: participants
Markedly improved 0 2 3
Moderately improved 13 9 6
Minimally improved 29 18 32
No change 35 23 25
Minimally worse 4 21 17
Moderately worse 2 3 0
Markedly worse 0 0 0
3.Secondary Outcome
Title Change of Alzheimer's Disease Cooperative Study/Activities of Daily(ADCS-ADL) After 24 Wks Treatment of Sodium Oligo-mannurarate Capsule
Hide Description 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.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
85, 84, 86 patients were enrolled, and 2, 8 and 3 subjects were excluded from FAS in placebo, 600 mg and 900 mg group respectively. So the case No. ananlysed were 83, 76, 83 for placebo, 600 mg and 900 mg group respectively.
Arm/Group Title Sodium Oligo-mannurarate 900mg Sodium Oligo-mannurarate 600mg Placebo
Hide Arm/Group Description:
Sodium oligo-mannurarate 900mg: sodium oligo-mannurarate capsule 900mg twice a day for 24 weeks
Sodium oligo-mannurarate 600mg: sodium oligo-mannurarate capsule 600mg twice a day for 24 weeks
Placebo: simulant of sodium oligo-mannurarate capsule
Overall Number of Participants Analyzed 83 76 83
Mean (Standard Error)
Unit of Measure: units on a scale
-0.49  (0.91) -0.47  (0.88) -1.06  (0.85)
4.Secondary Outcome
Title Change of Neuropsychiatric Inventory(NPI) After 24 Wks Treatment of Sodium Oligo-mannurarate Capsule
Hide Description 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.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
85, 84, 86 patients were enrolled, and 2, 8 and 3 subjects were excluded from FAS in placebo, 600 mg and 900 mg group respectively. So the case No. ananlysed were 83, 76, 83 for placebo, 600 mg and 900 mg group respectively.
Arm/Group Title Sodium Oligo-mannurarate 900mg Sodium Oligo-mannurarate 600mg Placebo
Hide Arm/Group Description:
Sodium oligo-mannurarate 900mg: sodium oligo-mannurarate capsule 900mg twice a day for 24 weeks
Sodium oligo-mannurarate 600mg: sodium oligo-mannurarate capsule 600mg twice a day for 24 weeks
Placebo: simulant of sodium oligo-mannurarate capsule
Overall Number of Participants Analyzed 83 76 83
Mean (Standard Error)
Unit of Measure: units on a scale
-1.11  (1.22) 0.24  (0.83) -2.08  (0.98)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sodium Oligo-mannurarate 900mg Sodium Oligo-mannurarate 600mg Placebo
Hide Arm/Group Description Sodium oligo-mannurarate 900mg: sodium oligo-mannurarate capsule 900mg twice a day for 24 weeks Sodium oligo-mannurarate 600mg: sodium oligo-mannurarate capsule 600mg twice a day for 24 weeks Placebo: simulant of sodium oligo-mannurarate capsule
All-Cause Mortality
Sodium Oligo-mannurarate 900mg Sodium Oligo-mannurarate 600mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Sodium Oligo-mannurarate 900mg Sodium Oligo-mannurarate 600mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/86 (3.49%)      6/84 (7.14%)      6/85 (7.06%)    
Cardiac disorders       
Implantation of artificial heart pacemaker  0/86 (0.00%)  0 1/84 (1.19%)  1 0/85 (0.00%)  0
Hypertension  1/86 (1.16%)  1 0/84 (0.00%)  0 0/85 (0.00%)  0
Gastrointestinal disorders       
Appendicitis  0/86 (0.00%)  0 0/84 (0.00%)  0 1/85 (1.18%)  1
Emptying disorder of intestine and stomach  0/86 (0.00%)  0 0/84 (0.00%)  0 1/85 (1.18%)  1
General disorders       
Hernia  0/86 (0.00%)  0 1/84 (1.19%)  1 0/85 (0.00%)  0
Chill  0/86 (0.00%)  0 0/84 (0.00%)  0 1/85 (1.18%)  1
Infections and infestations       
Cellulitis  1/86 (1.16%)  1 0/84 (0.00%)  0 0/85 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Osteoarthritis  0/86 (0.00%)  0 0/84 (0.00%)  0 1/85 (1.18%)  1
Compressive fracture of vertebra  0/86 (0.00%)  0 1/84 (1.19%)  1 0/85 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Lung cancer  0/86 (0.00%)  0 1/84 (1.19%)  1 0/85 (0.00%)  0
Nervous system disorders       
Stroke  0/86 (0.00%)  0 0/84 (0.00%)  0 1/85 (1.18%)  1
Paralysis of oculomotor nerve  0/86 (0.00%)  0 0/84 (0.00%)  0 1/85 (1.18%)  1
Cerebral hemorrhage  1/86 (1.16%)  1 0/84 (0.00%)  0 0/85 (0.00%)  0
Psychiatric disorders       
Behavioral and psychiatric symptoms  0/86 (0.00%)  0 1/84 (1.19%)  1 0/85 (0.00%)  0
Vascular disorders       
Subdural hematoma  0/86 (0.00%)  0 1/84 (1.19%)  1 0/85 (0.00%)  0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Sodium Oligo-mannurarate 900mg Sodium Oligo-mannurarate 600mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/86 (3.49%)      12/84 (14.29%)      5/85 (5.88%)    
Ear and labyrinth disorders       
Ear and labyrinth [1]  0/86 (0.00%)  0 1/84 (1.19%)  1 1/85 (1.18%)  1
Gastrointestinal disorders       
Gastrointestinal [1]  1/86 (1.16%)  1 0/84 (0.00%)  0 4/85 (4.71%)  4
Injury, poisoning and procedural complications       
Injuries, toxicosis, complications due to surgery [1]  0/86 (0.00%)  0 1/84 (1.19%)  1 0/85 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Muscular and connective tissue [1]  0/86 (0.00%)  0 1/84 (1.19%)  1 0/85 (0.00%)  0
Nervous system disorders       
CNS disorders [1]  0/86 (0.00%)  0 1/84 (1.19%)  1 0/85 (0.00%)  0
Psychiatric disorders       
Psychiatiric disorders [1]  0/86 (0.00%)  0 5/84 (5.95%)  5 0/85 (0.00%)  0
Reproductive system and breast disorders       
Reproductive system and mammary gland [1]  1/86 (1.16%)  1 0/84 (0.00%)  0 0/85 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Respiratoty system, chest and mediastinum [1]  0/86 (0.00%)  0 1/84 (1.19%)  1 0/85 (0.00%)  0
Skin and subcutaneous tissue disorders       
Dermatologic [1]  1/86 (1.16%)  1 2/84 (2.38%)  2 0/85 (0.00%)  0
[1]
Medication-related AE
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Xianliang Xin
Organization: Shanghai Greenvalley Pharmaceutical Co., Ltd.
Phone: 86 21-50504988 ext 1370
EMail: xinxianliang@hotmail.com
Layout table for additonal information
Responsible Party: Shanghai Greenvalley Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01453569     History of Changes
Other Study ID Numbers: 9712011-1
First Submitted: September 30, 2011
First Posted: October 18, 2011
Results First Submitted: November 13, 2014
Results First Posted: January 27, 2015
Last Update Posted: January 27, 2015