Trial Outcomes & Findings for Safety, Efficacy and Dose Titration of Sodium Oligo-mannurarate Capsule on Mild to Moderate Alzheimer's Disease (NCT NCT01453569)
NCT ID: NCT01453569
Last Updated: 2015-01-27
Results Overview
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.
COMPLETED
PHASE2
255 participants
24 weeks
2015-01-27
Participant Flow
Participant milestones
| Measure |
Sodium Oligo-mannurarate 900mg
Sodium oligo-mannurarate 900mg: sodium oligo-mannurarate capsule 900mg twice a day for 24 weeks
|
Sodium Oligo-mannurarate 600mg
Sodium oligo-mannurarate 600mg: sodium oligo-mannurarate capsule 600mg twice a day for 24 weeks
|
Placebo
Placebo: simulant of sodium oligo-mannurarate capsule
|
|---|---|---|---|
|
Overall Study
STARTED
|
86
|
84
|
85
|
|
Overall Study
COMPLETED
|
75
|
70
|
78
|
|
Overall Study
NOT COMPLETED
|
11
|
14
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety, Efficacy and Dose Titration of Sodium Oligo-mannurarate Capsule on Mild to Moderate Alzheimer's Disease
Baseline characteristics by cohort
| Measure |
Sodium Oligo-mannurarate 900mg
n=83 Participants
Sodium oligo-mannurarate 900mg: sodium oligo-mannurarate capsule 900mg twice a day for 24 weeks
|
Sodium Oligo-mannurarate 600mg
n=76 Participants
Sodium oligo-mannurarate 600mg: sodium oligo-mannurarate capsule 600mg twice a day for 24 weeks
|
Placebo
n=83 Participants
Placebo: simulant of sodium oligo-mannurarate capsule
|
Total
n=242 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
70.39 years
STANDARD_DEVIATION 8.51 • n=5 Participants
|
70.26 years
STANDARD_DEVIATION 8.40 • n=7 Participants
|
70.34 years
STANDARD_DEVIATION 8.13 • n=5 Participants
|
70.33 years
STANDARD_DEVIATION 8.24 • n=4 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
143 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
99 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Sodium Oligo-mannurarate 900mg
n=83 Participants
Sodium oligo-mannurarate 900mg: sodium oligo-mannurarate capsule 900mg twice a day for 24 weeks
|
Sodium Oligo-mannurarate 600mg
n=76 Participants
Sodium oligo-mannurarate 600mg: sodium oligo-mannurarate capsule 600mg twice a day for 24 weeks
|
Placebo
n=83 Participants
Placebo: simulant of sodium oligo-mannurarate capsule
|
|---|---|---|---|
|
Change of Alzheimer's Disease Assessment Scale-cognitive Subscale(ADAS-cog)/12 After 24 Wks Treatment of Sodium Oligo-mannurarate Capsule
|
-2.58 units on a scale
Standard Error 0.62
|
-1.39 units on a scale
Standard Error 0.75
|
-1.45 units on a scale
Standard Error 0.77
|
SECONDARY outcome
Timeframe: 24 weeksClinician'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.
Outcome measures
| Measure |
Sodium Oligo-mannurarate 900mg
n=83 Participants
Sodium oligo-mannurarate 900mg: sodium oligo-mannurarate capsule 900mg twice a day for 24 weeks
|
Sodium Oligo-mannurarate 600mg
n=76 Participants
Sodium oligo-mannurarate 600mg: sodium oligo-mannurarate capsule 600mg twice a day for 24 weeks
|
Placebo
n=83 Participants
Placebo: simulant of sodium oligo-mannurarate capsule
|
|---|---|---|---|
|
Change of Clinician's Interview-Based Impression of Change Plus(CIBIC-plus) After 24 Wks Treatment of Sodium Oligo-mannurarate Capsule
Markedly improved
|
0 participants
|
2 participants
|
3 participants
|
|
Change of Clinician's Interview-Based Impression of Change Plus(CIBIC-plus) After 24 Wks Treatment of Sodium Oligo-mannurarate Capsule
Moderately improved
|
13 participants
|
9 participants
|
6 participants
|
|
Change of Clinician's Interview-Based Impression of Change Plus(CIBIC-plus) After 24 Wks Treatment of Sodium Oligo-mannurarate Capsule
Minimally improved
|
29 participants
|
18 participants
|
32 participants
|
|
Change of Clinician's Interview-Based Impression of Change Plus(CIBIC-plus) After 24 Wks Treatment of Sodium Oligo-mannurarate Capsule
No change
|
35 participants
|
23 participants
|
25 participants
|
|
Change of Clinician's Interview-Based Impression of Change Plus(CIBIC-plus) After 24 Wks Treatment of Sodium Oligo-mannurarate Capsule
Minimally worse
|
4 participants
|
21 participants
|
17 participants
|
|
Change of Clinician's Interview-Based Impression of Change Plus(CIBIC-plus) After 24 Wks Treatment of Sodium Oligo-mannurarate Capsule
Moderately worse
|
2 participants
|
3 participants
|
0 participants
|
|
Change of Clinician's Interview-Based Impression of Change Plus(CIBIC-plus) After 24 Wks Treatment of Sodium Oligo-mannurarate Capsule
Markedly worse
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Sodium Oligo-mannurarate 900mg
n=83 Participants
Sodium oligo-mannurarate 900mg: sodium oligo-mannurarate capsule 900mg twice a day for 24 weeks
|
Sodium Oligo-mannurarate 600mg
n=76 Participants
Sodium oligo-mannurarate 600mg: sodium oligo-mannurarate capsule 600mg twice a day for 24 weeks
|
Placebo
n=83 Participants
Placebo: simulant of sodium oligo-mannurarate capsule
|
|---|---|---|---|
|
Change of Alzheimer's Disease Cooperative Study/Activities of Daily(ADCS-ADL) After 24 Wks Treatment of Sodium Oligo-mannurarate Capsule
|
-0.49 units on a scale
Standard Error 0.91
|
-0.47 units on a scale
Standard Error 0.88
|
-1.06 units on a scale
Standard Error 0.85
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Sodium Oligo-mannurarate 900mg
n=83 Participants
Sodium oligo-mannurarate 900mg: sodium oligo-mannurarate capsule 900mg twice a day for 24 weeks
|
Sodium Oligo-mannurarate 600mg
n=76 Participants
Sodium oligo-mannurarate 600mg: sodium oligo-mannurarate capsule 600mg twice a day for 24 weeks
|
Placebo
n=83 Participants
Placebo: simulant of sodium oligo-mannurarate capsule
|
|---|---|---|---|
|
Change of Neuropsychiatric Inventory(NPI) After 24 Wks Treatment of Sodium Oligo-mannurarate Capsule
|
-1.11 units on a scale
Standard Error 1.22
|
0.24 units on a scale
Standard Error 0.83
|
-2.08 units on a scale
Standard Error 0.98
|
Adverse Events
Sodium Oligo-mannurarate 900mg
Sodium Oligo-mannurarate 600mg
Placebo
Serious adverse events
| Measure |
Sodium Oligo-mannurarate 900mg
n=86 participants at risk
Sodium oligo-mannurarate 900mg: sodium oligo-mannurarate capsule 900mg twice a day for 24 weeks
|
Sodium Oligo-mannurarate 600mg
n=84 participants at risk
Sodium oligo-mannurarate 600mg: sodium oligo-mannurarate capsule 600mg twice a day for 24 weeks
|
Placebo
n=85 participants at risk
Placebo: simulant of sodium oligo-mannurarate capsule
|
|---|---|---|---|
|
Psychiatric disorders
Behavioral and psychiatric symptoms
|
0.00%
0/86
|
1.2%
1/84 • Number of events 1
|
0.00%
0/85
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/86
|
0.00%
0/84
|
1.2%
1/85 • Number of events 1
|
|
Vascular disorders
Subdural hematoma
|
0.00%
0/86
|
1.2%
1/84 • Number of events 1
|
0.00%
0/85
|
|
Nervous system disorders
Stroke
|
0.00%
0/86
|
0.00%
0/84
|
1.2%
1/85 • Number of events 1
|
|
Cardiac disorders
Implantation of artificial heart pacemaker
|
0.00%
0/86
|
1.2%
1/84 • Number of events 1
|
0.00%
0/85
|
|
Nervous system disorders
Paralysis of oculomotor nerve
|
0.00%
0/86
|
0.00%
0/84
|
1.2%
1/85 • Number of events 1
|
|
Infections and infestations
Cellulitis
|
1.2%
1/86 • Number of events 1
|
0.00%
0/84
|
0.00%
0/85
|
|
Gastrointestinal disorders
Appendicitis
|
0.00%
0/86
|
0.00%
0/84
|
1.2%
1/85 • Number of events 1
|
|
Gastrointestinal disorders
Emptying disorder of intestine and stomach
|
0.00%
0/86
|
0.00%
0/84
|
1.2%
1/85 • Number of events 1
|
|
Cardiac disorders
Hypertension
|
1.2%
1/86 • Number of events 1
|
0.00%
0/84
|
0.00%
0/85
|
|
General disorders
Hernia
|
0.00%
0/86
|
1.2%
1/84 • Number of events 1
|
0.00%
0/85
|
|
General disorders
Chill
|
0.00%
0/86
|
0.00%
0/84
|
1.2%
1/85 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Compressive fracture of vertebra
|
0.00%
0/86
|
1.2%
1/84 • Number of events 1
|
0.00%
0/85
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer
|
0.00%
0/86
|
1.2%
1/84 • Number of events 1
|
0.00%
0/85
|
|
Nervous system disorders
Cerebral hemorrhage
|
1.2%
1/86 • Number of events 1
|
0.00%
0/84
|
0.00%
0/85
|
Other adverse events
| Measure |
Sodium Oligo-mannurarate 900mg
n=86 participants at risk
Sodium oligo-mannurarate 900mg: sodium oligo-mannurarate capsule 900mg twice a day for 24 weeks
|
Sodium Oligo-mannurarate 600mg
n=84 participants at risk
Sodium oligo-mannurarate 600mg: sodium oligo-mannurarate capsule 600mg twice a day for 24 weeks
|
Placebo
n=85 participants at risk
Placebo: simulant of sodium oligo-mannurarate capsule
|
|---|---|---|---|
|
Ear and labyrinth disorders
Ear and labyrinth
|
0.00%
0/86
|
1.2%
1/84 • Number of events 1
|
1.2%
1/85 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal
|
1.2%
1/86 • Number of events 1
|
0.00%
0/84
|
4.7%
4/85 • Number of events 4
|
|
Injury, poisoning and procedural complications
Injuries, toxicosis, complications due to surgery
|
0.00%
0/86
|
1.2%
1/84 • Number of events 1
|
0.00%
0/85
|
|
Musculoskeletal and connective tissue disorders
Muscular and connective tissue
|
0.00%
0/86
|
1.2%
1/84 • Number of events 1
|
0.00%
0/85
|
|
Nervous system disorders
CNS disorders
|
0.00%
0/86
|
1.2%
1/84 • Number of events 1
|
0.00%
0/85
|
|
Psychiatric disorders
Psychiatiric disorders
|
0.00%
0/86
|
6.0%
5/84 • Number of events 5
|
0.00%
0/85
|
|
Reproductive system and breast disorders
Reproductive system and mammary gland
|
1.2%
1/86 • Number of events 1
|
0.00%
0/84
|
0.00%
0/85
|
|
Respiratory, thoracic and mediastinal disorders
Respiratoty system, chest and mediastinum
|
0.00%
0/86
|
1.2%
1/84 • Number of events 1
|
0.00%
0/85
|
|
Skin and subcutaneous tissue disorders
Dermatologic
|
1.2%
1/86 • Number of events 1
|
2.4%
2/84 • Number of events 2
|
0.00%
0/85
|
Additional Information
Dr. Xianliang Xin
Shanghai Greenvalley Pharmaceutical Co., Ltd.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER