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| Name | Class |
|---|---|
| Shanghai Mental Health Center | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sodium oligo-mannurarate 900mg | Experimental |
| |
| sodium oligo-mannurarate 600mg | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium oligo-mannurarate 600mg | Drug | sodium oligo-mannurarate capsule 600mg twice a day for 24 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of Alzheimer's Disease Assessment Scale-cognitive Subscale(ADAS-cog)/12 After 24 Wks Treatment of Sodium Oligo-mannurarate Capsule | 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. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Clinician's Interview-Based Impression of Change Plus(CIBIC-plus) After 24 Wks Treatment of Sodium Oligo-mannurarate Capsule | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shifu Xiao, M.D. | Shanghai Mental Health Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Hospital | Beijing | Beijing Municipality | 100005 | China | ||
| Chongqing Medical University Second Affiliated Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32928279 | Derived | Wang T, Kuang W, Chen W, Xu W, Zhang L, Li Y, Li H, Peng Y, Chen Y, Wang B, Xiao J, Li H, Yan C, Du Y, Tang M, He Z, Chen H, Li W, Lin H, Shi S, Bi J, Zhou H, Cheng Y, Gao X, Guan Y, Huang Q, Chen K, Xin X, Ding J, Geng M, Xiao S. A phase II randomized trial of sodium oligomannate in Alzheimer's dementia. Alzheimers Res Ther. 2020 Sep 14;12(1):110. doi: 10.1186/s13195-020-00678-3. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sodium Oligo-mannurarate 900mg | Sodium oligo-mannurarate 900mg: sodium oligo-mannurarate capsule 900mg twice a day for 24 weeks |
| FG001 | Sodium Oligo-mannurarate 600mg | Sodium oligo-mannurarate 600mg: sodium oligo-mannurarate capsule 600mg twice a day for 24 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Sodium oligo-mannurarate 900mg | Drug | sodium oligo-mannurarate capsule 900mg twice a day for 24 weeks |
|
|
| Placebo | Drug | simulant of sodium oligo-mannurarate capsule |
|
| 24 weeks |
| Change of Alzheimer's Disease Cooperative Study/Activities of Daily(ADCS-ADL) After 24 Wks Treatment of Sodium Oligo-mannurarate Capsule | 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. | 24 weeks |
| Change of Neuropsychiatric Inventory(NPI) After 24 Wks Treatment of Sodium Oligo-mannurarate Capsule | 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. | 24 weeks |
| Chongqing |
| Chongqing Municipality |
| 400010 |
| China |
| The First Affliated Hospital of Third Military Medical University | Chongqing | Chongqing Municipality | 400038 | China |
| The Third Affliated Hospital of Third Military Medical University | Chongqing | Chongqing Municipality | 400042 | China |
| Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University | Guangzhou | Guangdong | 510120 | China |
| Guangzhou Brain Hospital | Guangzho | Guangdong | 510170 | China |
| The 251 Hospital of People's Liberation Army | Zhangjiakou | Hebei | 075000 | China |
| The First Affliated Hospital of Harbin Medical University | Harbin | Heilongjiang | 150001 | China |
| Wuhan General Hospital of Guangzhou Military of People's Military Army | Wuhan | Hubei | 430070 | China |
| Zhongnan Hospital of Wuhan University | Wuhan | Hubei | 430077 | China |
| Hunan Provincial People's Hospital | Changsha | Hunan | 410005 | China |
| The Central Hospital of Baotou | Baotou | Inner Mongolia | 014040 | China |
| The Affliated Brain Hospital of Nanjing Medical University | Nanjing | Jiangsu | 210029 | China |
| Wuxi Mental Health Center | Wuxi | Jiangsu | 214151 | China |
| The First Affliated Hospital of Chinese Medical University | Shenyang | Liaoning | 110001 | China |
| Qilu Hospital of Shandong University | Jinan | Shandong | 250012 | China |
| Shandong Provincial Hospital | Jinan | Shandong | 250021 | China |
| The Second Hospital of Shandong University | Jinan | Shandong | 250033 | China |
| The Ninth Hospital, Shanghai Jiao Tong University school of Medicine | Shanghai | Shanghai Municipality | 200011 | China |
| Shanghai Mental Health Center , Shanghai Jiao Tong University school of Medicine | Shanghai | Shanghai Municipality | 200030 | China |
| Tangdu Hospital of The Forth Military Medical University of PLA | Xi’an | Shanxi | 710038 | China |
| West China Hospital, West China School of Medicine Sichuan University | Chengdu | Sichuan | 610041 | China |
| Tianjin Medical University General Hospital | Tianjin | Tianjin Municipality | 300052 | China |
| Sir Run Run Shaw Hospital, Medical college of Zhejiang University | Hangzhou | Zhejiang | 310016 | China |
| FG002 | Placebo | Placebo: simulant of sodium oligo-mannurarate capsule |
| COMPLETED |
|
| NOT COMPLETED |
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | Sodium Oligo-mannurarate 900mg | Sodium oligo-mannurarate 900mg: sodium oligo-mannurarate capsule 900mg twice a day for 24 weeks |
| BG001 | Sodium Oligo-mannurarate 600mg | Sodium oligo-mannurarate 600mg: sodium oligo-mannurarate capsule 600mg twice a day for 24 weeks |
| BG002 | Placebo | Placebo: simulant of sodium oligo-mannurarate capsule |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change of Alzheimer's Disease Assessment Scale-cognitive Subscale(ADAS-cog)/12 After 24 Wks Treatment of Sodium Oligo-mannurarate Capsule | 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. | 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. | Posted | Mean | Standard Error | units on a scale | 24 weeks |
|
|
| |||||||||||||||||||||||||||||||
| Secondary | Change of Clinician's Interview-Based Impression of Change Plus(CIBIC-plus) After 24 Wks Treatment of Sodium Oligo-mannurarate Capsule | 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. | Posted | Number | participants | 24 weeks |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Change of Alzheimer's Disease Cooperative Study/Activities of Daily(ADCS-ADL) After 24 Wks Treatment of Sodium Oligo-mannurarate Capsule | 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. | 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. | Posted | Mean | Standard Error | units on a scale | 24 weeks |
| |||||||||||||||||||||||||||||||||
| Secondary | Change of Neuropsychiatric Inventory(NPI) After 24 Wks Treatment of Sodium Oligo-mannurarate Capsule | 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. | 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. | Posted | Mean | Standard Error | units on a scale | 24 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sodium Oligo-mannurarate 900mg | Sodium oligo-mannurarate 900mg: sodium oligo-mannurarate capsule 900mg twice a day for 24 weeks | 3 | 86 | 3 | 86 | ||
| EG001 | Sodium Oligo-mannurarate 600mg | Sodium oligo-mannurarate 600mg: sodium oligo-mannurarate capsule 600mg twice a day for 24 weeks | 6 | 84 | 12 | 84 | ||
| EG002 | Placebo | Placebo: simulant of sodium oligo-mannurarate capsule | 6 | 85 | 5 | 85 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Behavioral and psychiatric symptoms | Psychiatric disorders |
| |||
| Osteoarthritis | Musculoskeletal and connective tissue disorders |
| |||
| Subdural hematoma | Vascular disorders |
| |||
| Stroke | Nervous system disorders |
| |||
| Implantation of artificial heart pacemaker | Cardiac disorders |
| |||
| Paralysis of oculomotor nerve | Nervous system disorders |
| |||
| Cellulitis | Infections and infestations |
| |||
| Appendicitis | Gastrointestinal disorders |
| |||
| Emptying disorder of intestine and stomach | Gastrointestinal disorders |
| |||
| Hypertension | Cardiac disorders |
| |||
| Hernia | General disorders |
| |||
| Chill | General disorders |
| |||
| Compressive fracture of vertebra | Musculoskeletal and connective tissue disorders |
| |||
| Lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| |||
| Cerebral hemorrhage | Nervous system disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear and labyrinth | Ear and labyrinth disorders | Medication-related AE |
| ||
| Gastrointestinal | Gastrointestinal disorders | Medication-related AE |
| ||
| Injuries, toxicosis, complications due to surgery | Injury, poisoning and procedural complications | Medication-related AE |
| ||
| Muscular and connective tissue | Musculoskeletal and connective tissue disorders | Medication-related AE |
| ||
| CNS disorders | Nervous system disorders | Medication-related AE |
| ||
| Psychiatiric disorders | Psychiatric disorders | Medication-related AE |
| ||
| Reproductive system and mammary gland | Reproductive system and breast disorders | Medication-related AE |
| ||
| Respiratoty system, chest and mediastinum | Respiratory, thoracic and mediastinal disorders | Medication-related AE |
| ||
| Dermatologic | Skin and subcutaneous tissue disorders | Medication-related AE |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Xianliang Xin | Shanghai Greenvalley Pharmaceutical Co., Ltd. | 86 21-50504988 | 1370 | xinxianliang@hotmail.com |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |
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| Male |
|
| Participants |
|
|
Placebo: simulant of sodium oligo-mannurarate capsule
|
|
| OG002 |
| Placebo |
Placebo: simulant of sodium oligo-mannurarate capsule |
|
|