Safety, Efficacy and Dose Titration of Sodium Oligo-mannurarate Capsule on Mild to Moderate Alzheimer's Disease
NCT ID: NCT01453569
Last Updated: 2015-01-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
255 participants
INTERVENTIONAL
2011-10-31
2013-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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
Interventions
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Sodium oligo-mannurarate 600mg
sodium oligo-mannurarate capsule 600mg twice a day for 24 weeks
Sodium oligo-mannurarate 900mg
sodium oligo-mannurarate capsule 900mg twice a day for 24 weeks
Placebo
simulant of sodium oligo-mannurarate capsule
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
50 Years
85 Years
ALL
No
Sponsors
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Shanghai Mental Health Center
OTHER
Shanghai Greenvalley Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Shifu Xiao, M.D.
Role: PRINCIPAL_INVESTIGATOR
Shanghai Mental Health Center
Locations
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Beijing Hospital
Beijing, Beijing Municipality, China
Chongqing Medical University Second Affiliated Hospital
Chongqing, Chongqing Municipality, China
The First Affliated Hospital of Third Military Medical University
Chongqing, Chongqing Municipality, China
The Third Affliated Hospital of Third Military Medical University
Chongqing, Chongqing Municipality, China
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China
Guangzhou Brain Hospital
Guangzho, Guangdong, China
The 251 Hospital of People's Liberation Army
Zhangjiakou, Hebei, China
The First Affliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Wuhan General Hospital of Guangzhou Military of People's Military Army
Wuhan, Hubei, China
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
Hunan Provincial People's Hospital
Changsha, Hunan, China
The Central Hospital of Baotou
Baotou, Inner Mongolia, China
The Affliated Brain Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Wuxi Mental Health Center
Wuxi, Jiangsu, China
The First Affliated Hospital of Chinese Medical University
Shenyang, Liaoning, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Shandong Provincial Hospital
Jinan, Shandong, China
The Second Hospital of Shandong University
Jinan, Shandong, China
The Ninth Hospital, Shanghai Jiao Tong University school of Medicine
Shanghai, Shanghai Municipality, China
Shanghai Mental Health Center , Shanghai Jiao Tong University school of Medicine
Shanghai, Shanghai Municipality, China
Tangdu Hospital of The Forth Military Medical University of PLA
Xi’an, Shanxi, China
West China Hospital, West China School of Medicine Sichuan University
Chengdu, Sichuan, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
Sir Run Run Shaw Hospital, Medical college of Zhejiang University
Hangzhou, Zhejiang, China
Countries
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References
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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.
Other Identifiers
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9712011-1
Identifier Type: -
Identifier Source: org_study_id
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