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
1 other identifier
interventional
255
1 country
24
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 alzheimer-disease
Started Oct 2011
Shorter than P25 for phase_2 alzheimer-disease
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 30, 2011
CompletedStudy Start
First participant enrolled
October 1, 2011
CompletedFirst Posted
Study publicly available on registry
October 18, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedResults Posted
Study results publicly available
January 27, 2015
CompletedJanuary 27, 2015
January 1, 2015
1.8 years
September 30, 2011
November 13, 2014
January 25, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (3)
Change of Clinician's Interview-Based Impression of Change Plus(CIBIC-plus) After 24 Wks Treatment 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
24 weeks
Change of Neuropsychiatric Inventory(NPI) After 24 Wks Treatment of Sodium Oligo-mannurarate Capsule
24 weeks
Study Arms (3)
sodium oligo-mannurarate 900mg
EXPERIMENTALsodium oligo-mannurarate 600mg
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
sodium oligo-mannurarate capsule 600mg twice a day for 24 weeks
sodium oligo-mannurarate capsule 900mg twice a day for 24 weeks
Eligibility Criteria
You may qualify if:
- 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.
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
Beijing Hospital
Beijing, Beijing Municipality, 100005, China
Chongqing Medical University Second Affiliated Hospital
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
Related Publications (1)
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.
PMID: 32928279DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Xianliang Xin
- Organization
- Shanghai Greenvalley Pharmaceutical Co., Ltd.
Study Officials
- PRINCIPAL INVESTIGATOR
Shifu Xiao, M.D.
Shanghai Mental Health Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 30, 2011
First Posted
October 18, 2011
Study Start
October 1, 2011
Primary Completion
August 1, 2013
Study Completion
August 1, 2013
Last Updated
January 27, 2015
Results First Posted
January 27, 2015
Record last verified: 2015-01