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

Primary Purpose

Alzheimer Disease, Cognitive Impairment

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Sodium oligo-mannurarate 600mg
Sodium oligo-mannurarate 900mg
Placebo
Sponsored by
Shanghai Greenvalley Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.
  • 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:

  • 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.

Sites / Locations

  • Beijing Hospital
  • Chongqing Medical University Second Affiliated Hospital
  • The First Affliated Hospital of Third Military Medical University
  • The Third Affliated Hospital of Third Military Medical University
  • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
  • Guangzhou Brain Hospital
  • The 251 Hospital of People's Liberation Army
  • The First Affliated Hospital of Harbin Medical University
  • Wuhan General Hospital of Guangzhou Military of People's Military Army
  • Zhongnan Hospital of Wuhan University
  • Hunan Provincial People's Hospital
  • The Central Hospital of Baotou
  • The Affliated Brain Hospital of Nanjing Medical University
  • Wuxi Mental Health Center
  • The First Affliated Hospital of Chinese Medical University
  • Qilu Hospital of Shandong University
  • Shandong Provincial Hospital
  • The Second Hospital of Shandong University
  • The Ninth Hospital, Shanghai Jiao Tong University school of Medicine
  • Shanghai Mental Health Center , Shanghai Jiao Tong University school of Medicine
  • Tangdu Hospital of The Forth Military Medical University of PLA
  • West China Hospital, West China School of Medicine Sichuan University
  • Tianjin Medical University General Hospital
  • Sir Run Run Shaw Hospital, Medical college of Zhejiang University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

sodium oligo-mannurarate 900mg

sodium oligo-mannurarate 600mg

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
September 30, 2011
Last Updated
January 25, 2015
Sponsor
Shanghai Greenvalley Pharmaceutical Co., Ltd.
Collaborators
Shanghai Mental Health Center
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1. Study Identification

Unique Protocol Identification Number
NCT01453569
Brief Title
Safety, Efficacy and Dose Titration of Sodium Oligo-mannurarate Capsule on Mild to Moderate Alzheimer's Disease
Official Title
Phase II Study of Sodium Oligo-mannurarate Capsule on Mild to Moderate Alzheimer Disease
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Greenvalley Pharmaceutical Co., Ltd.
Collaborators
Shanghai Mental Health Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Cognitive Impairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
255 (Actual)

8. Arms, Groups, and Interventions

Arm Title
sodium oligo-mannurarate 900mg
Arm Type
Experimental
Arm Title
sodium oligo-mannurarate 600mg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Sodium oligo-mannurarate 600mg
Other Intervention Name(s)
Sodium oligo-mannurarate low dose
Intervention Description
sodium oligo-mannurarate capsule 600mg twice a day for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Sodium oligo-mannurarate 900mg
Other Intervention Name(s)
Sodium oligo-mannurarate high dose
Intervention Description
sodium oligo-mannurarate capsule 900mg twice a day for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
simulant of sodium oligo-mannurarate capsule
Primary Outcome Measure Information:
Title
Change of Alzheimer's Disease Assessment Scale-cognitive Subscale(ADAS-cog)/12 After 24 Wks Treatment of Sodium Oligo-mannurarate Capsule
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
Secondary Outcome Measure Information:
Title
Change of Clinician's Interview-Based Impression of Change Plus(CIBIC-plus) After 24 Wks Treatment of Sodium Oligo-mannurarate Capsule
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
Title
Change of Alzheimer's Disease Cooperative Study/Activities of Daily(ADCS-ADL) After 24 Wks Treatment of Sodium Oligo-mannurarate Capsule
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
Title
Change of Neuropsychiatric Inventory(NPI) After 24 Wks Treatment of Sodium Oligo-mannurarate Capsule
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shifu Xiao, M.D.
Organizational Affiliation
Shanghai Mental Health Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100005
Country
China
Facility Name
Chongqing Medical University Second Affiliated Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400010
Country
China
Facility Name
The First Affliated Hospital of Third Military Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400038
Country
China
Facility Name
The Third Affliated Hospital of Third Military Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400042
Country
China
Facility Name
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Facility Name
Guangzhou Brain Hospital
City
Guangzho
State/Province
Guangdong
ZIP/Postal Code
510170
Country
China
Facility Name
The 251 Hospital of People's Liberation Army
City
Zhangjiakou
State/Province
Hebei
ZIP/Postal Code
075000
Country
China
Facility Name
The First Affliated Hospital of Harbin Medical University
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150001
Country
China
Facility Name
Wuhan General Hospital of Guangzhou Military of People's Military Army
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430070
Country
China
Facility Name
Zhongnan Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430077
Country
China
Facility Name
Hunan Provincial People's Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410005
Country
China
Facility Name
The Central Hospital of Baotou
City
Baotou
State/Province
Inner Mongolia
ZIP/Postal Code
014040
Country
China
Facility Name
The Affliated Brain Hospital of Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Facility Name
Wuxi Mental Health Center
City
Wuxi
State/Province
Jiangsu
ZIP/Postal Code
214151
Country
China
Facility Name
The First Affliated Hospital of Chinese Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110001
Country
China
Facility Name
Qilu Hospital of Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
Facility Name
Shandong Provincial Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250021
Country
China
Facility Name
The Second Hospital of Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250033
Country
China
Facility Name
The Ninth Hospital, Shanghai Jiao Tong University school of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200011
Country
China
Facility Name
Shanghai Mental Health Center , Shanghai Jiao Tong University school of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Facility Name
Tangdu Hospital of The Forth Military Medical University of PLA
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710038
Country
China
Facility Name
West China Hospital, West China School of Medicine Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300052
Country
China
Facility Name
Sir Run Run Shaw Hospital, Medical college of Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310016
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
32928279
Citation
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.
Results Reference
derived

Learn more about this trial

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

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