Clinical trial NCT01453569: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer Disease
Cognitive Impairment
Lead sponsor: Shanghai Greenvalley Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Shanghai Mental Health Center
First posted: 2011-10-18
Enrollment: 255
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change of Alzheimer's Disease Assessment Scale-cognitive Subscale(ADAS-cog)/12 After 24 Wks Treatment of Sodium Oligo-mannurarate Capsule
timeFrame: 24 weeks
Secondary outcomes:
measure: Change of Clinician's Interview-Based Impression of Change Plus(CIBIC-plus) After 24 Wks Treatment of Sodium Oligo-mannurarate Capsule
timeFrame: 24 weeks
measure: Change of Alzheimer's Disease Cooperative Study/Activities of Daily(ADCS-ADL) After 24 Wks Treatment of Sodium Oligo-mannurarate Capsule
timeFrame: 24 weeks
measure: Change of Neuropsychiatric Inventory(NPI) After 24 Wks Treatment of Sodium Oligo-mannurarate Capsule
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Hospital
state: Beijing
city: Chongqing
country: China
facility: Chongqing Medical University Second Affiliated Hospital
state: Chongqing
city: Chongqing
country: China
facility: The First Affliated Hospital of Third Military Medical University
state: Chongqing
city: Chongqing
country: China
facility: The Third Affliated Hospital of Third Military Medical University
state: Chongqing
city: Guangzhou
country: China
facility: Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
state: Guangdong
city: Guangzho
country: China
facility: Guangzhou Brain Hospital
state: Guangdong
city: Zhangjiakou
country: China
facility: The 251 Hospital of People's Liberation Army
state: Hebei
city: Harbin
country: China
facility: The First Affliated Hospital of Harbin Medical University
state: Heilongjiang
city: Wuhan
country: China
facility: Wuhan General Hospital of Guangzhou Military of People's Military Army
state: Hubei
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
state: Hubei
city: Changsha
country: China
facility: Hunan Provincial People's Hospital
state: Hunan
city: Baotou
country: China
facility: The Central Hospital of Baotou
state: Inner Mongolia
city: Nanjing
country: China
facility: The Affliated Brain Hospital of Nanjing Medical University
state: Jiangsu
city: Wuxi
country: China
facility: Wuxi Mental Health Center
state: Jiangsu
city: Shenyang
country: China
facility: The First Affliated Hospital of Chinese Medical University
state: Liaoning
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Jinan
country: China
facility: Shandong Provincial Hospital
state: Shandong
city: Jinan
country: China
facility: The Second Hospital of Shandong University
state: Shandong
city: Shanghai
country: China
facility: The Ninth Hospital, Shanghai Jiao Tong University school of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Mental Health Center , Shanghai Jiao Tong University school of Medicine
state: Shanghai
city: Xi'an
country: China
facility: Tangdu Hospital of The Forth Military Medical University of PLA
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital, West China School of Medicine Sichuan University
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital, Medical college of Zhejiang University
state: Zhejiang
Study officials:
affiliation: Shanghai Mental Health Center
name: Shifu Xiao, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.