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

Alzheimer Disease Clinical Trial

Official title:

Phase II Study of Sodium Oligo-mannurarate Capsule on Mild to Moderate Alzheimer Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01453569
• Other study ID #: 9712011-1
• Status: Completed
• Phase: Phase 2
• First received: September 30, 2011
• Last updated: January 25, 2015
• Start date: October 2011
• Est. completion date: August 2013

Study information

• Verified date: January 2015
• Source: Shanghai Greenvalley Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 255
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognition Disorders
• Cognitive Impairment

Intervention

Drug:
• 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

Locations

Country	Name	City	State
China	The Central Hospital of Baotou	Baotou	Inner Mongolia
China	Beijing Hospital	Beijing	Beijing
China	Hunan Provincial People's Hospital	Changsha	Hunan
China	West China Hospital, West China School of Medicine Sichuan University	Chengdu	Sichuan
China	Chongqing Medical University Second Affiliated Hospital	Chongqing	Chongqing
China	The First Affliated Hospital of Third Military Medical University	Chongqing	Chongqing
China	The Third Affliated Hospital of Third Military Medical University	Chongqing	Chongqing
China	Guangzhou Brain Hospital	Guangzho	Guangdong
China	Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University	Guangzhou	Guangdong
China	Sir Run Run Shaw Hospital, Medical college of Zhejiang University	Hangzhou	Zhejiang
China	The First Affliated Hospital of Harbin Medical University	Harbin	Heilongjiang
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 Affliated Brain Hospital of Nanjing Medical University	Nanjing	Jiangsu
China	Shanghai Mental Health Center , Shanghai Jiao Tong University school of Medicine	Shanghai	Shanghai
China	The Ninth Hospital, Shanghai Jiao Tong University school of Medicine	Shanghai	Shanghai
China	The First Affliated Hospital of Chinese Medical University	Shenyang	Liaoning
China	Tianjin Medical University General Hospital	Tianjin	Tianjin
China	Wuhan General Hospital of Guangzhou Military of People's Military Army	Wuhan	Hubei
China	Zhongnan Hospital of Wuhan University	Wuhan	Hubei
China	Wuxi Mental Health Center	Wuxi	Jiangsu
China	Tangdu Hospital of The Forth Military Medical University of PLA	Xi'an	Shanxi
China	The 251 Hospital of People's Liberation Army	Zhangjiakou	Hebei

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Greenvalley Pharmaceutical Co., Ltd.	Shanghai Mental Health Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	24 weeks	No
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.	24 weeks	No
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.	24 weeks	No
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.	24 weeks	No