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An Efficacy and Safety Study of Sodium Oligo-mannurarate (GV-971) Capsule for the Treatment of Alzheimer's Disease

This study is currently recruiting participants.
See Contacts and Locations
Verified August 2016 by Shanghai Greenvalley Pharmaceutical Co., Ltd.
Sponsor:
Information provided by (Responsible Party):
Shanghai Greenvalley Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT02293915
First received: November 13, 2014
Last updated: August 8, 2016
Last verified: August 2016
  Purpose
The primary purpose of this study is to determine the efficacy and safety of Sodium Oligo-mannurarate (GV-971) in 36-week treatment of mild to moderate Alzheimer's disease.

Condition Intervention Phase
Mild to Moderate Alzheimer Disease Cognitive Impairment Drug: Sodium oligo-mannurarate 900mg Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Phase III Study of Sodium Oligo-mannurarate (GV-971) Capsule on Mild to Moderate Alzheimer Disease

Resource links provided by NLM:


Further study details as provided by Shanghai Greenvalley Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • Improvement of Alzheimer's Disease Assessment Scale-cognitive subscale(ADAS-cog)/12 of sodium oligo-mannurarate capsule [ Time Frame: 24 weeks, 36 weeks ]

Secondary Outcome Measures:
  • Improvement of Clinician's Interview-Based Impression of Change Plus(CIBIC-plus) of sodium oligo-mannurarate capsule [ Time Frame: 24 weeks, 36 weeks ]
  • Improvement of Alzheimer's Disease Cooperative Study/Activities of Daily(ADCS-ADL) of sodium oligo-mannurarate capsule [ Time Frame: 24 weeks, 36 weeks ]
  • Improvement of Neuropsychiatric Inventory(NPI) of sodium oligo-mannurarate capsule [ Time Frame: 24 weeks, 36 weeks ]
  • Glucose metabolism of bilateral temporoparietal cortex [ Time Frame: 0 week, 36 weeks ]
    Obtained by Positron Emission Tomography in two sites.


Estimated Enrollment: 788
Study Start Date: April 2014
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: sodium oligo-mannurarate 900mg Drug: Sodium oligo-mannurarate 900mg
sodium oligo-mannurarate capsule 900mg twice a day for 24 weeks
Other Name: GV-971
Placebo Comparator: Placebo Drug: Placebo
simulant of sodium oligo-mannurarate capsule

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Aged 50-85 years (inclusive), no gender limitation;
  2. Female subjects should be postmenopausal women (menopause >24 weeks), surgically sterilized women or women of child bearing age who agree to take effective contraceptive measures during the trial. Women of child bearing age and women less than 24 weeks from menopause must undergo urine pregnancy test in screening period and result must be negative;
  3. Subjects have received education in primary school and above and are able to complete protocol specified cognitive ability test and other tests;
  4. Impaired memory for at least 12 months, with a tendency of progressive aggravation;
  5. Meet diagnostic criteria of probable AD according to National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) (1984);
  6. Patients with mild to moderate disease, i.e. 11 ≤total MMSE score ≤26 (for subjects with primary school education, 11 ≤total MMSE score ≤22);
  7. Total Hachinski Ischemia Scale (HIS) score ≤4 ;
  8. Total Hamilton Depression Scale/17-item (HAMD) score ≤10;
  9. In screening, cranial MRI plain scan and oblique coronal hippocampus scan must be performed, for subject at ≤ 70 of age, Fazekas scale for white matter lesions should be at ≤grade 1 (mild white matter lesion), for subject at > 70 of age, the scale should be ≤ grade 2, lacunar infarction lesions with a diameter larger than 2 cm ≤2, without lacunar infarction lesion in vital sites, such as thalamus, hippocampus, entorhinal cortex, paraolfactory cortex, cortex and other subcortical gray matter nuclei; MRI shows highest possibility of Alzheimer's disease (medial temporal lobe atrophy visual rating scale MTA grade ≥2);
  10. Neurological examination shows no significant sign;
  11. Subjects should have stable, reliable caregivers, or at least have frequent contact with caregivers (at least 4 days every week, at least 2 h every day), and caregivers will help patients in participation in this study. Caregivers must accompany subjects to participate in study visits and have sufficient interaction and communication with subjects, so as to provide valuable information on NPI, ADCS-ADL, CIBIC-plus scales.
  12. Before implementation of any protocol related procedure or examination, subjects must sign the written informed consent form. If subjects can not sign due to limited cognition, legal guardians should sign on behalf of subjects and meanwhile, legal guardians should also sign the informed consent form.

Exclusion Criteria:

  1. Participate in another clinical trial within 30 days prior to initiation of this study;
  2. Pregnant or nursing women;
  3. Dementia due to other causes: vascular dementia, central nervous system infection (e.g. AIDS, syphilis), Creutzfeldt-Jakob disease, Huntington's chorea, Parkinson's disease, dementia with Lewy bodies, traumatic dementia, other physical and chemical factors (e.g. drug poisoning, alcoholism, carbon monoxide poisoning), significant physical illness (e.g. hepatic encephalopathy, pulmonary encephalopathy), intracranial occupying lesion (e.g. subdural hematoma, brain tumor), endocrine disorders (e.g. thyroid disease, parathyroid disease) and dementia caused by vitamin or other factors;
  4. Previous nervous system disorders (including stroke, optic neuromyelitis, Parkinson's disease, epilepsy);
  5. Abnormal laboratory values: liver function (ALT, AST) > 1.5 times of upper limit of normal, Cr > 1.5 times of upper limit of normal, white blood cell count <4.0×109 or platelet <100×109, hemoglobin <100 g/L, blood glucose >1.5 times of upper limit of normal;
  6. In screening, systolic blood pressure ≥160 mmHg or <90 mmHg, or diastolic blood pressure ≥100 mmHg or <60 mmHg;
  7. Unstable or severe cardiac, pulmonary, hepatic, renal or hematopoietic disease (including unstable angina, uncontrolled asthma, active gastric bleeding and cancer), after 10 min rest, resting heart rate <60 bpm;
  8. Visual or hearing disorder, preventing completion of neuropsychological test and scale evaluation;
  9. In screening, MRI examination shows significant focal lesions,for subject at ≤ 70 of age, Fazekas scale for white matter lesions at >grade 1, for subject at > 70 of age, the scale > grade 2, more than 2 lacunar infarction lesions with a diameter >2 cm, lacunar infarction lesions in vital sites, such as thalamus, hippocampus, entorhinal cortex, paraolfactory cortex, cortex and other subcortical gray matter nuclei;
  10. Alcohol abuse or drug abuse;
  11. Patients with psychosis, including severe depression;
  12. Patients who are using drugs for Alzheimer's disease which can not be stopped;
  13. Use of heparin, Propylene Glycol Mannurate Sulfate or Alginric Sodium Diester within 3 weeks prior to screening;
  14. Inability to take trial drugs according to prescription, previous non-compliance with prescription or possibility of non-compliance with study treatment in the trial;
  15. Investigators consider subjects can not complete this study;
  16. Subjects in the phase II trial of the study drug;
  17. Subjects are investigators participating in this study or their direct relatives, staff of Quintiles (Shanghai) or Shanghai Greenvalley Pharmaceutical Co., Ltd. or their direct relatives.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02293915

Contacts
Contact: Xianliang Xin, Coordinator 86-21-50504988 ext 1370 xinxianliang@green-valley.com

Locations
China, Beijing
Beijing Recruiting
Beijing, Beijing, China, 100005
Contact: Xianliang Xin, Coordinator    86-21-50504988 ext 1370    xinxianliang@green-valley.com   
China, Chongqing
Chongqing Recruiting
Chongqing, Chongqing, China, 400010
Contact: Xianliang Xin, MD    8623-50504988 ext 1370    xinxianliang@green-valley.com   
China, Hubei
Wuhan Recruiting
Wuhan, Hubei, China, 430077
Contact: Xianliang Xin, Coordinator    86-21-50504988 ext 1370    xinxianliang@green-valley.com   
China, Shandong
Jinan Recruiting
Jinan, Shandong, China, 250021
Contact: Xianliang Xin, Coordinator    86-21-50504988 ext 1370    xinxianliang@green-valley.com   
China, Shanghai
Shanghai Recruiting
Shanghai, Shanghai, China, 200030
Contact: Xianliang Xin, Coordinator    8621-50504988 ext 1370    xinxianliang@green-valley.com   
China, Sichuan
Sichuan Recruiting
Chengdu, Sichuan, China, 610041
Contact: Xianliang Xin, MD    8621-50504988 ext 1370    xinxianliang@green-valley.com   
China, Tianjin
Tianjin Recruiting
Tianjin, Tianjin, China, 300052
Contact: Xianliang Xin, MD    8621-50504988 ext 1370    xinxianliang@green-valley.com   
China, Zhejiang
Hangzhou Recruiting
Hangzhou, Zhejiang, China, 310016
Contact: Xianliang Xin, Coordinator    86-21-50504988 ext 1370    xinxianliang@green-valley.com   
Sponsors and Collaborators
Shanghai Greenvalley Pharmaceutical Co., Ltd.
  More Information

Responsible Party: Shanghai Greenvalley Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT02293915     History of Changes
Other Study ID Numbers: 971-III
Study First Received: November 13, 2014
Last Updated: August 8, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Alzheimer Disease
Cognition Disorders
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 18, 2017