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

NCT02293915 | Completed Phase 3

• 1 other identifier: 971-III
• Study Type: interventional
• Target: 818
• Locations: 1 country
• Sites: 16

Brief Summary

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.

Conditions

Mild to Moderate Alzheimer Disease; Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• Improvement of Alzheimer's Disease Assessment Scale-cognitive subscale(ADAS-cog)/12 of sodium oligo-mannurarate capsule

  36 weeks

Secondary Outcomes (4)

• Improvement of Clinician's Interview-Based Impression of Change Plus(CIBIC-plus) of sodium oligo-mannurarate capsule

  36 weeks

• Improvement of Alzheimer's Disease Cooperative Study/Activities of Daily(ADCS-ADL) of sodium oligo-mannurarate capsule

  36 weeks

• Improvement of Neuropsychiatric Inventory(NPI) of sodium oligo-mannurarate capsule

  36 weeks

• Glucose metabolism of bilateral temporoparietal cortex

  36 weeks

Study Arms (2)

sodium oligo-mannurarate 900mg

EXPERIMENTAL

Drug: Sodium oligo-mannurarate 900mg

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Sodium oligo-mannurarate 900mg DRUG

sodium oligo-mannurarate capsule 900mg twice a day for 24 weeks

Also known as: GV-971

sodium oligo-mannurarate 900mg

Placebo DRUG

simulant of sodium oligo-mannurarate capsule

Placebo

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 50-85 years (inclusive), no gender limitation;
• 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;
• Subjects have received education in primary school and above and are able to complete protocol specified cognitive ability test and other tests;
• Impaired memory for at least 12 months, with a tendency of progressive aggravation;
• 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);
• Patients with mild to moderate disease, i.e. 11 ≤total MMSE score ≤26 (for subjects with primary school education, 11 ≤total MMSE score ≤22);
• Total Hachinski Ischemia Scale (HIS) score ≤4 ;
• Total Hamilton Depression Scale/17-item (HAMD) score ≤10;
• In screening, cranial MRI plain scan and oblique coronal hippocampus scan must be performed, 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);
• Neurological examination shows no significant sign;
• 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.
• 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.

You may not qualify if:

• Participate in another clinical trial within 30 days prior to initiation of this study;
• Pregnant or nursing women;
• 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;
• Previous nervous system disorders (including stroke, optic neuromyelitis, Parkinson's disease, epilepsy);
• 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, platelet, hemoglobin below the lower limit of normal, blood glucose \>1.5 times of upper limit of normal;
• In screening, systolic blood pressure ≥160 mmHg or \<90 mmHg, or diastolic blood pressure ≥100 mmHg or \<60 mmHg;
• 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 \<55 bpm;
• Visual or hearing disorder, preventing completion of neuropsychological test and scale evaluation;
• In screening, MRI examination shows significant focal lesions, 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; Fazekas scale for white matter lesions at ≥ grade 3;
• Alcohol abuse or drug abuse;
• Patients with psychosis, including severe depression;
• Patients who are using drugs for Alzheimer's disease which can not be stopped;
• Use of heparin, Propylene Glycol Mannurate Sulfate or Alginric Sodium Diester within 3 weeks prior to screening;
• Inability to take trial drugs according to prescription, previous non-compliance with prescription or possibility of non-compliance with study treatment in the trial;
• Investigators consider subjects can not complete this study;

Sponsors & Collaborators

• Shanghai Greenvalley Pharmaceutical Co., Ltd.: lead

Study Sites (16)

Beijing

Beijing, Beijing Municipality, 100005, China

Location

Chongqing

Chongqing, Chongqing Municipality, 400010, China

Location

Fujian

Fuzhou, Fujian, China

Location

Guangzhou

Guangzhou, Guangdong, China

Location

Wuhan

Wuhan, Hubei, 430077, China

Location

Changsha

Changsha, Hunan, China

Location

Nanjing

Nanjing, Jiangsu, China

Location

Suzhou

Suzhou, Jiangsu, China

Location

Yangzhou

Yangzhou, Jiangsu, China

Location

Jinan

Jinan, Shandong, 250021, China

Location

Shanghai

Shanghai, Shanghai Municipality, 200030, China

Location

Xi'an

Xi’an, Shanxi, China

Location

Sichuan

Chengdu, Sichuan, 610041, China

Location

Tianjin

Tianjin, Tianjin Municipality, 300052, China

Location

Hangzhou

Hangzhou, Zhejiang, 310016, China

Location

Wenzhou

Wenzhou, Zhejiang, China

Location

Related Publications (1)

• Ferrari C, Sorbi S. The complexity of Alzheimer's disease: an evolving puzzle. Physiol Rev. 2021 Jul 1;101(3):1047-1081. doi: 10.1152/physrev.00015.2020. Epub 2021 Jan 21.

  PMID: 33475022 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

GV-971

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 3
• 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: November 13, 2014
• First Posted: November 19, 2014
• Study Start: April 1, 2014
• Primary Completion: June 29, 2018
• Study Completion: September 28, 2018
• Last Updated: October 10, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (16)