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  • A clinical study to evaluate the long-term safety of sodium oligomannate capsules (GV-971)

    （China Drug Trials.org identifier: CTR20210760）

    Primary Objective:

    To evaluate the long-term safety of GV-971 in clinical use

    Secondary Objectives:

    To evaluate the safety of GV-971 in patients with hepatic or renal insufficiency

    To evaluate the safety of GV-971 concomitantly used with common geriatric medications

    To evaluate the safety of GV-971 on common comorbidities in the elderly

    To evaluate the risk of GV-971 to the incidence of brainstem encephalitis in patients

    To evaluate the clinical efficacy of GV-971

    To evaluate the pharmacoeconomics of GV-971

    Study Design: 96-week, multi-center, single-arm, open-label study
    Number of Study Sites:approx. 60
    Investigational Product:Sodium Oligomannate Capsules provided for free, each capsule contains 150 mg of sodium oligomannate.
    Recommended Treatment Regimen: p.o., 450 mg (3 capsules) per dose, b.i.d., in morning and evening.
    Study Population: patients with cognitive impairment treated with GV-971
    Sample Size: 2500 pts
  • A clinical study to evaluate the long-term efficacy and safety of sodium oligomannate capsules (GV-971)

    (China Drug Trials.org identifier: CTR20212999)

    Study Objectives: To observe the long-term efficacy of GV-971 in clinical patients and observe the changes in blood biomarkers and gut microbiota after treatment, exploratively validate the mechanism of action of GV-971, and determine the incidence of known adverse reactions to GV-971 with long-term administration, observe the occurrence of new adverse reactions, analyze the relatedness, incidence, severity and risk factors of adverse reactions/events, to better guide the rational medication in clinical practice.
    Primary Objective:

    To evaluate the long-term efficacy of GV-971 in the treatment of patients with mild to moderate AD

    Secondary Objectives:

    To evaluate the long-term safety of GV-971 in clinical use

    To evaluate the pharmacoeconomics of GV-971

    Exploratory Objective:

    To evaluate the effect of GV-971 on the biomarkers of patients with AD

    Study Design: 96-week, multi-center, single-arm, open-label study
    Number of Study Sites:approx. 60
    Investigational Product:Sodium Oligomannate Capsules provided for free, each capsule contains 150 mg of sodium oligomannate. 150 mg
    Recommended Treatment Regimen:p.o., 450 mg (3 capsules) per dose, b.i.d., in morning and evening.
    Study Population:patients with mild to moderate AD
    Sample Size: 800 pts
  • A randomized, double-blind, placebo-controlled, parallel-group study for preliminary evaluation of Sodium Oligomannate Capsules in the treatment of patients with early- or mid-stage Parkinson's disease

    (GV investigator-initiated research)

    Protocol Title A study for preliminary evaluation of Sodium Oligomannate Capsules in the treatment of patients with early- or mid-stage Parkinson's disease
    Sponsor and Participating Unit Shanghai Tongji Hospital
    Principal Investigator Jin Lingjing
    Nature of the Study A randomized controlled study
    Study Objectives A study for preliminary evaluation of Sodium Oligomannate Capsules in the treatment of patients with early- or mid-stage Parkinson's disease
    Sample Size 150
    Study Population the treatment of patients with early- or mid-stage Parkinson's disease
    Method of the Study A randomized, double-blind, placebo-controlled, parallel-group study