Long-term Efficacy and Safety Study of GV-971

StatusActive, Not Recruiting
PhasePhase 4
Started

Record status This record was last updated November 15, 2024 (before its estimated January 2025 completion). Its status may not reflect the trial's current state.

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Record History

  1. Primary completion date: Jun 2024 to Jan 2025
    • Study sites: 42 to 40
    v4
  2. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 42 of 42 sites
    v3
  3. Study sites: 2 to 42v2
  4. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Sodium Oligomannate Capsules (GV-971) has been approved for treatment of mild to moderate Alzheimer's disease and improving the cognitive function of patients. This study plans to observe, in the clinical patients, the long-term efficacy and safety of GV-971, as well as the changes in blood and gut microbiota biomarkers after treatment, to validate the mechanism of action of GV-971, in order to better guide the rational use of drug in clinical practice.
Trial Details
NCT Number NCT05181475
Lead Sponsor Green Valley (Shanghai) Pharmaceuticals Co., Ltd.
Conditions
(from sponsor)		 Alzheimer Disease
Related terms Alzheimer Disease
Enrollment 800 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov