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Long-term Efficacy and Safety Study of GV-971

NCT05181475 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 800

Last updated 2024-11-15

No results posted yet for this study

Summary

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.

Conditions

  • Alzheimer Disease

Interventions

DRUG

Sodium Oligomannate Capsules (GV-971)

Sodium Oligomannate Capsules, each capsule contains 150 mg of sodium oligomannate. The recommended treatment is oral administration, 450 mg (3 capsules) per dose, bid, in morning and evening.

Sponsors & Collaborators

  • Green Valley (Shanghai) Pharmaceuticals Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-07
Primary Completion
2025-01-31
Completion
2025-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05181475 on ClinicalTrials.gov