A Clinical Study to Evaluate the Long-Term Safety Sodium Oligomannate Capsules (GV-971)

Phase 4

Active, not recruiting

• Conditions: Alzheimer Disease
• Interventions: Drug: Sodium Oligomannate Capsules

• Registration Number: NCT05058040
• Lead Sponsor: Green Valley (Shanghai) Pharmaceuticals Co., Ltd.

Brief Summary

A clinical study to evaluate the long-term safety of Sodium Oligomannate Capsules (GV-971)

Detailed Description

Sodium oligomannate (Code: GV-971), a marine-derived oligosaccharide after extraction, separation and degradation from algae, can play a role in the treatment of Alzheimer's disease by reconditioning the dysbiosis of gut microbiota, preventing peripheral immune cells from invading the brain, inhibiting the inflammatory response in the brain, and targeting protein folding errors in the brain tissue. Phase I clinical study shows GV-971 was safe and tolerated in healthy adult volunteers when administered continuously at 1200 mg/dose or 1500 mg/day (750 mg/dose, bid) for 5 days. Phase II and III clinical studies show that the treatment of GV-971 at 900 mg/day dosage for 36 weeks can significantly improve the cognitive function of patients with mild to moderate Alzheimer's disease (AD) and was safe and well-tolerated.

Sodium Oligomannate Capsules obtained approval from China's National Medical Products Administration (NMPA) on November 2, 2019, with approval letter number of 2019S00571. This product is a chemical drug with a registration classification of 1.2. It is approved for the clinical indication of mild to moderate Alzheimer's disease and the function of improving the cognitive function of patients. The clinical dosage and administration is 3 capsules (450 mg)/time, bid, po.

Due to the limited number of subjects and observation period of medication in completed GV-971 clinical studies, and the screening of patients with the strict inclusion and exclusion criteria, the adverse reactions and long-term safety of GV-971 cannot be comprehensively observed and recorded. Therefore, according to the requirements of the NMPA for the marketing of new drugs, this study is intended to further carry out a post-marketing investigation on expanded population using a design of a 96-week intensive monitoring clinical trial to determine the incidence of known adverse reactions of GV-971 under long-term administration, observe the occurrence of new adverse reactions, analyze the correlation, incidence, severity, and risk factors of adverse reactions/events, and better guide the rational use of drugs in clinical practice.

Study Timeline

• Study First Submitted: 2021-05-16
• Study Start: 2021-06-02
• Study First Submitted QC: 2021-09-16
• Study First Posted: 2021-09-27
• Status Verified: 2024-11
• Primary Completion: 2025-01
• Last Update Submitted: 2025-01-22
• Last Update Posted: 2025-01-24
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 2500

Inclusion Criteria

• Subjects eligible for this study must meet all of the following criteria:

  1. ≥18 years of age;
  2. Signed informed consent form;
  3. Patients receiving GV-971 treatment prescribed by clinicians;

Exclusion Criteria

• A subject may be excluded from participation in the study if any of the following apply:

  1. Patients who may be allergic to Sodium Oligomannate Capsules as judged by the investigator;
  2. Female participants who are pregnant or lactating;
  3. Patients who cannot cooperate to complete the follow-up inquiries;
  4. Any other diseases or conditions that are inappropriate to participate in this clinical trial in the opinion of the investigator.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GV-971	Sodium Oligomannate Capsules	The recommended dose regimen for subjects: GV-971 450 mg (3 capsules) per dose, bid, po. in morning and evening

Primary Outcome Measures

Name	Time	Method
Long-term safety of GV-971 in clinical practice during 48 weeks	Week 48	The incidence of adverse reactions and AE/SAE in patients treated with GV-971 during the 48-week monitoring period
Long-term safety of GV-971 in clinical practice during 96 weeks	Week 96	The incidence of adverse reactions and AE/SAE in patients treated with GV-971 during the 96-week monitoring period

Secondary Outcome Measures

Name	Time	Method
Safety Endpoints: Vital signs, laboratory tests , electrocardiogram, and early withdrawal from the study during 96 weeks	96-week	The incidence of adverse events and adverse reactions in patients with liver insufficiency and renal insufficiency receiving GV-971 during 96 weeks
Safety Endpoints: Vital signs, laboratory tests , electrocardiogram, and early withdrawal from the study during 48 weeks	48-week	The incidence of adverse events and adverse reactions in patients with liver insufficiency and renal insufficiency receiving GV-971 during 48 weeks

Trial Locations

Locations (63)

Anhui Mental Health Center; 🇨🇳 Hefei, Anhui, China

The First Affiliated Hospital of USTC(Anhui Provincial Hospital); 🇨🇳 Hefei, Anhui, China

Beijing Bo'ai Hospital; 🇨🇳 Beijing, Beijing, China

Beijing Geriatric Hospital; 🇨🇳 Beijing, Beijing, China

Beijing Luhe Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

Dongfang Hospital Beijing University of Chinese Medicine; 🇨🇳 Beijing, Beijing, China

Sanbo Brain Hospital Capital Medical University; 🇨🇳 Beijing, Beijing, China

Chongqing 11th People's Hospital (Chongqing Special Care Hospital); 🇨🇳 Chongqing, Chongqing, China

Xiamen Xianyue Hospital; 🇨🇳 Xianmen, Fujian, China

Dongguan People's Hospital; 🇨🇳 Dongguan, Guangdong, China

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