Long-term Efficacy and Safety Study of GV-971

A Clinical Study to Evaluate the Long-term Efficacy and Safety of Sodium Oligomannate Capsules (GV-971)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Alzheimer Disease
• Intervention / Treatment: Drug: Sodium Oligomannate Capsules (GV-971)

• Study Type: Interventional
• Enrollment (Actual): 800
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Xianliang Xin, Ph. D; Phone Number: 8821 +86 21 50504988; Email: xinxianliang@greenvalleypharma.com
• Study Contact Backup: Name: Kunxia Zhang, Master; Phone Number: 8832 +86 21 50504988; Email: zhangkunxia@greenvalleypharma.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Peking University Third Hospital
    • Beijing, Beijing, China
      • Peking University People's Hospital
    • Beijing, Beijing, China
      • Peking University Shougang Hospital
    • Beijing, Beijing, China
      • Beijing Chao-Yang Hospital
  • Chongqing
    • Chongqing, Chongqing, China
      • The First Affiliated Hospital of Chongqing Medical University
    • Chongqing, Chongqing, China
      • The Second Affiliated Hospital of Chongqing Medical University
  • Gansu
    • Lanzhou, Gansu, China
      • The First Hospital of Lanzhou University
    • Lanzhou, Gansu, China
      • Lanzhou University Second Hospital
  • Guangdong
    • Foshan, Guangdong, China
      • The First People's Hospital of Foshan
    • Guangzhou, Guangdong, China
      • Nanfang Hospital
    • Guangzhou, Guangdong, China
      • The Affiliated Brain Hospital of Guangzhou Medical University
    • Shenzhen, Guangdong, China
      • Shenzhen People's Hospital
    • Shenzhen, Guangdong, China
      • Peking University Shenzhen Hospital
  • Guizhou
    • Guiyang, Guizhou, China
      • The Affiliated Hospital Of Guizhou Medical University
  • Hebei
    • Baoding, Hebei, China
      • No.6 HeBei Provincial People's Hospital
  • Hubei
    • Wuhan, Hubei, China
      • Zhongnan Hospital of Wuhan University
    • Wuhan, Hubei, China
      • Union Hospital Tongji Medical College Huazhong University of Science and Technology
  • Hunan
    • Changsha, Hunan, China
      • The First Hospital of Changsha
  • Jiangsu
    • Nanjing, Jiangsu, China
      • The Second Affiliated Hospital of Nanjing Medical University
    • Wuxi, Jiangsu, China
      • Wuxi No.2 People's Hospital
    • Wuxi, Jiangsu, China
      • Wuxi Mental Health Center
    • Yangzhou, Jiangsu, China
      • Northern Jiangsu People's Hospital
  • Liaoning
    • Dalian, Liaoning, China
      • The Second Hospital of Dalian Medical University
    • Dalian, Liaoning, China
      • Affiliated Zhongshan Hospital of Dalian University
  • Shandong
    • Jinan, Shandong, China
      • The Second Hospital of Shandong University
    • Jinan, Shandong, China
      • Central Hospital Affiliated To Shandong First Medical University
    • Qingdao, Shandong, China
      • The Affiliated Hospital Of Qingdao University
  • Shanghai
    • Shanghai, Shanghai, China
      • Zhongshan Hospital
    • Shanghai, Shanghai, China
      • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
    • Shanghai, Shanghai, China
      • Shanghai East Hospital
    • Shanghai, Shanghai, China
      • Shanghai 6th People's Hospital
    • Shanghai, Shanghai, China
      • Shanghai Mental Health Center
    • Shanghai, Shanghai, China
      • Tongren Hospital Shanghai Jiao Tong University School Of Medicine
  • Shanxi
    • Xi'an, Shanxi, China
      • The First Affiliated Hospital of Xi'an Jiaotong University
  • Sichuan
    • Chengdu, Sichuan, China
      • Sichuan Academy of Medical Sciences·Sichuan Provincial People's Hospital
    • Chengdu, Sichuan, China
      • West China School of Medicine/West China Hospital of Sichuan University
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Sir Run Run Shaw Hospital Zhejiang University School of Medicine
    • Hangzhou, Zhejiang, China
      • The Second Affiliated Hospital Zhejiang University School of Medicine
    • Hangzhou, Zhejiang, China
      • The Affiliated Hospital of Hangzhou Normal University
    • Hangzhou, Zhejiang, China
      • Zhejiang Hospital
    • Hangzhou, Zhejiang, China
      • Tongde Hospital of Zhejiang Province
    • Wenzhou, Zhejiang, China
      • The First Affiliated Hospital of Wenzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Aged 50 to 85 years (inclusive), with no restriction on gender;
2. Patients who met criteria for "probable AD" by National Institute on Aging and Alzheimer's Association (NIA-AA) diagnostic criteria;
3. Patients with mild to moderate AD as characterized by Mini-Mental State Examination (MMSE) scores between 11 and 26, inclusive;
4. Patients who have received at least primary education and have capacity to complete the measurement of cognition and other tests as specified in the protocol;
5. Patients receiving GV-971 treatment prescribed by clinicians;
6. Sign the informed consent form.

Exclusion Criteria:

1. Patients who have received GV-971 treatment within 6 months prior to screening;
2. Patients who may be allergic to Sodium Oligomannate Capsules as judged by the investigator;
3. Female participants who are pregnant or lactating;
4. Patients who cannot cooperate to complete the follow-up inquiries;
5. Any other diseases or conditions that are inappropriate to participate in this clinical trial in the opinion of the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in the ADAS-cog/11 score	Change from baseline in Alzheimer's Disease Assessments Scale - cognitive (ADAS-cog/11) scale total score. The total score of ADAS-cog/11 is 0-70, with higher scores mean a worse outcome.	Baseline, 48 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in ADAS-Cog/11 score	Change from baseline in Alzheimer's Disease Assessments Scale - cognitive (ADAS-cog/11) scale total score. The total score of ADAS-cog/11 is 0-70, with higher scores mean a worse outcome.	Baseline, 96 weeks
Change from baseline in MMSE score	Change from baseline in Mini Mental State Examination (MMSE) score. The total score of MMSE is 0-30, with higher scores mean a better outcome.	Baseline, 48 weeks, 96 weeks
Change from baseline in ADCS-ADL score	Change from baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living; 23-item Scale (ACDS-ADL23) score. The total score of ADCS-ADL23 is 0-78, with higher scores mean a better outcome.	Baseline, 48 weeks, 96 weeks
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	The incidence of adverse events and adverse reactions of vital signs, laboratory tests, electrocardiogram, and early withdrawal from the study in patients treated with GV-971.	48 weeks, 96 weeks

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2021
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: December 2, 2021
• First Submitted That Met QC Criteria: January 3, 2022
• First Posted (Actual): January 6, 2022

Study Record Updates

• Last Update Posted (Actual): May 30, 2023
• Last Update Submitted That Met QC Criteria: May 25, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: GV-971-PMS-B

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No