An Efficacy and Safety Study of Sodium Oligomannate (GV-971) for the Treatment of Alzheimer's Disease

November 8, 2023 updated by: Green Valley (Shanghai) Pharmaceuticals Co., Ltd.

A 36-week, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Clinical Trial to Evaluate the Efficacy and Safety of Sodium Oligomannate (GV-971) in Treatment of Mild to Moderate Alzheimer's Disease

The primary purpose of this study is to confirm the clinical efficacy and mechanism of action of GV-971, and identify incidence of known adverse reactions in long-term use and observe new adverse reactions, providing more guidance for clinical use.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1312

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Anhui
      • Huainan, Anhui, China
        • Recruiting
        • Huainan First People's Hospital
        • Contact:
          • Mei Zhang
        • Contact:
          • Chuanqing Yu
    • Beijing
      • Beijing, Beijing, China
        • Not yet recruiting
        • Beijing Hospital
        • Contact:
          • Haibo Chen
      • Beijing, Beijing, China
        • Recruiting
        • Xuanwu Hospital, Capital Medical University
        • Contact:
          • Jianping Jia
      • Beijing, Beijing, China
        • Not yet recruiting
        • Beijing AnZhen Hospital, Capital Medical University
        • Contact:
          • Guangzhi Liu
      • Beijing, Beijing, China
        • Not yet recruiting
        • Beijing Anding Hospital, Capital Medical University
        • Contact:
          • Qinge Zhang
      • Beijing, Beijing, China
        • Not yet recruiting
        • Peking University Shougang Hospital
        • Contact:
          • Shudong Qiao
      • Beijing, Beijing, China
        • Not yet recruiting
        • Beijing Tongren Hospital, Capital Medical University
        • Contact:
          • Jiawei Wang
      • Beijing, Beijing, China
        • Not yet recruiting
        • The first medical center, Chinese PLA General Hospital
        • Contact:
          • Shengyuan Yu
    • Fujian
      • Xiamen, Fujian, China
        • Not yet recruiting
        • The First Affiliated Hopsital of Xiamen University
        • Contact:
          • Kunmu Zheng
    • Guangdong
      • Guangzhou, Guangdong, China
        • Not yet recruiting
        • The Affiliated Brain Hospital of Guangzhou Medical University
        • Contact:
          • Yuping Ning
      • Guangzhou, Guangdong, China
        • Not yet recruiting
        • Guangdong Provincial Hospital of Chinese Medicine
        • Contact:
          • Yefeng Cai
      • Guangzhou, Guangdong, China
        • Not yet recruiting
        • The First Affiliated Hopsital of Guangzhou Medical University
        • Contact:
          • Qin Liu
      • Guangzhou, Guangdong, China
        • Recruiting
        • The Second Affiliated Hopsital of Guangzhou Medical University
        • Contact:
          • Jun Liu
      • Shenzhen, Guangdong, China
        • Not yet recruiting
        • Peking University Shenzhen Hospital
        • Contact:
          • Xuhui Chen
    • Guangxi
      • Nanning, Guangxi, China
        • Recruiting
        • The First People's Hospital of Nanning
        • Contact:
          • Xianfeng Li
    • Hebei
      • Shijiazhuang, Hebei, China
        • Recruiting
        • The First Hospital of Hebei Medical University
        • Contact:
          • Qinying Ma
      • Shijiazhuang, Hebei, China
        • Recruiting
        • Shijiazhuang People's Hospital
        • Contact:
          • Huiying Zhao
      • Shijiazhuang, Hebei, China
        • Not yet recruiting
        • The Second Hopsital of Hebei Medical University
        • Contact:
          • Yaling Liu
      • Tangshan, Hebei, China
        • Recruiting
        • Tangshan Workers' Hospital
        • Contact:
          • Yongqiu Li
    • Henan
      • Nanyang, Henan, China
        • Not yet recruiting
        • The First Affiliated Hopsital of Nanyang Medical College
        • Contact:
          • Qian Deng
      • Zhengzhou, Henan, China
        • Not yet recruiting
        • Henan Provincial People's Hospital
        • Contact:
          • Jiewen Zhang
    • Hubei
      • Wuhan, Hubei, China
        • Not yet recruiting
        • Wuhan Hospital Of Traditional Chinese and Western Medicine (Wuhan No.1 Hospital)
        • Contact:
          • Wei Shao
    • Hunan
      • Changsha, Hunan, China
        • Not yet recruiting
        • Xiangya Hospital Central South University
        • Contact:
          • Lu Shen
      • Changsha, Hunan, China
        • Not yet recruiting
        • The third xiangya hospital of Central South University
        • Contact:
          • Deren Hou
      • Chenzhou, Hunan, China
        • Not yet recruiting
        • Chenzhou First People's Hospital
        • Contact:
          • Xiaoxi Yao
      • Yueyang, Hunan, China
        • Not yet recruiting
        • Yueyang Central Hospital
        • Contact:
          • Xiang Huang
    • Jiangsu
      • Huai'an, Jiangsu, China
        • Not yet recruiting
        • Huai'an Second People's Hospital
        • Contact:
          • Liandong Zhao
      • Nanjing, Jiangsu, China
        • Not yet recruiting
        • Nanjing Brain Hospital
        • Contact:
          • Rong Lu
      • Nantong, Jiangsu, China
        • Not yet recruiting
        • Affiliated Hospital of Nantong University
        • Contact:
          • Maohong Cao
      • Xuzhou, Jiangsu, China
        • Recruiting
        • The Affiliated Hospital of Xuzhou Medical University
        • Contact:
          • Guiyun Cui
      • Yangzhou, Jiangsu, China
        • Not yet recruiting
        • Yangzhou First People's Hospital
        • Contact:
          • Tieyu Tang
    • Jiangxi
      • Jiujiang, Jiangxi, China
        • Recruiting
        • Jiujiang University Affiliated Hospital
        • Contact:
          • Xiangbin Wu
      • Nanchang, Jiangxi, China
        • Recruiting
        • The Second Affiliated Hopsital of Nanchang University
        • Contact:
          • Zhenyu Tang
    • Jilin
      • Changchun, Jilin, China
        • Recruiting
        • The First Bethune Hospital of Jilin University
        • Contact:
          • Li Sun
    • Neimenggu
      • Hohhot, Neimenggu, China
        • Not yet recruiting
        • Inner Mongolia International Hospital of Mongolian Medicine
        • Contact:
          • Qile Temu
    • Shandong
      • Jinan, Shandong, China
        • Not yet recruiting
        • Shandong Provincial Hospital
        • Contact:
          • Yifeng Du
      • Jinan, Shandong, China
        • Not yet recruiting
        • Qilu Hospital of Shandong University
        • Contact:
          • Yi Li
      • Qingdao, Shandong, China
        • Not yet recruiting
        • The Affiliated Hospital of Qingdao University
        • Contact:
          • Yanping Sun
      • Qingdao, Shandong, China
        • Not yet recruiting
        • Qilu Hospital of Shandong University (Qingdao)
        • Contact:
          • Chuanzhu Yan
      • Yantai, Shandong, China
        • Not yet recruiting
        • Yantai Yuhuangding Hospital
        • Contact:
          • Zhigang Liang
    • Shanghai
      • Shanghai, Shanghai, China
        • Not yet recruiting
        • Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
        • Contact:
          • Jianren Liu
    • Shanxi
      • Xi'an, Shanxi, China
        • Not yet recruiting
        • Xi'an Mental Health Center
        • Contact:
          • Wei Dang
      • Xi'an, Shanxi, China
        • Not yet recruiting
        • The Second Affiliated Hospital of Air Force Medical University （Tangdu Hospital of Air Force Medical University）
        • Contact:
          • Wei Zhang
      • Xianyang, Shanxi, China
        • Not yet recruiting
        • Xianyang Hospital of Yan'an University
        • Contact:
          • Aihong Guo
    • Sichuan
      • Chengdu, Sichuan, China
        • Not yet recruiting
        • Hospital of Chengdu University of TCM
        • Contact:
          • Dongdong Yang
    • Tianjin
      • Tianjin, Tianjin, China
        • Not yet recruiting
        • Tianjin People's Hospital
        • Contact:
          • Meiyun Zhang
    • Xinjiang
      • Urumqi, Xinjiang, China
        • Not yet recruiting
        • The Affiliated Hopsital of Inner Mongolia Medical University
        • Contact:
          • Chunyang Li
    • Yunnan
      • Kunming, Yunnan, China
        • Not yet recruiting
        • First Affiliated Hospital of Kunming Medical University
        • Contact:
          • Xiufeng Xu
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Not yet recruiting
        • The First Affiliated Hospital Zhejiang University School of Medicine
        • Contact:
          • Guoping Peng
      • Jiaxing, Zhejiang, China
        • Recruiting
        • The Second Hospital of Jiaxing
        • Contact:
          • Yanping Wang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Mild to moderate AD per NIA-AA.
  • History of cognitive and functional decline over at least 1 year.
  • MMSE scores between 11 and 24 (inclusive) at baseline.
  • Hachinski Ischemic Score (HIS) scale total score ≤ 4.
  • Hamilton Rating Scale for Depression/17 items (HAMD) total score ≤ 10.
  • Brain MRI scan show the highest possibility of AD.
  • Have a reliable study partner/caregiver.
  • Sign the informed consent form.

Exclusion Criteria:

  • Diagnosis of a dementia-related central nervous system disease other than AD.
  • Major structural brain disease as judged by MRI.
  • A resting heart rate of < 50 beats per minute (bpm) after 10 minutes of rest.
  • Major medical illness or unstable medical condition within 12 months of screening.
  • Concomitant use of donepezil, rivastigmine, galanthamine, huperzine A, memantine, or aducanumab within 6 moinths prior to baseline.
  • Inadequate hepatic function.
  • Inadequate organ function.
  • ECG clinically significant abnormalities.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Administered PO
Experimental: GV-971
Drug: GV-971
Administered PO

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in the ADAS-cog/12 score
Time Frame: Baseline, 36 weeks
Change from baseline in Alzheimer's Disease Assessments Scale - cognitive (ADAS-cog/12) scale total score. The total score of ADAS-cog/12 is 0-75, with higher scores mean a worse outcome.
Baseline, 36 weeks
Change from baseline in ADCS-ADL23 score
Time Frame: Baseline, 36 weeks
Change from baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living-23-item Scale (ADCS-ADL23) score in moderate AD participants. The total score of ADCS-ADL23 is 0-78, with higher scores mean a better outcome.
Baseline, 36 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in MMSE score
Time Frame: Baseline, 36 weeks
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, 36 weeks
Change from baseline in the CIBIC-Plus score
Time Frame: Baseline, 36 weeks
Change from baseline on Clinician's Interview-Based Impression of Change Plus (CIBIC-Plus) scale total score. The total score of CIBIC-Plus is 1-7, with higher scores mean a worse outcome.
Baseline, 36 weeks
Change from baseline in NPI score
Time Frame: Baseline, 36 weeks
Change from baseline in Neuropsychiatric Inventory (NPI) score. The total score of NPI is 0-144, with higher scores mean a worse outcome.
Baseline, 36 weeks
Change from baseline in ADCS-ADL23 score
Time Frame: Baseline, 36 weeks
Change from baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living-23-item Scale (ADCS-ADL23) score. The total score of ADCS-ADL23 is 0-78, with higher scores mean a better outcome.
Baseline, 36 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline on A-beta protein of CSF
Time Frame: Baseline, 36 weeks
Change from baseline on biomarkers of CSF A-beta protein after 36 weeks of treatment.
Baseline, 36 weeks
Change from baseline on Tau protein of CSF
Time Frame: Baseline, 36 weeks
Change from baseline on biomarkers of CSF Tau protein after 36 weeks of treatment.
Baseline, 36 weeks
Change from baseline on biomarkers of Th1/Th2 cell subtypes
Time Frame: Baseline, 36 weeks
Change from baseline on biomarkers of peripheral blood immune cell subtypes of Th1/Th2 after 36 weeks of treatment.
Baseline, 36 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Green Valley (Shanghai) Pharmaceuticals Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 31, 2023

Primary Completion (Estimated)

June 1, 2029

Study Completion (Estimated)

December 1, 2029

Study Registration Dates

First Submitted

May 31, 2023

First Submitted That Met QC Criteria

June 8, 2023

First Posted (Actual)

June 18, 2023

Study Record Updates

Last Update Posted (Estimated)

November 9, 2023

Last Update Submitted That Met QC Criteria

November 8, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GV-971-PoCT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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