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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1312

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: Placebo
Administered PO
Experimental: GV-971
Drug: GV-971
Administered PO

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 31, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 31, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 18, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 9, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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