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NCT05908695RecruitingPhase 4

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

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

Source: ClinicalTrials.gov · Last updated 9 Nov 2023 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
1312 (estimated)
First submitted
31 May 2023
Start date
31 Aug 2023
Primary completion date
Jun 2029
Lead sponsor
Green Valley (Shanghai) Pharmaceuticals Co., Ltd.
NCT number
NCT05908695

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 1312
  • From 31 Aug 2023 to the primary completion date, Jun 2029
  • 50 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Concomitant use of donepezil, rivastigmine, galanthamine, huperzine A, memantine, or aducanumab within 6 moinths prior to baseline.

Other illness

  • 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.

Other

  • Inadequate hepatic function.
  • Inadequate organ function.
  • ECG clinically significant abnormalities.

Who the study is looking for

  • 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.

Age in the registry: 50 years to 85 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (50)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Beijing Anding Hospital, Capital Medical University
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BeijingChinaNot yet recruiting
Beijing Hospital
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BeijingChinaNot yet recruiting
Xuanwu Hospital, Capital Medical University
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BeijingChinaRecruiting
Beijing Anzhen Hospital, Capital Medical University
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BeijingChinaNot yet recruiting
Beijing Tongren Hospital, Capital Medical University
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BeijingChinaNot yet recruiting
Peking University Shougang Hospital
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BeijingChinaNot yet recruiting
The First Medical Center, Chinese PLA General Hospital
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BeijingChinaNot yet recruiting
The First Bethune Hospital of Jilin University
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ChangchunChinaRecruiting
The Third Xiangya Hospital of Central South University
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ChangshaChinaNot yet recruiting
Xiangya Hospital Central South University
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ChangshaChinaNot yet recruiting
Hospital of Chengdu University of TCM
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ChengduChinaNot yet recruiting
Chenzhou First People's Hospital
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ChenzhouChinaNot yet recruiting
The Second Affiliated Hopsital of Guangzhou Medical University
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GuangzhouChinaRecruiting
Guangdong Provincial Hospital of Chinese Medicine
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GuangzhouChinaNot yet recruiting
The First Affiliated Hopsital of Guangzhou Medical University
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GuangzhouChinaNot yet recruiting
The Affiliated Brain Hospital of Guangzhou Medical University
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GuangzhouChinaNot yet recruiting
The First Affiliated Hospital Zhejiang University School of Medicine
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HangzhouChinaNot yet recruiting
Inner Mongolia International Hospital of Mongolian Medicine
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HohhotChinaNot yet recruiting
Huai'an Second People's Hospital
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Huai'anChinaNot yet recruiting
Huainan First People's Hospital
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HuainanChinaRecruiting
The Second Hospital of Jiaxing
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JiaxingChinaRecruiting
Qilu Hospital of Shandong University
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JinanChinaNot yet recruiting
Shandong Provincial Hospital
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JinanChinaNot yet recruiting
Jiujiang University Affiliated Hospital
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JiujiangChinaRecruiting
First Affiliated Hospital of Kunming Medical University
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KunmingChinaNot yet recruiting
The Second Affiliated Hopsital of Nanchang University
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NanchangChinaRecruiting
Nanjing Brain Hospital
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NanjingChinaNot yet recruiting
The First People's Hospital of Nanning
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NanningChinaRecruiting
Affiliated Hospital of Nantong University
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NantongChinaNot yet recruiting
The First Affiliated Hopsital of Nanyang Medical College
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NanyangChinaNot yet recruiting
The Affiliated Hospital of Qingdao University
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QingdaoChinaNot yet recruiting
Qilu Hospital of Shandong University (Qingdao)
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QingdaoChinaNot yet recruiting
Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
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ShanghaiChinaNot yet recruiting
Peking University Shenzhen Hospital
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ShenzhenChinaNot yet recruiting
The First Hospital of Hebei Medical University
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ShijiazhuangChinaRecruiting
Shijiazhuang People's Hospital
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ShijiazhuangChinaRecruiting
The Second Hopsital of Hebei Medical University
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ShijiazhuangChinaNot yet recruiting
Tangshan Workers' Hospital
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TangshanChinaRecruiting
Tianjin People's Hospital
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TianjinChinaNot yet recruiting
The Affiliated Hopsital of Inner Mongolia Medical University
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ÜrümqiChinaNot yet recruiting
Wuhan Hospital of Traditional Chinese and Western Medicine (Wuhan No.1 Hospital)
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WuhanChinaNot yet recruiting
The First Affiliated Hopsital of Xiamen University
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XiamenChinaNot yet recruiting
Xi'an Mental Health Center
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Xi’anChinaNot yet recruiting
The Second Affiliated Hospital of Air Force Medical University (Tangdu Hospital of Air Force Medical University)
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Xi’anChinaNot yet recruiting
Xianyang Hospital of Yan'an University
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XianyangChinaNot yet recruiting
The affiliated hospital of xuzhou medical university
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XuzhouChinaRecruiting
Yangzhou First People's Hospital
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YangzhouChinaNot yet recruiting
Yantai Yuhuangding Hospital
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YantaiChinaNot yet recruiting
Yueyang Central Hospital
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YueyangChinaNot yet recruiting
Henan Provincial People's Hospital
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ZhengzhouChinaNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.