A Study of Sodium Oligomannate (GV-971) in Participants With Mild to Moderate Alzheimer's Disease

Last updated: November 18, 2022
Sponsor: Green Valley (Shanghai) Pharmaceuticals Co., Ltd.
Overall Status: Suspended

Phase

3

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT04520412
GV971-007
  • Ages 50-85
  • All Genders

Study Summary

The purpose of this study is to evaluate the safety, tolerability and efficacy of GV-971 in mild to moderate Alzheimer's disease.

Eligibility Criteria

Inclusion

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.
  • Brain MRI scan show the highest possibility of AD.
  • Have a study partner/caregiver.

Exclusion

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 5 minutes of rest in sittingor supine position.
  • Major medical illness or unstable medical condition within 6 months of screening.
  • Concomitant use of AChEIs and/or memantine within 30 days before first MMSE score, andduring the study.
  • Inadequate hepatic function.
  • Inadequate organ and marrow function.
  • ECG clinically significant abnormalities.

Study Design

Total Participants: 2046
Study Start date:
October 27, 2020
Estimated Completion Date:
October 31, 2026

Connect with a study center

  • Hornsby Ku-ring-gai Hospital

    Hornsby, New South Wales 2077
    Australia

    Site Not Available

  • KaRa MINDS

    Macquarie Park, New South Wales 2113
    Australia

    Site Not Available

  • Austin Health - Heidelberg Repatriation Hospital

    Melbourne, Victoria 3081
    Australia

    Site Not Available

  • Alzheimer's Research Foundation

    Nedlands, Western Australia 6009
    Australia

    Site Not Available

  • Heritage Medical Research Clinic

    Calgary, Alberta T2N 4Z6
    Canada

    Site Not Available

  • The Medical Arts Health Research Group

    Kamloops, British Columbia V2C 5T1
    Canada

    Site Not Available

  • MedicalArtsHealth Research Grp

    Kelowna, British Columbia V1Y 4N7
    Canada

    Site Not Available

  • Okanagan Clinical Trials

    Kelowna, British Columbia V1Y 1Z9
    Canada

    Site Not Available

  • MedicalArtsHealth Research Grp

    Penticton, British Columbia V2A 5L5
    Canada

    Site Not Available

  • Vancouver Island Health Authority

    Victoria, British Columbia V8R1J8
    Canada

    Site Not Available

  • Medical Arts Health Research Grp

    West Vancouver, British Columbia V7T 1C5
    Canada

    Site Not Available

  • True North Clinical Research Inc

    Halifax, Nova Scotia B3M 1N2
    Canada

    Site Not Available

  • True North Clinical Research

    New Minas, Nova Scotia B4N 3R7
    Canada

    Site Not Available

  • Recherches Neuro-Hippocampe Inc., d/b/a Ottawa Memory Clinic

    Ottawa, Ontario K1Z 1G3
    Canada

    Site Not Available

  • Toronto Memory Program

    Toronto, Ontario M3B 2S7
    Canada

    Site Not Available

  • Toronto Western Hospital

    Toronto, Ontario M5T 2S8
    Canada

    Site Not Available

  • Clinique Memoire Outaouais

    Gatineau, Quebec J8T 8J1
    Canada

    Site Not Available

  • Diex Recherche Sherbrooke

    Sherbrooke, Quebec J1L0H8
    Canada

    Site Not Available

  • Q & T Research Sherbrooke Inc

    Sherbrooke, Quebec J1J 2G2
    Canada

    Site Not Available

  • Douglas Hospital Research Centre

    Verdun, Quebec H4H 1R3
    Canada

    Site Not Available

  • True North Clinical Research/Site 1011

    Nova Scotia, B4N 3R7
    Canada

    Site Not Available

  • ALPHA Recherche Clinique

    Quebec, Qc G3K 2P8
    Canada

    Site Not Available

  • 1st Hospital of Anhui MU

    Hefei, Anhui 230022
    China

    Site Not Available

  • Beijing Anding Hospital

    Beijing, Beijing 100088
    China

    Site Not Available

  • Beijing Hospital

    Beijing, Beijing 100730
    China

    Site Not Available

  • Beijing Tiantan Hospital

    Beijing, Beijing 100070
    China

    Site Not Available

  • Beijing Tong Ren Hospital

    Beijing, Beijing 100730
    China

    Site Not Available

  • Peking Union Hospital

    Beijing, Beijing 100032
    China

    Site Not Available

  • Peking University 1st Hospital

    Beijing, Beijing 100034
    China

    Site Not Available

  • Xuanwu Hospital

    Beijing, Beijing 100053
    China

    Site Not Available

  • 1st Hospital of Chongqing MU

    Chongqing, Chongqing 400016
    China

    Site Not Available

  • 1st Hospital of Fujian MU

    Fuzhou, Fujian 350005
    China

    Site Not Available

  • Fujian Union Hospital

    Fuzhou, Fujian 350001
    China

    Site Not Available

  • Zhongshan Hospital Xiamen U

    Xiamen, Fujian 361004
    China

    Site Not Available

  • 1st Hospital of Guangzhou MU

    Guangzhou, Guangdong 510120
    China

    Site Not Available

  • 2nd Hospital Zhongshan University

    Guangzhou, Guangdong 510260
    China

    Site Not Available

  • 2nd Hospital of Guangzhou MU

    Guangzhou, Guangdong 510260
    China

    Site Not Available

  • Guangzhou 1st People's Hospital

    Guangzhou, Guangdong 510180
    China

    Site Not Available

  • Kangning Hospital of Shenzhen

    Shenzhen, Guangdong 518118
    China

    Site Not Available

  • 1st Hospital of Hebei MU

    Shijiazhuang, Hebei 50030
    China

    Site Not Available

  • Tangshan Gongren Hospital

    Tangshan, Hebei 63000
    China

    Site Not Available

  • Xiangya Hospital

    Changsha, Hunan 410008
    China

    Site Not Available

  • Yueyang 1st People's Hospital

    Yueyang, Hunan 414000
    China

    Site Not Available

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu 210000
    China

    Site Not Available

  • Zhong Da Hospital

    Nanjing, Jiangsu 210009
    China

    Site Not Available

  • 2nd Hospital Soochow University

    Suzhou, Jiangsu 215004
    China

    Site Not Available

  • Jiangxi Provincial Hospital

    Nanchang, Jiangxi 330006
    China

    Site Not Available

  • 1st Hospital Jilin University

    Changchun, Jilin 130021
    China

    Site Not Available

  • General Hospital of Ningxia MU

    Yinchuan, Ningxia Hui Autonomous Region 750004
    China

    Site Not Available

  • Tang Du Hospital

    Xi'an, Shaanxi 710038
    China

    Site Not Available

  • Xi'an Mental Health Cente

    Xi'an, Shaanxi 710061
    China

    Site Not Available

  • Qilu Hospital

    Jinan, Shandong 250012
    China

    Site Not Available

  • Shandong Provincial Hospital

    Jinan, Shandong 250021
    China

    Site Not Available

  • Qingdao Municipal Hospital

    Qingdao, Shandong 266071
    China

    Site Not Available

  • Huashan Hospital; Fudan U

    Shanghai, Shanghai 200040
    China

    Site Not Available

  • Ruijin Hospital

    Shanghai, Shanghai 200020
    China

    Site Not Available

  • Shanghai General Hospital

    Shanghai, Shanghai 200080
    China

    Site Not Available

  • Shanghai Mental Health Center

    Shanghai, Shanghai 200030
    China

    Site Not Available

  • 1st Hospital of Shanxi MU

    Taiyuan, Shanxi 30001
    China

    Site Not Available

  • West China Hospital

    Chengdu, Sichuan 610041
    China

    Site Not Available

  • Tianjin Huanhu Hospital

    Tianjin, Tianjin 300060
    China

    Site Not Available

  • Tianjin MU General Hospital

    Tianjin, Tianjin 300052
    China

    Site Not Available

  • 1st Hospital of Kunming MU

    Kunming, Yunnan 650032
    China

    Site Not Available

  • 1st Hospital Zhejiang University

    Hangzhou, Zhejiang 310003
    China

    Site Not Available

  • Zhejiang Provincial Hospital

    Hangzhou, Zhejiang 310000
    China

    Site Not Available

  • 1st Hospital of Wenzhou MU

    Wenzhou, Zhejiang 325000
    China

    Site Not Available

  • NeuropsychiatrieHK s.r.o.

    Hradec Králové, 50341
    Czechia

    Site Not Available

  • BRAIN-SOULTHERAPY s.r.o.

    Kladno, 27204
    Czechia

    Site Not Available

  • Neuroterapie KH s.r.o.

    Kutná Hora, 28401
    Czechia

    Site Not Available

  • FORBELI s.r.o.

    Praha, 16000
    Czechia

    Site Not Available

  • Neuropsychiatrie s.r.o.

    Praha, 16100
    Czechia

    Site Not Available

  • Clintrial s.r.o.

    Praha 10, 10100
    Czechia

    Site Not Available

  • Centred Investigation Clinique

    Strasbourg, Bas Rhin 67098
    France

    Site Not Available

  • CHUTimone Adultes Service

    Marseille, Bouches-du-Rhône 13005
    France

    Site Not Available

  • HOPITAL Gui de CHAULIAC

    Montpellier, Cedex 5 34295
    France

    Site Not Available

  • Centre Memoire Ressources

    Dijon, De Lattre De Tassigny 21000
    France

    Site Not Available

  • Groupe Hospitalier Pellegrin

    Bordeaux, Gironde 33076
    France

    Site Not Available

  • Hopitaux Civils de Colmar

    Colmar, Grand Est 68024
    France

    Site Not Available

  • Recherche Clinique Gerontopole

    Toulouse, Haute Garonne 31059
    France

    Site Not Available

  • Pharmacie CHU de Rennes

    Rennes, Ille Et Vilaine 35033
    France

    Site Not Available

  • CHU Tours-Hopital Bretonneau

    Tonnerre, Indre Et Loire 37044
    France

    Site Not Available

  • CHU Nantes-Hopital Nord Laennec

    Nantes, Loire Atlantique 44093
    France

    Site Not Available

  • CHU Reims-Hopital Maison Blanche

    Reims, Marne 51092
    France

    Site Not Available

  • Neurologique Pierre Wertheimer

    Bron, Rhone 69677
    France

    Site Not Available

  • Hopital des Charpennes

    Villeurbanne, Rhone 69100
    France

    Site Not Available

  • CMRR Paris Nord

    Paris, 75010
    France

    Site Not Available

  • Prince of Wales Hospital

    Shatin,
    Hong Kong

    Site Not Available

  • VUmc Goederenontvangst

    Amsterdam, Van Der Boechorststraat 6 1081 GN
    Netherlands

    Site Not Available

  • Amphia Hospital Breda

    Breda, 4818 C.K
    Netherlands

    Site Not Available

  • Pharmacy Jeroen Bosch Ziekenhuis

    Herzogenbusch, 5223 LA
    Netherlands

    Site Not Available

  • Klinische Farmacie

    Zwolle, 8025 AB
    Netherlands

    Site Not Available

  • Podlaskie Centrum Psychogeriatri

    Bialystok, 15-756
    Poland

    Site Not Available

  • NZOZ Vitamed

    Bydgoszcz, 85-079
    Poland

    Site Not Available

  • Nzoz Novo Med

    Katowice, 40-650
    Poland

    Site Not Available

  • Wielospec. Poradnia Lekarska

    Katowice, 40-123
    Poland

    Site Not Available

  • Specjalistyczne Gabinety Sp.zo.o

    Kraków, 30-539
    Poland

    Site Not Available

  • NZOZ Neuromed MiMNastajSpp

    Lublin, 20-064
    Poland

    Site Not Available

  • Medicome Sp z o o

    Oświęcim, 32-600
    Poland

    Site Not Available

  • Solumed Centrum Medyczne

    Poznań, 60-529
    Poland

    Site Not Available

  • Neuro Protect

    Warszawa, 01-684
    Poland

    Site Not Available

  • Wrclawskie Cntrm Alzheimerowskie

    Wrocław, 53659
    Poland

    Site Not Available

  • Wielospecjalistyczne Centrm Med

    Zabrze, 41-800
    Poland

    Site Not Available

  • National Taiwan UniversityHosp

    Taipei, 10048
    Taiwan

    Site Not Available

  • Tri Service General Hospital

    Taipei, 11490
    Taiwan

    Site Not Available

  • Chang GungMemorial Hosp Linkou

    Taoyuan, 333
    Taiwan

    Site Not Available

  • Cognitive Clinical Trials, LLC

    Gilbert, Arizona 85297
    United States

    Site Not Available

  • Banner Alzheimer's Institute

    Phoenix, Arizona 85006
    United States

    Site Not Available

  • St. Joseph's Hospital and Medical Center

    Phoenix, Arizona 85013
    United States

    Site Not Available

  • Banner Sun Health Research Institute

    Sun City, Arizona 85351
    United States

    Site Not Available

  • Banner Alzheimer's Institute

    Tucson, Arizona 85718
    United States

    Site Not Available

  • Irvine Clinical Research

    Irvine, California 92614
    United States

    Site Not Available

  • Sunwise Clinical Research

    Lafayette, California 94549
    United States

    Site Not Available

  • Pharmacology Research Institute

    Los Alamitos, California 90720
    United States

    Site Not Available

  • Pacific Research Network

    San Diego, California 92103
    United States

    Site Not Available

  • Pacific Research Network, Inc

    San Diego, California 92103
    United States

    Site Not Available

  • Syrentis Clinical Research

    Santa Ana, California 92705
    United States

    Site Not Available

  • Schuster Med Research Institute

    Sherman Oaks, California 91403
    United States

    Site Not Available

  • JEM Research LLC

    Atlantis, Florida 33462
    United States

    Site Not Available

  • Brain Matters Research

    Delray Beach, Florida 33445
    United States

    Site Not Available

  • Finlay Medical Research Corp

    Greenacres City, Florida 33467
    United States

    Site Not Available

  • Velocity Clinical Research

    Hallandale Beach, Florida 33009
    United States

    Site Not Available

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida 32216
    United States

    Site Not Available

  • Charter Research, LLC

    Lady Lake, Florida 32159
    United States

    Site Not Available

  • Innovative Clinical Research, Inc.

    Lauderhill, Florida 33319
    United States

    Site Not Available

  • ClinCloud, LLC

    Maitland, Florida 32751
    United States

    Site Not Available

  • Merritt Island Medical Research, LLC

    Merritt Island, Florida 32952
    United States

    Site Not Available

  • Collier Neurologic Specialists

    Naples, Florida 34105
    United States

    Site Not Available

  • Suncoast Clinical Research Inc.

    New Port Richey, Florida 34652
    United States

    Site Not Available

  • Clinical Neuroscience Solutions, Inc.

    Orlando, Florida 32801
    United States

    Site Not Available

  • Synexus Clinical Research

    Orlando, Florida 32806
    United States

    Site Not Available

  • Neurology Associates of Ormond Beach

    Ormond Beach, Florida 32174
    United States

    Site Not Available

  • Quantum Lab CNS Clinical Research

    Pompano Beach, Florida 33064
    United States

    Site Not Available

  • Progressive Medical Research

    Port Orange, Florida 32127
    United States

    Site Not Available

  • Intercoastal Medical Group

    Sarasota, Florida 34239
    United States

    Site Not Available

  • Meridien Research

    Tampa, Florida 33634
    United States

    Site Not Available

  • Stedman Clinical Trials, LLC

    Tampa, Florida 33613
    United States

    Site Not Available

  • Synexus The Villages

    The Villages, Florida 32162
    United States

    Site Not Available

  • NeuroStudies.net, LLC

    Decatur, Georgia 30033
    United States

    Site Not Available

  • Great Lakes Clinical Trials

    Chicago, Illinois 60640
    United States

    Site Not Available

  • Indiana University

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Alliance Multispecialty Research

    Wichita, Kansas 67207
    United States

    Site Not Available

  • Activmed Practices&Research

    Lawrence, Massachusetts 01843
    United States

    Site Not Available

  • Quest Research Institute

    Farmington Hills, Michigan 48334
    United States

    Site Not Available

  • Barnes-Jewish Hospital IDS

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Cognitive Clinical Trials, LLC

    Omaha, Nebraska 68130
    United States

    Site Not Available

  • University of Nebraska Medical Center-Hematology/Oncology Section

    Omaha, Nebraska 68106
    United States

    Site Not Available

  • Altea Research Institute, Las Vegas

    Las Vegas, Nevada 89102
    United States

    Site Not Available

  • Global Medical Institutes, LLC

    Princeton, New Jersey 08540
    United States

    Site Not Available

  • The Cognitive Research Center of New Jersey

    Springfield, New Jersey 07081
    United States

    Site Not Available

  • Advanced Memory Research Institute of NJ, PC

    Toms River, New Jersey 08755
    United States

    Site Not Available

  • Integrative Clinical Trials LLC

    Brooklyn, New York 11229
    United States

    Site Not Available

  • UBMD Neurology

    Buffalo, New York 14203
    United States

    Site Not Available

  • Clarity Clinical Research

    East Syracuse, New York 13057
    United States

    Site Not Available

  • Richmond Behavioral Associates

    Staten Island, New York 10312
    United States

    Site Not Available

  • AMC Research, LLC

    Charlotte, North Carolina 28270
    United States

    Site Not Available

  • Behavioral Health Research Center

    Charlotte, North Carolina 28211
    United States

    Site Not Available

  • Guilford Neurologic Associate

    Greensboro, North Carolina 27405
    United States

    Site Not Available

  • AMC Research, LLC / Site 1123

    Matthews, North Carolina 28105
    United States

    Site Not Available

  • Insight Clinical Trials LLC

    Beachwood, Ohio 44122
    United States

    Site Not Available

  • New Horizons Clinical Research

    Cincinnati, Ohio 45040
    United States

    Site Not Available

  • Cleveland Clinic Foundation

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Cleveland Clinic Foundation/Site 1169

    Lakewood, Ohio 44107
    United States

    Site Not Available

  • Columbus Neuroscience, LLC

    Westerville, Ohio 43082
    United States

    Site Not Available

  • Oregon Health&Science Universty

    Portland, Oregon 97239
    United States

    Site Not Available

  • Summit Research Network(Oregon)Inc.

    Portland, Oregon 97210
    United States

    Site Not Available

  • Oregon Neurology Associates

    Springfield, Oregon 97477
    United States

    Site Not Available

  • Abington Neurological Associates, LTD

    Abington, Pennsylvania 19001
    United States

    Site Not Available

  • SCarolina Institute Brain Health

    Charleston, South Carolina 29401
    United States

    Site Not Available

  • Kerwin Research Center

    Dallas, Texas 75231
    United States

    Site Not Available

  • Huston Methodist Hospital

    Houston, Texas 77030
    United States

    Site Not Available

  • Clinical Trials of Texas; Inc

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Advanced Clinical Research

    West Jordan, Utah 84088
    United States

    Site Not Available

  • Cognition Health

    Fairfax, Virginia 22031
    United States

    Site Not Available

  • University Washington MedCentre

    Seattle, Washington 98104-2499
    United States

    Site Not Available

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