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NCT04520412SuspendedPhase 3

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

A Phase 3, Multi-center, Randomized, Double-blind, Parallel-group, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of Sodium Oligomannate (GV-971) in Treatment of Mild to Moderate Alzheimer's Disease (GREEN MEMORY: GREen Valley 971 EvaluatioN Memory)

Source: ClinicalTrials.gov · Last updated 23 Nov 2022

Reason given: The quality of study was seriously affected by the COVID-19, so it was decided to suspend the trial and restart it at the right time.

Brief summary (registry, in English)

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

Status (registry)
Suspended
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
2046 (estimated)
First submitted
11 Aug 2020
Start date
27 Oct 2020
Primary completion date
Dec 2025
Lead sponsor
Green Valley (Shanghai) Pharmaceuticals Co., Ltd.
NCT number
NCT04520412

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 AChEIs and/or memantine within 30 days before first MMSE score, and during the study.

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 5 minutes of rest in sitting or supine position.
  • Major medical illness or unstable medical condition within 6 months of screening.

Other

  • Inadequate hepatic function.
  • Inadequate organ and marrow 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.
  • Brain MRI scan show the highest possibility of AD.
  • Have a study partner/caregiver.

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

Full criteria on ClinicalTrials.gov

Sites (171)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Hornsby Ku-ring-gai HospitalHornsbyAustraliaUnknown status
KaRa MINDSMacquarie ParkAustraliaUnknown status
Austin Health - Heidelberg Repatriation HospitalMelbourneAustraliaUnknown status
Alzheimer's Research FoundationNedlandsAustraliaUnknown status
Heritage Medical Research ClinicCalgaryCanadaUnknown status
Clinique Memoire OutaouaisGatineauCanadaUnknown status
True North Clinical Research IncHalifaxCanadaUnknown status
The Medical Arts Health Research GroupKamloopsCanadaUnknown status
MedicalArtsHealth Research GrpKelownaCanadaUnknown status
Okanagan Clinical TrialsKelownaCanadaUnknown status
True North Clinical ResearchNew MinasCanadaUnknown status
Recherches Neuro-Hippocampe, Inc., d/b/a Ottawa Memory ClinicOttawaCanadaUnknown status
MedicalArtsHealth Research GrpPentictonCanadaUnknown status
Alpha Recherche CliniqueQuébecCanadaUnknown status
Diex Recherche SherbrookeSherbrookeCanadaUnknown status
Q&T Research Sherbrooke Inc.SherbrookeCanadaUnknown status
Toronto Western HospitalTorontoCanadaUnknown status
Toronto Memory ProgramTorontoCanadaUnknown status
Douglas Hospital Research CentreVerdunCanadaUnknown status
Vancouver Island Health AuthorityVictoriaCanadaUnknown status
Medical Arts Health Research GrpWest VancouverCanadaUnknown status
Beijing Tong Ren HospitalBeijingChinaUnknown status
Xuanwu HospitalBeijingChinaUnknown status
Peking Union HospitalBeijingChinaUnknown status
Beijing HospitalBeijingChinaUnknown status
Peking University 1st HospitalBeijingChinaUnknown status
Beijing Tiantan HospitalBeijingChinaUnknown status
Beijing Anding HospitalBeijingChinaUnknown status
1st Hospital Jilin UniversityChangchunChinaUnknown status
Xiangya HospitalChangshaChinaUnknown status
West China HospitalChengduChinaUnknown status
1st Hospital of Chongqing MUChongqingChinaUnknown status
1st Hospital of Fujian MUFuzhouChinaUnknown status
Fujian Union HospitalFuzhouChinaUnknown status
1st Hospital of Guangzhou MUGuangzhouChinaUnknown status
2nd Hospital of Guangzhou MUGuangzhouChinaUnknown status
Guangzhou 1st People's HospitalGuangzhouChinaUnknown status
2nd Hospital Zhongshan UniversityGuangzhouChinaUnknown status
1st Hospital Zhejiang UniversityHangzhouChinaUnknown status
Zhejiang Provincial HospitalHangzhouChinaUnknown status
1st Hospital of Anhui MUHefeiChinaUnknown status
Shandong Provincial HospitalJinanChinaUnknown status
Qilu HospitalJinanChinaUnknown status
1st Hospital of Kunming MUKunmingChinaUnknown status
Jiangxi Provincial HospitalNanchangChinaUnknown status
Zhong Da HospitalNanjingChinaUnknown status
Nanjing Drum Tower hospitalNanjingChinaUnknown status
QingDao Municipal HospitalQingdaoChinaUnknown status
Shanghai Mental Health CenterShanghaiChinaUnknown status
Huashan Hospital; Fudan UShanghaiChinaUnknown status
Ruijin hospitalShanghaiChinaUnknown status
Shanghai General HospitalShanghaiChinaUnknown status
Kangning Hospital of ShenzhenShenzhenChinaUnknown status
1st Hospital of Hebei MUShijiazhuangChinaUnknown status
2nd Hospital Soochow UniversitySuzhouChinaUnknown status
1st Hospital of Shanxi MUTaiyuanChinaUnknown status
Tangshan Gongren HospitalTangshanChinaUnknown status
Tianjin Huanhu HospitalTianjinChinaUnknown status
Tianjin MU General HospitalTianjinChinaUnknown status
1st Hospital of Wenzhou MUWenzhouChinaUnknown status
Zhongshan Hospital Xiamen UXiamenChinaUnknown status
Xi'an Mental Health CenteXi'anChinaUnknown status
Tang-Du HospitalXi’anChinaUnknown status
General Hospital of Ningxia MUYinchuanChinaUnknown status
Yueyang 1st People's HospitalYueyangChinaUnknown status
NeuropsychiatrieHK, s.r.o.Hradec KrálovéCzechiaUnknown status
Brain-Soultherapy s.r.o.KladnoCzechiaUnknown status
Neuroterapie KH S R OKutná HoraCzechiaUnknown status
Neuropsychiatrie s.r.o.PragueCzechiaUnknown status
FORBELI s.r.o.PragueCzechiaUnknown status
Clintrial S.R.O.PragueCzechiaUnknown status
Groupe Hospitalier PellegrinBordeauxFranceUnknown status
Neurologique Pierre WertheimerBronFranceUnknown status
Hôpitaux Civils de ColmarColmarFranceUnknown status
Centre Memoire RessourcesDijonFranceUnknown status
CHUTimone Adultes ServiceMarseilleFranceUnknown status
Hôpital Gui de ChauliacMontpellierFranceUnknown status
CHU Nantes - Hopital Nord LaënnecNantesFranceUnknown status
CMRR Paris NordParisFranceUnknown status
CHU Reims Hôpital Maison BlancheReimsFranceUnknown status
Pharmacie CHU de RennesRennesFranceUnknown status
Centred Investigation CliniqueStrasbourgFranceUnknown status
CHU Tours-Hopital BretonneauTonnerreFranceUnknown status
Recherche Clinique GerontopoleToulouseFranceUnknown status
Hôpital des CharpennesVilleurbanneFranceUnknown status
Prince of Wales HospitalShatinHong KongUnknown status
VUMC GoederenontvangstAmsterdamNetherlandsUnknown status
Amphia Hospital BredaBredaNetherlandsUnknown status
Pharmacy Jeroen Bosch Ziekenhuis's-HertogenboschNetherlandsUnknown status
Klinische FarmacieZwolleNetherlandsUnknown status
Podlaskie Centrum PsychogeriatriBialystokPolandUnknown status
NZOZ VitamedBydgoszczPolandUnknown status
Nzoz Novo-MedKatowicePolandUnknown status
Wielospec. Poradnia LekarskaKatowicePolandUnknown status
Specjalistyczne Gabinety Sp.zo.oKrakowPolandUnknown status
NZOZ Neuromed MiMNastajSppLublinPolandUnknown status
Medicome Sp. z o.o.OswiecimPolandUnknown status
Solumed Centrum MedycznePoznanPolandUnknown status
Neuro ProtectWarsawPolandUnknown status
Wrclawskie Cntrm AlzheimerowskieWroclawPolandUnknown status
Wielospecjalistyczne Centrm MedZabrzePolandUnknown status
Tri-Service General HospitalTaipeiTaiwanUnknown status
National Taiwan UniversityHospTaipeiTaiwanUnknown status
Chang GungMemorial Hosp LinkouTaoyuanTaiwanUnknown status
Abington Neurological Associates, LtdAbingtonUnited StatesUnknown status
JEM Research LLCAtlantisUnited StatesUnknown status
Insight Clinical Trials LLCBeachwoodUnited StatesUnknown status
Integrative Clinical Trials, LLCBrooklynUnited StatesUnknown status
UBMD NeurologyBuffaloUnited StatesUnknown status
SCarolina Institute Brain HealthCharlestonUnited StatesUnknown status
AMC Research, LLCCharlotteUnited StatesUnknown status
Behavioral Health Research CenterCharlotteUnited StatesUnknown status
Great Lakes Clinical TrialsChicagoUnited StatesUnknown status
New Horizons Clinical ResearchCincinnatiUnited StatesUnknown status
Cleveland Clinic FoundationClevelandUnited StatesUnknown status
Kerwin Research CenterDallasUnited StatesUnknown status
NeuroStudies.net, LLCDecaturUnited StatesUnknown status
Brain Matters ResearchDelray BeachUnited StatesUnknown status
Clarity Clinical ResearchEast SyracuseUnited StatesUnknown status
Cognition HealthFairfaxUnited StatesUnknown status
QUEST Research InstituteFarmington HillsUnited StatesUnknown status
Cognitive Clinical Trials, LLCGilbertUnited StatesUnknown status
Finlay Medical Research CorpGreenacres CityUnited StatesUnknown status
Guilford Neurologic AssociateGreensboroUnited StatesUnknown status
Velocity Clinical ResearchHallandaleUnited StatesUnknown status
Huston Methodist HospitalHoustonUnited StatesUnknown status
Indiana UniversityIndianapolisUnited StatesUnknown status
Irvine Clinical ResearchIrvineUnited StatesUnknown status
Jacksonville Center for Clinical ResearchJacksonvilleUnited StatesUnknown status
Charter Research, LLCLady LakeUnited StatesUnknown status
Sunwise Clinical ResearchLafayetteUnited StatesUnknown status
Altea Research Institute, Las VegasLas VegasUnited StatesUnknown status
Innovative Clinical Research, Inc.LauderhillUnited StatesUnknown status
Activmed Practices&ResearchLawrenceUnited StatesUnknown status
Pharmacology Research InstituteLos AlamitosUnited StatesUnknown status
ClinCloud, LLCMaitlandUnited StatesUnknown status
Merritt Island Medical Research, LLCMerritt IslandUnited StatesUnknown status
Collier Neurologic SpecialistsNaplesUnited StatesUnknown status
Suncoast Clinical Research, Inc.New Port RicheyUnited StatesUnknown status
University of Nebraska Medical Center-Hematology/Oncology SectionOmahaUnited StatesUnknown status
Cognitive Clinical Trials, LLCOmahaUnited StatesUnknown status
Clinical Neuroscience Solutions, Inc.OrlandoUnited StatesUnknown status
Synexus Clinical ResearchOrlandoUnited StatesUnknown status
Neurology Associates of Ormond BeachOrmond BeachUnited StatesUnknown status
St. Joseph's Hospital and Medical CenterPhoenixUnited StatesUnknown status
Banner Alzheimer's InstitutePhoenixUnited StatesUnknown status
Quantum Lab CNS Clinical ResearchPompano BeachUnited StatesUnknown status
Summit Research Network Oregon Inc.PortlandUnited StatesUnknown status
Oregon Health&Science UniverstyPortlandUnited StatesUnknown status
Progressive Medical ResearchPort OrangeUnited StatesUnknown status
Global Medical Institutes, LLCPrincetonUnited StatesUnknown status
Clinical Trials of Texas IncSan AntonioUnited StatesUnknown status
Pacific Research NetworkSan DiegoUnited StatesUnknown status
Pacific Research Network, IncSan DiegoUnited StatesUnknown status
Syrentis Clinical ResearchSanta AnaUnited StatesUnknown status
Intercoastal Medical GroupSarasotaUnited StatesUnknown status
University Washington MedCentreSeattleUnited StatesUnknown status
Schuster Med Research InstituteSherman OaksUnited StatesUnknown status
Oregon Neurology AssociatesSpringfieldUnited StatesUnknown status
The Cognitive Research Center of New JerseySpringfieldUnited StatesUnknown status
Richmond Behavioral AssociatesStaten IslandUnited StatesUnknown status
Barnes-Jewish Hospital IDSSt LouisUnited StatesUnknown status
Banner Sun Health Research InstituteSun CityUnited StatesUnknown status
Stedman Clinical Trials, LLCTampaUnited StatesUnknown status
Meridien ResearchTampaUnited StatesUnknown status
Synexus The VillagesThe VillagesUnited StatesUnknown status
Advanced Memory Research Institute of NJ, PCToms RiverUnited StatesUnknown status
Banner Alzheimer's InstituteTucsonUnited StatesUnknown status
Columbus Neuroscience, LLCWestervilleUnited StatesUnknown status
Advanced Clinical ResearchWest JordanUnited StatesUnknown status
Alliance Multispecialty ResearchWichitaUnited StatesUnknown status

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