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Alzheimer DiseasePhase 3GREEN MEMORYNCT04520412

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

A Phase 3 study testing GV-971 in people with Alzheimer Disease, run by Green Valley (Shanghai) Pharmaceuticals Co., Ltd. at 171 sites in 10 countries.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
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Trial summary

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

Who is it for?
Ages 50 to 85 years
Conditions the study is for
Alzheimer Disease
What is being tested?
GV-971
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,046 participants
Where
171 sitesin 10 countries
Study dates
27 Oct 2020to Oct 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
  • Concomitant use of AChEIs and/or memantine within 30 days before first MMSE score, and during the study.
  • Inadequate hepatic function.
  • Inadequate organ and marrow function.
  • ECG clinically significant abnormalities.

Trial locations and contacts

171 sites in 10 countries.

171 sites in 10 countries

United States67 sites

  • Abington Neurological Associates, LTD

    Abington, Pennsylvania, 19001

  • JEM Research LLC

    Atlantis, Florida, 33462

  • Insight Clinical Trials LLC

    Beachwood, Ohio, 44122

  • Integrative Clinical Trials LLC

    Brooklyn, New York, 11229

  • UBMD Neurology

    Buffalo, New York, 14203

  • SCarolina Institute Brain Health

    Charleston, South Carolina, 29401

  • Behavioral Health Research Center

    Charlotte, North Carolina, 28211

  • AMC Research, LLC

    Charlotte, North Carolina, 28270

  • Great Lakes Clinical Trials

    Chicago, Illinois, 60640

  • New Horizons Clinical Research

    Cincinnati, Ohio, 45040

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Kerwin Research Center

    Dallas, Texas, 75231

  • NeuroStudies.net, LLC

    Decatur, Georgia, 30033

  • Brain Matters Research

    Delray Beach, Florida, 33445

  • Clarity Clinical Research

    East Syracuse, New York, 13057

  • Cognition Health

    Fairfax, Virginia, 22031

  • Quest Research Institute

    Farmington Hills, Michigan, 48334

  • Cognitive Clinical Trials, LLC

    Gilbert, Arizona, 85297

  • Finlay Medical Research Corp

    Greenacres City, Florida, 33467

  • Guilford Neurologic Associate

    Greensboro, North Carolina, 27405

  • Velocity Clinical Research

    Hallandale, Florida, 33009

  • Huston Methodist Hospital

    Houston, Texas, 77030

  • Indiana University

    Indianapolis, Indiana, 46202

  • Irvine Clinical Research

    Irvine, California, 92614

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida, 32216

  • Charter Research, LLC

    Lady Lake, Florida, 32159

  • Sunwise Clinical Research

    Lafayette, California, 94549

  • Altea Research Institute, Las Vegas

    Las Vegas, Nevada, 89102

  • Innovative Clinical Research, Inc.

    Lauderhill, Florida, 33319

  • Activmed Practices&Research

    Lawrence, Massachusetts, 01843

  • Pharmacology Research Institute

    Los Alamitos, California, 90720

  • ClinCloud, LLC

    Maitland, Florida, 32751

  • Merritt Island Medical Research, LLC

    Merritt Island, Florida, 32952

  • Collier Neurologic Specialists

    Naples, Florida, 34105

  • Suncoast Clinical Research Inc.

    New Port Richey, Florida, 34652

  • University of Nebraska Medical Center-Hematology/Oncology Section

    Omaha, Nebraska, 68106

  • Cognitive Clinical Trials, LLC

    Omaha, Nebraska, 68130

  • Clinical Neuroscience Solutions, Inc.

    Orlando, Florida, 32801

  • Synexus Clinical Research

    Orlando, Florida, 32806

  • Neurology Associates of Ormond Beach

    Ormond Beach, Florida, 32174

  • Banner Alzheimer's Institute

    Phoenix, Arizona, 85006

  • St. Joseph's Hospital and Medical Center

    Phoenix, Arizona, 85013

  • Quantum Lab CNS Clinical Research

    Pompano Beach, Florida, 33064

  • Progressive Medical Research

    Port Orange, Florida, 32127

  • Summit Research Network(Oregon)Inc.

    Portland, Oregon, 97210

  • Oregon Health&Science Universty

    Portland, Oregon, 97239

  • Global Medical Institutes, LLC

    Princeton, New Jersey, 08540

  • Clinical Trials of Texas; Inc

    San Antonio, Texas, 78229

  • Pacific Research Network, Inc

    San Diego, California, 92103

  • Pacific Research Network

    San Diego, California, 92103

  • Syrentis Clinical Research

    Santa Ana, California, 92705

  • Intercoastal Medical Group

    Sarasota, Florida, 34239

  • University Washington MedCentre

    Seattle, Washington, 98104-2499

  • Schuster Med Research Institute

    Sherman Oaks, California, 91403

  • The Cognitive Research Center of New Jersey

    Springfield, New Jersey, 07081

  • Oregon Neurology Associates

    Springfield, Oregon, 97477

  • Barnes-Jewish Hospital IDS

    St Louis, Missouri, 63110

  • Richmond Behavioral Associates

    Staten Island, New York, 10312

  • Banner Sun Health Research Institute

    Sun City, Arizona, 85351

  • Stedman Clinical Trials, LLC

    Tampa, Florida, 33613

  • Meridien Research

    Tampa, Florida, 33634

  • Synexus The Villages

    The Villages, Florida, 32162

  • Advanced Memory Research Institute of NJ, PC

    Toms River, New Jersey, 08755

  • Banner Alzheimer's Institute

    Tucson, Arizona, 85718

  • Advanced Clinical Research

    West Jordan, Utah, 84088

  • Columbus Neuroscience, LLC

    Westerville, Ohio, 43082

  • Alliance Multispecialty Research

    Wichita, Kansas, 67207

Other trials in United States

China44 sites

  • Peking Union Hospital

    Beijing, Beijing Municipality, 100032

  • Peking University 1st Hospital

    Beijing, Beijing Municipality, 100034

  • Xuanwu Hospital

    Beijing, Beijing Municipality, 100053

  • Beijing Tiantan Hospital

    Beijing, Beijing Municipality, 100070

  • Beijing Anding Hospital

    Beijing, Beijing Municipality, 100088

  • Beijing Hospital

    Beijing, Beijing Municipality, 100730

  • Beijing Tong Ren Hospital

    Beijing, Beijing Municipality, 100730

  • 1st Hospital Jilin University

    Changchun, Jilin, 130021

  • Xiangya Hospital

    Changsha, Hunan, 410008

  • West China Hospital

    Chengdu, Sichuan, 610041

  • 1st Hospital of Chongqing MU

    Chongqing, Chongqing Municipality, 400016

  • Fujian Union Hospital

    Fuzhou, Fujian, 350001

  • 1st Hospital of Fujian MU

    Fuzhou, Fujian, 350005

  • 1st Hospital of Guangzhou MU

    Guangzhou, Guangdong, 510120

  • Guangzhou 1st People's Hospital

    Guangzhou, Guangdong, 510180

  • 2nd Hospital of Guangzhou MU

    Guangzhou, Guangdong, 510260

  • 2nd Hospital Zhongshan University

    Guangzhou, Guangdong, 510260

  • Zhejiang Provincial Hospital

    Hangzhou, Zhejiang, 310000

  • 1st Hospital Zhejiang University

    Hangzhou, Zhejiang, 310003

  • 1st Hospital of Anhui MU

    Hefei, Anhui, 230022

  • Qilu Hospital

    Jinan, Shandong, 250012

  • Shandong Provincial Hospital

    Jinan, Shandong, 250021

  • 1st Hospital of Kunming MU

    Kunming, Yunnan, 650032

  • Jiangxi Provincial Hospital

    Nanchang, Jiangxi, 330006

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu, 210000

  • Zhong Da Hospital

    Nanjing, Jiangsu, 210009

  • Qingdao Municipal Hospital

    Qingdao, Shandong, 266071

  • Ruijin Hospital

    Shanghai, Shanghai Municipality, 200020

  • Shanghai Mental Health Center

    Shanghai, Shanghai Municipality, 200030

  • Huashan Hospital; Fudan U

    Shanghai, Shanghai Municipality, 200040

  • Shanghai General Hospital

    Shanghai, Shanghai Municipality, 200080

  • Kangning Hospital of Shenzhen

    Shenzhen, Guangdong, 518118

  • 1st Hospital of Hebei MU

    Shijiazhuang, Hebei, 50030

  • 2nd Hospital Soochow University

    Suzhou, Jiangsu, 215004

  • 1st Hospital of Shanxi MU

    Taiyuan, Shanxi, 30001

  • Tangshan Gongren Hospital

    Tangshan, Hebei, 63000

  • Tianjin MU General Hospital

    Tianjin, Tianjin Municipality, 300052

  • Tianjin Huanhu Hospital

    Tianjin, Tianjin Municipality, 300060

  • 1st Hospital of Wenzhou MU

    Wenzhou, Zhejiang, 325000

  • Tang Du Hospital

    Xi'an, Shaanxi, 710038

  • Xi'an Mental Health Cente

    Xi'an, Shaanxi, 710061

  • Zhongshan Hospital Xiamen U

    Xiamen, Fujian, 361004

  • General Hospital of Ningxia MU

    Yinchuan, Ningxia, 750004

  • Yueyang 1st People's Hospital

    Yueyang, Hunan, 414000

Other trials in China

Canada17 sites

  • Heritage Medical Research Clinic

    Calgary, Alberta, T2N 4Z6

  • Clinique Memoire Outaouais

    Gatineau, Quebec, J8T 8J1

  • True North Clinical Research Inc

    Halifax, Nova Scotia, B3M 1N2

  • The Medical Arts Health Research Group

    Kamloops, British Columbia, V2C 5T1

  • Okanagan Clinical Trials

    Kelowna, British Columbia, V1Y 1Z9

  • MedicalArtsHealth Research Grp

    Kelowna, British Columbia, V1Y 4N7

  • True North Clinical Research

    New Minas, Nova Scotia, B4N 3R7

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

    Ottawa, Ontario, K1Z 1G3

  • MedicalArtsHealth Research Grp

    Penticton, British Columbia, V2A 5L5

  • ALPHA Recherche Clinique

    Québec, Qc G3K 2P8

  • Q & T Research Sherbrooke Inc

    Sherbrooke, Quebec, J1J 2G2

  • Diex Recherche Sherbrooke

    Sherbrooke, Quebec, J1L0H8

  • Toronto Memory Program

    Toronto, Ontario, M3B 2S7

  • Toronto Western Hospital

    Toronto, Ontario, M5T 2S8

  • Douglas Hospital Research Centre

    Verdun, Quebec, H4H 1R3

  • Vancouver Island Health Authority

    Victoria, British Columbia, V8R1J8

  • Medical Arts Health Research Grp

    West Vancouver, British Columbia, V7T 1C5

Other trials in Canada

France14 sites

  • Groupe Hospitalier Pellegrin

    Bordeaux, Gironde, 33076

  • Neurologique Pierre Wertheimer

    Bron, Rhone, 69677

  • Hopitaux Civils de Colmar

    Colmar, Grand Est, 68024

  • Centre Memoire Ressources

    Dijon, De Lattre de Tassigny, 21000

  • CHUTimone Adultes Service

    Marseille, Bouches-du-Rhône, 13005

  • HOPITAL Gui de CHAULIAC

    Montpellier, Cedex 5, 34295

  • CHU Nantes-Hopital Nord Laennec

    Nantes, Loire Atlantique, 44093

  • CMRR Paris Nord

    Paris, 75010

  • CHU Reims-Hopital Maison Blanche

    Reims, Marne, 51092

  • Pharmacie CHU de Rennes

    Rennes, Ille Et Vilaine, 35033

  • Centred Investigation Clinique

    Strasbourg, Bas Rhin, 67098

  • CHU Tours-Hopital Bretonneau

    Tonnerre, Indre Et Loire, 37044

  • Recherche Clinique Gerontopole

    Toulouse, Haute Garonne, 31059

  • Hopital des Charpennes

    Villeurbanne, Rhone, 69100

Other trials in France

Poland11 sites

  • Podlaskie Centrum Psychogeriatri

    Bialystok, 15-756

  • NZOZ Vitamed

    Bydgoszcz, 85-079

  • Wielospec. Poradnia Lekarska

    Katowice, 40-123

  • Nzoz Novo Med

    Katowice, 40-650

  • Specjalistyczne Gabinety Sp.zo.o

    Krakow, 30-539

  • NZOZ Neuromed MiMNastajSpp

    Lublin, 20-064

  • Medicome Sp z o o

    Oświęcim, 32-600

  • Solumed Centrum Medyczne

    Poznan, 60-529

  • Neuro Protect

    Warsaw, 01-684

  • Wrclawskie Cntrm Alzheimerowskie

    Wroclaw, 53659

  • Wielospecjalistyczne Centrm Med

    Zabrze, 41-800

Other trials in Poland

Czechia6 sites

  • NeuropsychiatrieHK s.r.o.

    Hradec Králové, 50341

  • BRAIN-SOULTHERAPY s.r.o.

    Kladno, 27204

  • Neuroterapie KH s.r.o.

    Kutná Hora, 28401

  • Clintrial s.r.o.

    Prague, 10100

  • FORBELI s.r.o.

    Prague, 16000

  • Neuropsychiatrie s.r.o.

    Prague, 16100

Other trials in Czechia

Australia4 sites

  • Hornsby Ku-ring-gai Hospital

    Hornsby, New South Wales, 2077

  • KaRa MINDS

    Macquarie Park, New South Wales, 2113

  • Austin Health - Heidelberg Repatriation Hospital

    Melbourne, Victoria, 3081

  • Alzheimer's Research Foundation

    Nedlands, Western Australia, 6009

Other trials in Australia

Netherlands4 sites

  • Pharmacy Jeroen Bosch Ziekenhuis

    's-Hertogenbosch, 5223 LA

  • VUmc Goederenontvangst

    Amsterdam, Van Der Boechorststraat 6, 1081 GN

  • Amphia Hospital Breda

    Breda, 4818 C.K

  • Klinische Farmacie

    Zwolle, 8025 AB

Other trials in Netherlands

Taiwan3 sites

  • National Taiwan UniversityHosp

    Taipei, 10048

  • Tri Service General Hospital

    Taipei, 11490

  • Chang GungMemorial Hosp Linkou

    Taoyuan, 333

Other trials in Taiwan

Hong Kong1 site

  • Prince of Wales Hospital

    Shatin

Other trials in Hong Kong

About this study

Official title: 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)

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

Being tested
GV-971, Placebo
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GV-971Drug

    Administered PO

  • PlaceboDrug

    Administered PO

Study groups in NCT04520412
Study groupRoleWhat they receive
GV-971ExperimentalNot described
Receives: Drug: GV-971
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in the ADAS-cog/11 score

    Change from baseline in Alzheimer's Disease Assessments Scale - cognitive (ADAS-cog/11) scale total score. The total score of ADAS-cog/11 is 0-70, with higher scores mean a worse outcome.

    Measured: Baseline, 48 weeks and 52 weeks

  2. Change from baseline in the ADCS-CGIC score

    Change from baseline on Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC) scale total score. The total score of ADCS-CGIC is 1-7, with higher scores mean a worse outcome.

    Measured: Baseline, 48 weeks and 52 weeks

Secondary outcomes (7)

  1. Change from baseline in NPI score

    Change from baseline in Neuropsychiatric Inventory (NPI) score. The total score of NPI is 0-144, with higher scores mean a worse outcome.

    Measured: Baseline, 36 Weeks, 52 Weeks

  2. Change from baseline in MMSE score

    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.

    Measured: Baseline, 52 Weeks

  3. Change from baseline in ADCS-ADL23 score

    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.

    Measured: Baseline, 36 Weeks, 52 Weeks

  4. Change from baseline in NPI caregiver items

    Change from baseline in Neuropsychiatric Inventory (NPI) caregiver items . The total score of NPI caregiver items is 0-60, with higher scores mean a worse outcome.

    Measured: Baseline, 52 Weeks

  5. Change from baseline in ZBI score

    Change from baseline in Zarit Burden Interview (ZBI) score. The total score of ZBI is 0-88, with higher scores mean a worse outcome.

    Measured: Baseline, 52 Weeks

  6. Assess the efficacy of GV-971 throughout the OLE period

    Change from baseline in Alzheimer's Disease Assessments Scale - cognitive (ADAS-cog/11) scale total score. The total score of ADAS-cog/11 is 0-70, with higher scores mean a worse outcome.

    Measured: Baseline, 52 Weeks, 78 Weeks

  7. Assess the efficacy of GV-971 throughout the OLE period

    Change from baseline on Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC) scale total score. The total score of ADCS-CGIC is 1-7, with higher scores mean a worse outcome.

    Measured: Baseline, 52 Weeks, 78 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2020
  2. Study start27 Oct 2020
  3. Primary completionDec 2025 (estimated)
  4. Study completionOct 2026 (estimated)

Why it stopped: 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.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
2,046 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04520412
Sponsor's protocol ID
GV971-007
Acronym
GREEN MEMORY
Status last verified
Nov 2022
First submitted
11 Aug 2020
Last updated
23 Nov 2022
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing GV-971 in people with Alzheimer Disease, run by Green Valley (Shanghai) Pharmaceuticals Co., Ltd. at 171 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: paused, as of the sponsor's last update on 23 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 171 sites in United States, China, Canada, France, Poland and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in the ADAS-cog/11 score (time frame: Baseline, 48 weeks and 52 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04520412.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2022.

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