Study 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.
A Study of Sodium Oligomannate (GV-971) in Participants With Mild to Moderate Alzheimer's Disease
GREEN MEMORY
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)
1 other identifier
interventional
2,046
10 countries
171
Brief Summary
The purpose of this study is to evaluate the safety, tolerability and efficacy of GV-971 in mild to moderate Alzheimer's disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 alzheimer-disease
Started Oct 2020
Longer than P75 for phase_3 alzheimer-disease
171 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 11, 2020
CompletedFirst Posted
Study publicly available on registry
August 20, 2020
CompletedStudy Start
First participant enrolled
October 27, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2026
ExpectedNovember 23, 2022
November 1, 2022
5.1 years
August 11, 2020
November 18, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
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.
Baseline, 48 weeks and 52 weeks
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.
Baseline, 48 weeks and 52 weeks
Secondary Outcomes (7)
Change from baseline in NPI score
Baseline, 36 Weeks, 52 Weeks
Change from baseline in MMSE score
Baseline, 52 Weeks
Change from baseline in ADCS-ADL23 score
Baseline, 36 Weeks, 52 Weeks
Change from baseline in NPI caregiver items
Baseline, 52 Weeks
Change from baseline in ZBI score
Baseline, 52 Weeks
- +2 more secondary outcomes
Other Outcomes (2)
Evaluate the population PK
Baseline, 12 Weeks, 24 Weeks, 52 Weeks
Evaluate the effect of GV-971 on brain structure neurodegeneration
Baseline, 52 Weeks
Study Arms (2)
GV-971
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (171)
Cognitive Clinical Trials, LLC
Gilbert, Arizona, 85297, United States
Banner Alzheimer's Institute
Phoenix, Arizona, 85006, United States
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013, United States
Banner Sun Health Research Institute
Sun City, Arizona, 85351, United States
Banner Alzheimer's Institute
Tucson, Arizona, 85718, United States
Irvine Clinical Research
Irvine, California, 92614, United States
Sunwise Clinical Research
Lafayette, California, 94549, United States
Pharmacology Research Institute
Los Alamitos, California, 90720, United States
Pacific Research Network, Inc
San Diego, California, 92103, United States
Pacific Research Network
San Diego, California, 92103, United States
Syrentis Clinical Research
Santa Ana, California, 92705, United States
Schuster Med Research Institute
Sherman Oaks, California, 91403, United States
JEM Research LLC
Atlantis, Florida, 33462, United States
Brain Matters Research
Delray Beach, Florida, 33445, United States
Finlay Medical Research Corp
Greenacres City, Florida, 33467, United States
Velocity Clinical Research
Hallandale, Florida, 33009, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216, United States
Charter Research, LLC
Lady Lake, Florida, 32159, United States
Innovative Clinical Research, Inc.
Lauderhill, Florida, 33319, United States
ClinCloud, LLC
Maitland, Florida, 32751, United States
Merritt Island Medical Research, LLC
Merritt Island, Florida, 32952, United States
Collier Neurologic Specialists
Naples, Florida, 34105, United States
Suncoast Clinical Research Inc.
New Port Richey, Florida, 34652, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32801, United States
Synexus Clinical Research
Orlando, Florida, 32806, United States
Neurology Associates of Ormond Beach
Ormond Beach, Florida, 32174, United States
Quantum Lab CNS Clinical Research
Pompano Beach, Florida, 33064, United States
Progressive Medical Research
Port Orange, Florida, 32127, United States
Intercoastal Medical Group
Sarasota, Florida, 34239, United States
Stedman Clinical Trials, LLC
Tampa, Florida, 33613, United States
Meridien Research
Tampa, Florida, 33634, United States
Synexus The Villages
The Villages, Florida, 32162, United States
NeuroStudies.net, LLC
Decatur, Georgia, 30033, United States
Great Lakes Clinical Trials
Chicago, Illinois, 60640, United States
Indiana University
Indianapolis, Indiana, 46202, United States
Alliance Multispecialty Research
Wichita, Kansas, 67207, United States
Activmed Practices&Research
Lawrence, Massachusetts, 01843, United States
Quest Research Institute
Farmington Hills, Michigan, 48334, United States
Barnes-Jewish Hospital IDS
St Louis, Missouri, 63110, United States
University of Nebraska Medical Center-Hematology/Oncology Section
Omaha, Nebraska, 68106, United States
Cognitive Clinical Trials, LLC
Omaha, Nebraska, 68130, United States
Altea Research Institute, Las Vegas
Las Vegas, Nevada, 89102, United States
Global Medical Institutes, LLC
Princeton, New Jersey, 08540, United States
The Cognitive Research Center of New Jersey
Springfield, New Jersey, 07081, United States
Advanced Memory Research Institute of NJ, PC
Toms River, New Jersey, 08755, United States
Integrative Clinical Trials LLC
Brooklyn, New York, 11229, United States
UBMD Neurology
Buffalo, New York, 14203, United States
Clarity Clinical Research
East Syracuse, New York, 13057, United States
Richmond Behavioral Associates
Staten Island, New York, 10312, United States
Behavioral Health Research Center
Charlotte, North Carolina, 28211, United States
AMC Research, LLC
Charlotte, North Carolina, 28270, United States
Guilford Neurologic Associate
Greensboro, North Carolina, 27405, United States
Insight Clinical Trials LLC
Beachwood, Ohio, 44122, United States
New Horizons Clinical Research
Cincinnati, Ohio, 45040, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Columbus Neuroscience, LLC
Westerville, Ohio, 43082, United States
Summit Research Network(Oregon)Inc.
Portland, Oregon, 97210, United States
Oregon Health&Science Universty
Portland, Oregon, 97239, United States
Oregon Neurology Associates
Springfield, Oregon, 97477, United States
Abington Neurological Associates, LTD
Abington, Pennsylvania, 19001, United States
SCarolina Institute Brain Health
Charleston, South Carolina, 29401, United States
Kerwin Research Center
Dallas, Texas, 75231, United States
Huston Methodist Hospital
Houston, Texas, 77030, United States
Clinical Trials of Texas; Inc
San Antonio, Texas, 78229, United States
Advanced Clinical Research
West Jordan, Utah, 84088, United States
Cognition Health
Fairfax, Virginia, 22031, United States
University Washington MedCentre
Seattle, Washington, 98104-2499, United States
Hornsby Ku-ring-gai Hospital
Hornsby, New South Wales, 2077, Australia
KaRa MINDS
Macquarie Park, New South Wales, 2113, Australia
Austin Health - Heidelberg Repatriation Hospital
Melbourne, Victoria, 3081, Australia
Alzheimer's Research Foundation
Nedlands, Western Australia, 6009, Australia
Heritage Medical Research Clinic
Calgary, Alberta, T2N 4Z6, Canada
The Medical Arts Health Research Group
Kamloops, British Columbia, V2C 5T1, Canada
Okanagan Clinical Trials
Kelowna, British Columbia, V1Y 1Z9, Canada
MedicalArtsHealth Research Grp
Kelowna, British Columbia, V1Y 4N7, Canada
MedicalArtsHealth Research Grp
Penticton, British Columbia, V2A 5L5, Canada
Vancouver Island Health Authority
Victoria, British Columbia, V8R1J8, Canada
Medical Arts Health Research Grp
West Vancouver, British Columbia, V7T 1C5, Canada
True North Clinical Research Inc
Halifax, Nova Scotia, B3M 1N2, Canada
True North Clinical Research
New Minas, Nova Scotia, B4N 3R7, Canada
Recherches Neuro-Hippocampe Inc., d/b/a Ottawa Memory Clinic
Ottawa, Ontario, K1Z 1G3, Canada
Toronto Memory Program
Toronto, Ontario, M3B 2S7, Canada
Toronto Western Hospital
Toronto, Ontario, M5T 2S8, Canada
Clinique Memoire Outaouais
Gatineau, Quebec, J8T 8J1, Canada
Q & T Research Sherbrooke Inc
Sherbrooke, Quebec, J1J 2G2, Canada
Diex Recherche Sherbrooke
Sherbrooke, Quebec, J1L0H8, Canada
Douglas Hospital Research Centre
Verdun, Quebec, H4H 1R3, Canada
ALPHA Recherche Clinique
Québec, Qc G3K 2P8, Canada
1st Hospital of Anhui MU
Hefei, Anhui, 230022, China
Peking Union Hospital
Beijing, Beijing Municipality, 100032, China
Peking University 1st Hospital
Beijing, Beijing Municipality, 100034, China
Xuanwu Hospital
Beijing, Beijing Municipality, 100053, China
Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100070, China
Beijing Anding Hospital
Beijing, Beijing Municipality, 100088, China
Beijing Hospital
Beijing, Beijing Municipality, 100730, China
Beijing Tong Ren Hospital
Beijing, Beijing Municipality, 100730, China
1st Hospital of Chongqing MU
Chongqing, Chongqing Municipality, 400016, China
Fujian Union Hospital
Fuzhou, Fujian, 350001, China
1st Hospital of Fujian MU
Fuzhou, Fujian, 350005, China
Zhongshan Hospital Xiamen U
Xiamen, Fujian, 361004, China
1st Hospital of Guangzhou MU
Guangzhou, Guangdong, 510120, China
Guangzhou 1st People's Hospital
Guangzhou, Guangdong, 510180, China
2nd Hospital of Guangzhou MU
Guangzhou, Guangdong, 510260, China
2nd Hospital Zhongshan University
Guangzhou, Guangdong, 510260, China
Kangning Hospital of Shenzhen
Shenzhen, Guangdong, 518118, China
1st Hospital of Hebei MU
Shijiazhuang, Hebei, 50030, China
Tangshan Gongren Hospital
Tangshan, Hebei, 63000, China
Xiangya Hospital
Changsha, Hunan, 410008, China
Yueyang 1st People's Hospital
Yueyang, Hunan, 414000, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210000, China
Zhong Da Hospital
Nanjing, Jiangsu, 210009, China
2nd Hospital Soochow University
Suzhou, Jiangsu, 215004, China
Jiangxi Provincial Hospital
Nanchang, Jiangxi, 330006, China
1st Hospital Jilin University
Changchun, Jilin, 130021, China
General Hospital of Ningxia MU
Yinchuan, Ningxia, 750004, China
Tang Du Hospital
Xi'an, Shaanxi, 710038, China
Xi'an Mental Health Cente
Xi'an, Shaanxi, 710061, China
Qilu Hospital
Jinan, Shandong, 250012, China
Shandong Provincial Hospital
Jinan, Shandong, 250021, China
Qingdao Municipal Hospital
Qingdao, Shandong, 266071, China
Ruijin Hospital
Shanghai, Shanghai Municipality, 200020, China
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030, China
Huashan Hospital; Fudan U
Shanghai, Shanghai Municipality, 200040, China
Shanghai General Hospital
Shanghai, Shanghai Municipality, 200080, China
1st Hospital of Shanxi MU
Taiyuan, Shanxi, 30001, China
West China Hospital
Chengdu, Sichuan, 610041, China
Tianjin MU General Hospital
Tianjin, Tianjin Municipality, 300052, China
Tianjin Huanhu Hospital
Tianjin, Tianjin Municipality, 300060, China
1st Hospital of Kunming MU
Kunming, Yunnan, 650032, China
Zhejiang Provincial Hospital
Hangzhou, Zhejiang, 310000, China
1st Hospital Zhejiang University
Hangzhou, Zhejiang, 310003, China
1st Hospital of Wenzhou MU
Wenzhou, Zhejiang, 325000, China
NeuropsychiatrieHK s.r.o.
Hradec Králové, 50341, Czechia
BRAIN-SOULTHERAPY s.r.o.
Kladno, 27204, Czechia
Neuroterapie KH s.r.o.
Kutná Hora, 28401, Czechia
Clintrial s.r.o.
Prague, 10100, Czechia
FORBELI s.r.o.
Prague, 16000, Czechia
Neuropsychiatrie s.r.o.
Prague, 16100, Czechia
Centred Investigation Clinique
Strasbourg, Bas Rhin, 67098, France
CHUTimone Adultes Service
Marseille, Bouches-du-Rhône, 13005, France
HOPITAL Gui de CHAULIAC
Montpellier, Cedex 5, 34295, France
Centre Memoire Ressources
Dijon, De Lattre de Tassigny, 21000, France
Groupe Hospitalier Pellegrin
Bordeaux, Gironde, 33076, France
Hopitaux Civils de Colmar
Colmar, Grand Est, 68024, France
Recherche Clinique Gerontopole
Toulouse, Haute Garonne, 31059, France
Pharmacie CHU de Rennes
Rennes, Ille Et Vilaine, 35033, France
CHU Tours-Hopital Bretonneau
Tonnerre, Indre Et Loire, 37044, France
CHU Nantes-Hopital Nord Laennec
Nantes, Loire Atlantique, 44093, France
CHU Reims-Hopital Maison Blanche
Reims, Marne, 51092, France
Neurologique Pierre Wertheimer
Bron, Rhone, 69677, France
Hopital des Charpennes
Villeurbanne, Rhone, 69100, France
CMRR Paris Nord
Paris, 75010, France
Prince of Wales Hospital
Shatin, Hong Kong
VUmc Goederenontvangst
Amsterdam, Van Der Boechorststraat 6, 1081 GN, Netherlands
Pharmacy Jeroen Bosch Ziekenhuis
's-Hertogenbosch, 5223 LA, Netherlands
Amphia Hospital Breda
Breda, 4818 C.K, Netherlands
Klinische Farmacie
Zwolle, 8025 AB, Netherlands
Podlaskie Centrum Psychogeriatri
Bialystok, 15-756, Poland
NZOZ Vitamed
Bydgoszcz, 85-079, Poland
Wielospec. Poradnia Lekarska
Katowice, 40-123, Poland
Nzoz Novo Med
Katowice, 40-650, Poland
Specjalistyczne Gabinety Sp.zo.o
Krakow, 30-539, Poland
NZOZ Neuromed MiMNastajSpp
Lublin, 20-064, Poland
Medicome Sp z o o
Oświęcim, 32-600, Poland
Solumed Centrum Medyczne
Poznan, 60-529, Poland
Neuro Protect
Warsaw, 01-684, Poland
Wrclawskie Cntrm Alzheimerowskie
Wroclaw, 53659, Poland
Wielospecjalistyczne Centrm Med
Zabrze, 41-800, Poland
National Taiwan UniversityHosp
Taipei, 10048, Taiwan
Tri Service General Hospital
Taipei, 11490, Taiwan
Chang GungMemorial Hosp Linkou
Taoyuan District, 333, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director, Ph D
Green Valley (Shanghai) Pharmaceuticals Co., Ltd.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 11, 2020
First Posted
August 20, 2020
Study Start
October 27, 2020
Primary Completion
December 1, 2025
Study Completion (Estimated)
October 1, 2026
Last Updated
November 23, 2022
Record last verified: 2022-11