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

November 18, 2022 updated by: Green Valley (Shanghai) Pharmaceuticals Co., Ltd.

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

2046

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Hornsby, New South Wales, Australia, 2077
        • Hornsby Ku-Ring-Gai Hospital
      • Macquarie Park, New South Wales, Australia, 2113
        • KaRa MINDS
    • Victoria
      • Melbourne, Victoria, Australia, 3081
        • Austin Health - Heidelberg Repatriation Hospital
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Alzheimer's Research Foundation
  • Canada
      • Quebec, Canada, Qc G3K 2P8
        • Alpha Recherche Clinique
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • Heritage Medical Research Clinic
    • British Columbia
      • Kamloops, British Columbia, Canada, V2C 5T1
        • The Medical Arts Health Research Group
      • Kelowna, British Columbia, Canada, V1Y 1Z9
        • Okanagan Clinical Trials
      • Kelowna, British Columbia, Canada, V1Y 4N7
        • MedicalArtsHealth Research Grp
      • Penticton, British Columbia, Canada, V2A 5L5
        • MedicalArtsHealth Research Grp
      • Victoria, British Columbia, Canada, V8R1J8
        • Vancouver Island Health Authority
      • West Vancouver, British Columbia, Canada, V7T 1C5
        • Medical Arts Health Research Grp
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3M 1N2
        • True North Clinical Research Inc
      • New Minas, Nova Scotia, Canada, B4N 3R7
        • True North Clinical Research
    • Ontario
      • Ottawa, Ontario, Canada, K1Z 1G3
        • Recherches Neuro-Hippocampe Inc., d/b/a Ottawa Memory Clinic
      • Toronto, Ontario, Canada, M5T 2S8
        • Toronto Western Hospital
      • Toronto, Ontario, Canada, M3B 2S7
        • Toronto Memory Program
    • Quebec
      • Gatineau, Quebec, Canada, J8T 8J1
        • Clinique Memoire Outaouais
      • Sherbrooke, Quebec, Canada, J1J 2G2
        • Q & T Research Sherbrooke Inc
      • Sherbrooke, Quebec, Canada, J1L0H8
        • Diex Recherche Sherbrooke
      • Verdun, Quebec, Canada, H4H 1R3
        • Douglas Hospital Research Centre
  • China
    • Anhui
      • Hefei, Anhui, China, 230022
        • 1st Hospital of Anhui MU
    • Beijing
      • Beijing, Beijing, China, 100070
        • Beijing Tiantan Hospital
      • Beijing, Beijing, China, 100730
        • Beijing Hospital
      • Beijing, Beijing, China, 100088
        • Beijing Anding Hospital
      • Beijing, Beijing, China, 100032
        • Peking Union Hospital
      • Beijing, Beijing, China, 100034
        • Peking University 1st Hospital
      • Beijing, Beijing, China, 100053
        • Xuanwu Hospital
      • Beijing, Beijing, China, 100730
        • Beijing Tong Ren Hospital
    • Chongqing
      • Chongqing, Chongqing, China, 400016
        • 1st Hospital of Chongqing MU
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Fujian Union Hospital
      • Fuzhou, Fujian, China, 350005
        • 1st Hospital of Fujian MU
      • Xiamen, Fujian, China, 361004
        • Zhongshan Hospital Xiamen U
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • 1st Hospital of Guangzhou MU
      • Guangzhou, Guangdong, China, 510180
        • Guangzhou 1st People's Hospital
      • Guangzhou, Guangdong, China, 510260
        • 2nd Hospital of Guangzhou MU
      • Guangzhou, Guangdong, China, 510260
        • 2nd Hospital Zhongshan University
      • Shenzhen, Guangdong, China, 518118
        • Kangning Hospital of Shenzhen
    • Hebei
      • Shijiazhuang, Hebei, China, 50030
        • 1st Hospital of Hebei MU
      • Tangshan, Hebei, China, 63000
        • Tangshan Gongren Hospital
    • Hunan
      • Changsha, Hunan, China, 410008
        • XiangYa Hospital
      • Yueyang, Hunan, China, 414000
        • Yueyang 1st People's Hospital
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Nanjing Drum Tower Hospital
      • Nanjing, Jiangsu, China, 210009
        • Zhong Da Hospital
      • Suzhou, Jiangsu, China, 215004
        • 2nd Hospital Soochow University
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Jiangxi Provincial Hospital
    • Jilin
      • Changchun, Jilin, China, 130021
        • 1st Hospital Jilin University
    • Ningxia Hui Autonomous Region
      • Yinchuan, Ningxia Hui Autonomous Region, China, 750004
        • General Hospital of Ningxia MU
    • Shaanxi
      • Xi'an, Shaanxi, China, 710038
        • Tang Du Hospital
      • Xi'an, Shaanxi, China, 710061
        • Xi'an Mental Health Cente
    • Shandong
      • Jinan, Shandong, China, 250021
        • Shandong Provincial Hospital
      • Jinan, Shandong, China, 250012
        • Qilu hospital
      • Qingdao, Shandong, China, 266071
        • Qingdao Municipal Hospital
    • Shanghai
      • Shanghai, Shanghai, China, 200080
        • Shanghai General Hospital
      • Shanghai, Shanghai, China, 200030
        • Shanghai Mental Health Center
      • Shanghai, Shanghai, China, 200020
        • Ruijin Hospital
      • Shanghai, Shanghai, China, 200040
        • Huashan Hospital; Fudan U
    • Shanxi
      • Taiyuan, Shanxi, China, 30001
        • 1st Hospital of Shanxi MU
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Hospital
    • Tianjin
      • Tianjin, Tianjin, China, 300052
        • Tianjin MU General Hospital
      • Tianjin, Tianjin, China, 300060
        • Tianjin Huanhu Hospital
    • Yunnan
      • Kunming, Yunnan, China, 650032
        • 1st Hospital of Kunming MU
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Zhejiang Provincial Hospital
      • Hangzhou, Zhejiang, China, 310003
        • 1st Hospital Zhejiang University
      • Wenzhou, Zhejiang, China, 325000
        • 1st Hospital of Wenzhou MU
  • Czechia
      • Hradec Králové, Czechia, 50341
        • NeuropsychiatrieHK s.r.o.
      • Kladno, Czechia, 27204
        • BRAIN-SOULTHERAPY s.r.o.
      • Kutná Hora, Czechia, 28401
        • Neuroterapie KH s.r.o.
      • Praha, Czechia, 16000
        • FORBELI s.r.o.
      • Praha, Czechia, 16100
        • Neuropsychiatrie s.r.o.
      • Praha 10, Czechia, 10100
        • Clintrial s.r.o.
  • France
      • Paris, France, 75010
        • CMRR Paris Nord
    • Bas Rhin
      • Strasbourg, Bas Rhin, France, 67098
        • Centred Investigation Clinique
    • Bouches-du-Rhône
      • Marseille, Bouches-du-Rhône, France, 13005
        • CHUTimone Adultes Service
    • Cedex 5
      • Montpellier, Cedex 5, France, 34295
        • Hopital Gui de Chauliac
    • De Lattre De Tassigny
      • Dijon, De Lattre De Tassigny, France, 21000
        • Centre Memoire Ressources
    • Gironde
      • Bordeaux, Gironde, France, 33076
        • Groupe Hospitalier Pellegrin
    • Grand Est
      • Colmar, Grand Est, France, 68024
        • Hôpitaux Civils de Colmar
    • Haute Garonne
      • Toulouse, Haute Garonne, France, 31059
        • Recherche Clinique Gerontopole
    • Ille Et Vilaine
      • Rennes, Ille Et Vilaine, France, 35033
        • Pharmacie CHU de Rennes
    • Indre Et Loire
      • Tonnerre, Indre Et Loire, France, 37044
        • CHU tours-Hopital Bretonneau
    • Loire Atlantique
      • Nantes, Loire Atlantique, France, 44093
        • Chu Nantes-Hopital Nord Laennec
    • Marne
      • Reims, Marne, France, 51092
        • CHU Reims-Hôpital Maison Blanche
    • Rhone
      • Bron, Rhone, France, 69677
        • Neurologique Pierre Wertheimer
      • Villeurbanne, Rhone, France, 69100
        • Hôpital des Charpennes
  • Hong Kong
      • Shatin, Hong Kong
        • Prince of Wales Hospital
  • Netherlands
      • Breda, Netherlands, 4818 C.K
        • Amphia hospital Breda
      • Herzogenbusch, Netherlands, 5223 LA
        • Pharmacy Jeroen Bosch Ziekenhuis
      • Zwolle, Netherlands, 8025 AB
        • Klinische Farmacie
    • Van Der Boechorststraat 6
      • Amsterdam, Van Der Boechorststraat 6, Netherlands, 1081 GN
        • VUMC Goederenontvangst
  • Poland
      • Bialystok, Poland, 15-756
        • Podlaskie Centrum Psychogeriatri
      • Bydgoszcz, Poland, 85-079
        • NZOZ Vitamed
      • Katowice, Poland, 40-650
        • NZOZ Novo Med
      • Katowice, Poland, 40-123
        • Wielospec. Poradnia Lekarska
      • Kraków, Poland, 30-539
        • Specjalistyczne Gabinety Sp.zo.o
      • Lublin, Poland, 20-064
        • NZOZ Neuromed MiMNastajSpp
      • Oświęcim, Poland, 32-600
        • Medicome Sp z o o
      • Poznań, Poland, 60-529
        • Solumed Centrum Medyczne
      • Warszawa, Poland, 01-684
        • Neuro Protect
      • Wrocław, Poland, 53659
        • Wrclawskie Cntrm Alzheimerowskie
      • Zabrze, Poland, 41-800
        • Wielospecjalistyczne Centrm Med
  • Taiwan
      • Taipei, Taiwan, 10048
        • National Taiwan UniversityHosp
      • Taipei, Taiwan, 11490
        • Tri Service General Hospital
      • Taoyuan, Taiwan, 333
        • Chang GungMemorial Hosp Linkou
  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85297
        • Cognitive Clinical Trials, LLC
      • Phoenix, Arizona, United States, 85006
        • Banner Alzheimer's Institute
      • Phoenix, Arizona, United States, 85013
        • St. Joseph's Hospital and Medical Center
      • Sun City, Arizona, United States, 85351
        • Banner Sun Health Research Institute
      • Tucson, Arizona, United States, 85718
        • Banner Alzheimer's Institute
    • California
      • Irvine, California, United States, 92614
        • Irvine Clinical Research
      • Lafayette, California, United States, 94549
        • Sunwise Clinical Research
      • Los Alamitos, California, United States, 90720
        • Pharmacology Research Institute
      • San Diego, California, United States, 92103
        • Pacific Research Network
      • San Diego, California, United States, 92103
        • Pacific Research Network, Inc
      • Santa Ana, California, United States, 92705
        • Syrentis Clinical Research
      • Sherman Oaks, California, United States, 91403
        • Schuster Med Research Institute
    • Florida
      • Atlantis, Florida, United States, 33462
        • JEM Research LLC
      • Delray Beach, Florida, United States, 33445
        • Brain Matters Research
      • Greenacres City, Florida, United States, 33467
        • Finlay Medical Research Corp
      • Hallandale Beach, Florida, United States, 33009
        • Velocity Clinical Research
      • Jacksonville, Florida, United States, 32216
        • Jacksonville Center for Clinical Research
      • Lady Lake, Florida, United States, 32159
        • Charter Research, LLC
      • Lauderhill, Florida, United States, 33319
        • Innovative Clinical Research, Inc.
      • Maitland, Florida, United States, 32751
        • ClinCloud, LLC
      • Merritt Island, Florida, United States, 32952
        • Merritt Island Medical Research, LLC
      • Naples, Florida, United States, 34105
        • Collier Neurologic Specialists
      • New Port Richey, Florida, United States, 34652
        • Suncoast Clinical Research Inc.
      • Orlando, Florida, United States, 32801
        • Clinical Neuroscience Solutions, Inc.
      • Orlando, Florida, United States, 32806
        • Synexus Clinical Research
      • Ormond Beach, Florida, United States, 32174
        • Neurology Associates of Ormond Beach
      • Pompano Beach, Florida, United States, 33064
        • Quantum Lab CNS Clinical Research
      • Port Orange, Florida, United States, 32127
        • Progressive Medical Research
      • Sarasota, Florida, United States, 34239
        • Intercoastal Medical Group
      • Tampa, Florida, United States, 33613
        • Stedman Clinical Trials, LLC
      • Tampa, Florida, United States, 33634
        • Meridien Research
      • The Villages, Florida, United States, 32162
        • Synexus The Villages
    • Georgia
      • Decatur, Georgia, United States, 30033
        • NeuroStudies.net, LLC
    • Illinois
      • Chicago, Illinois, United States, 60640
        • Great Lakes Clinical Trials
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University
    • Kansas
      • Wichita, Kansas, United States, 67207
        • Alliance Multispecialty Research
    • Massachusetts
      • Lawrence, Massachusetts, United States, 01843
        • Activmed Practices&Research
    • Michigan
      • Farmington Hills, Michigan, United States, 48334
        • Quest Research Institute
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Barnes-Jewish Hospital IDS
    • Nebraska
      • Omaha, Nebraska, United States, 68106
        • University of Nebraska Medical Center-Hematology/Oncology Section
      • Omaha, Nebraska, United States, 68130
        • Cognitive Clinical Trials, LLC
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • Altea Research Institute, Las Vegas
    • New Jersey
      • Princeton, New Jersey, United States, 08540
        • Global Medical Institutes, LLC
      • Springfield, New Jersey, United States, 07081
        • The Cognitive Research Center of New Jersey
      • Toms River, New Jersey, United States, 08755
        • Advanced Memory Research Institute of NJ, PC
    • New York
      • Brooklyn, New York, United States, 11229
        • Integrative Clinical Trials LLC
      • Buffalo, New York, United States, 14203
        • UBMD Neurology
      • East Syracuse, New York, United States, 13057
        • Clarity Clinical Research
      • Staten Island, New York, United States, 10312
        • Richmond Behavioral Associates
    • North Carolina
      • Charlotte, North Carolina, United States, 28211
        • Behavioral Health Research Center
      • Charlotte, North Carolina, United States, 28270
        • AMC Research, LLC
      • Greensboro, North Carolina, United States, 27405
        • Guilford Neurologic Associate
    • Ohio
      • Beachwood, Ohio, United States, 44122
        • Insight Clinical Trials LLC
      • Cincinnati, Ohio, United States, 45040
        • New Horizons Clinical Research
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
      • Westerville, Ohio, United States, 43082
        • Columbus Neuroscience, LLC
    • Oregon
      • Portland, Oregon, United States, 97210
        • Summit Research Network(Oregon)Inc.
      • Portland, Oregon, United States, 97239
        • Oregon Health&Science Universty
      • Springfield, Oregon, United States, 97477
        • Oregon Neurology Associates
    • Pennsylvania
      • Abington, Pennsylvania, United States, 19001
        • Abington Neurological Associates, LTD
    • South Carolina
      • Charleston, South Carolina, United States, 29401
        • SCarolina Institute Brain Health
    • Texas
      • Dallas, Texas, United States, 75231
        • Kerwin Research Center
      • Houston, Texas, United States, 77030
        • Huston Methodist Hospital
      • San Antonio, Texas, United States, 78229
        • Clinical Trials of Texas; Inc
    • Utah
      • West Jordan, Utah, United States, 84088
        • Advanced Clinical Research
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Cognition Health
    • Washington
      • Seattle, Washington, United States, 98104-2499
        • University Washington MedCentre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Administered PO
Experimental: GV-971
Drug: GV-971
Administered PO

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in the ADAS-cog/11 score
Time Frame: Baseline, 48 weeks and 52 weeks
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
Time Frame: Baseline, 48 weeks and 52 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in NPI score
Time Frame: Baseline, 36 Weeks, 52 Weeks
Change from baseline in Neuropsychiatric Inventory (NPI) score. The total score of NPI is 0-144, with higher scores mean a worse outcome.
Baseline, 36 Weeks, 52 Weeks
Change from baseline in MMSE score
Time Frame: Baseline, 52 Weeks
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.
Baseline, 52 Weeks
Change from baseline in ADCS-ADL23 score
Time Frame: Baseline, 36 Weeks, 52 Weeks
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.
Baseline, 36 Weeks, 52 Weeks
Change from baseline in NPI caregiver items
Time Frame: Baseline, 52 Weeks
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.
Baseline, 52 Weeks
Change from baseline in ZBI score
Time Frame: Baseline, 52 Weeks
Change from baseline in Zarit Burden Interview (ZBI) score. The total score of ZBI is 0-88, with higher scores mean a worse outcome.
Baseline, 52 Weeks
Assess the efficacy of GV-971 throughout the OLE period
Time Frame: Baseline, 52 Weeks, 78 Weeks
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, 52 Weeks, 78 Weeks
Assess the efficacy of GV-971 throughout the OLE period
Time Frame: Baseline, 52 Weeks, 78 Weeks
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, 52 Weeks, 78 Weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the population PK
Time Frame: Baseline, 12 Weeks, 24 Weeks, 52 Weeks
Determine serum levels of GV-971 in population PK
Baseline, 12 Weeks, 24 Weeks, 52 Weeks
Evaluate the effect of GV-971 on brain structure neurodegeneration
Time Frame: Baseline, 52 Weeks
Changes from baseline in volumetric magnetic resonance imaging (MRI)
Baseline, 52 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Green Valley (Shanghai) Pharmaceuticals Co., Ltd.

Investigators

  • Study Director: Study Director, Ph D, Green Valley (Shanghai) Pharmaceuticals Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 27, 2020

Primary Completion (Anticipated)

December 1, 2025

Study Completion (Anticipated)

October 1, 2026

Study Registration Dates

First Submitted

August 11, 2020

First Submitted That Met QC Criteria

August 18, 2020

First Posted (Actual)

August 20, 2020

Study Record Updates

Last Update Posted (Actual)

November 23, 2022

Last Update Submitted That Met QC Criteria

November 18, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GV971-007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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