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

Alzheimer Disease Clinical Trial

— GREEN MEMORY  

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)

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04520412
• Other study ID #: GV971-007
• Status: Suspended
• Phase: Phase 3
• Start date: October 27, 2020
• Est. completion date: October 2026

Study information

• Verified date: November 2022
• Source: Green Valley (Shanghai) Pharmaceuticals Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 2046
• Est. completion date: October 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Drug:
• GV-971
Administered PO
• Placebo
Administered PO

Locations

Country	Name	City	State
Australia	Hornsby Ku-ring-gai Hospital	Hornsby	New South Wales
Australia	KaRa MINDS	Macquarie Park	New South Wales
Australia	Austin Health - Heidelberg Repatriation Hospital	Melbourne	Victoria
Australia	Alzheimer's Research Foundation	Nedlands	Western Australia
Canada	Heritage Medical Research Clinic	Calgary	Alberta
Canada	Clinique Memoire Outaouais	Gatineau	Quebec
Canada	True North Clinical Research Inc	Halifax	Nova Scotia
Canada	The Medical Arts Health Research Group	Kamloops	British Columbia
Canada	MedicalArtsHealth Research Grp	Kelowna	British Columbia
Canada	Okanagan Clinical Trials	Kelowna	British Columbia
Canada	True North Clinical Research	New Minas	Nova Scotia
Canada	Recherches Neuro-Hippocampe Inc., d/b/a Ottawa Memory Clinic	Ottawa	Ontario
Canada	MedicalArtsHealth Research Grp	Penticton	British Columbia
Canada	ALPHA Recherche Clinique	Quebec
Canada	Diex Recherche Sherbrooke	Sherbrooke	Quebec
Canada	Q & T Research Sherbrooke Inc	Sherbrooke	Quebec
Canada	Toronto Memory Program	Toronto	Ontario
Canada	Toronto Western Hospital	Toronto	Ontario
Canada	Douglas Hospital Research Centre	Verdun	Quebec
Canada	Vancouver Island Health Authority	Victoria	British Columbia
Canada	Medical Arts Health Research Grp	West Vancouver	British Columbia
China	Beijing Anding Hospital	Beijing	Beijing
China	Beijing Hospital	Beijing	Beijing
China	Beijing Tiantan Hospital	Beijing	Beijing
China	Beijing Tong Ren Hospital	Beijing	Beijing
China	Peking Union Hospital	Beijing	Beijing
China	Peking University 1st Hospital	Beijing	Beijing
China	Xuanwu Hospital	Beijing	Beijing
China	1st Hospital Jilin University	Changchun	Jilin
China	Xiangya Hospital	Changsha	Hunan
China	West China Hospital	Chengdu	Sichuan
China	1st Hospital of Chongqing MU	Chongqing	Chongqing
China	1st Hospital of Fujian MU	Fuzhou	Fujian
China	Fujian Union Hospital	Fuzhou	Fujian
China	1st Hospital of Guangzhou MU	Guangzhou	Guangdong
China	2nd Hospital of Guangzhou MU	Guangzhou	Guangdong
China	2nd Hospital Zhongshan University	Guangzhou	Guangdong
China	Guangzhou 1st People's Hospital	Guangzhou	Guangdong
China	1st Hospital Zhejiang University	Hangzhou	Zhejiang
China	Zhejiang Provincial Hospital	Hangzhou	Zhejiang
China	1st Hospital of Anhui MU	Hefei	Anhui
China	Qilu Hospital	Jinan	Shandong
China	Shandong Provincial Hospital	Jinan	Shandong
China	1st Hospital of Kunming MU	Kunming	Yunnan
China	Jiangxi Provincial Hospital	Nanchang	Jiangxi
China	Nanjing Drum Tower Hospital	Nanjing	Jiangsu
China	Zhong Da Hospital	Nanjing	Jiangsu
China	Qingdao Municipal Hospital	Qingdao	Shandong
China	Huashan Hospital; Fudan U	Shanghai	Shanghai
China	Ruijin Hospital	Shanghai	Shanghai
China	Shanghai General Hospital	Shanghai	Shanghai
China	Shanghai Mental Health Center	Shanghai	Shanghai
China	Kangning Hospital of Shenzhen	Shenzhen	Guangdong
China	1st Hospital of Hebei MU	Shijiazhuang	Hebei
China	2nd Hospital Soochow University	Suzhou	Jiangsu
China	1st Hospital of Shanxi MU	Taiyuan	Shanxi
China	Tangshan Gongren Hospital	Tangshan	Hebei
China	Tianjin Huanhu Hospital	Tianjin	Tianjin
China	Tianjin MU General Hospital	Tianjin	Tianjin
China	1st Hospital of Wenzhou MU	Wenzhou	Zhejiang
China	Tang Du Hospital	Xi'an	Shaanxi
China	Xi'an Mental Health Cente	Xi'an	Shaanxi
China	Zhongshan Hospital Xiamen U	Xiamen	Fujian
China	General Hospital of Ningxia MU	Yinchuan	Ningxia Hui Autonomous Region
China	Yueyang 1st People's Hospital	Yueyang	Hunan
Czechia	NeuropsychiatrieHK s.r.o.	Hradec Králové
Czechia	BRAIN-SOULTHERAPY s.r.o.	Kladno
Czechia	Neuroterapie KH s.r.o.	Kutná Hora
Czechia	FORBELI s.r.o.	Praha
Czechia	Neuropsychiatrie s.r.o.	Praha
Czechia	Clintrial s.r.o.	Praha 10
France	Groupe Hospitalier Pellegrin	Bordeaux	Gironde
France	Neurologique Pierre Wertheimer	Bron	Rhone
France	Hopitaux Civils de Colmar	Colmar	Grand Est
France	Centre Memoire Ressources	Dijon	De Lattre De Tassigny
France	CHUTimone Adultes Service	Marseille	Bouches-du-Rhône
France	HOPITAL Gui de CHAULIAC	Montpellier	Cedex 5
France	CHU Nantes-Hopital Nord Laennec	Nantes	Loire Atlantique
France	CMRR Paris Nord	Paris
France	CHU Reims-Hopital Maison Blanche	Reims	Marne
France	Pharmacie CHU de Rennes	Rennes	Ille Et Vilaine
France	Centred Investigation Clinique	Strasbourg	Bas Rhin
France	CHU Tours-Hopital Bretonneau	Tonnerre	Indre Et Loire
France	Recherche Clinique Gerontopole	Toulouse	Haute Garonne
France	Hopital des Charpennes	Villeurbanne	Rhone
Hong Kong	Prince of Wales Hospital	Shatin
Netherlands	VUmc Goederenontvangst	Amsterdam	Van Der Boechorststraat 6
Netherlands	Amphia Hospital Breda	Breda
Netherlands	Pharmacy Jeroen Bosch Ziekenhuis	Herzogenbusch
Netherlands	Klinische Farmacie	Zwolle
Poland	Podlaskie Centrum Psychogeriatri	Bialystok
Poland	NZOZ Vitamed	Bydgoszcz
Poland	Nzoz Novo Med	Katowice
Poland	Wielospec. Poradnia Lekarska	Katowice
Poland	Specjalistyczne Gabinety Sp.zo.o	Kraków
Poland	NZOZ Neuromed MiMNastajSpp	Lublin
Poland	Medicome Sp z o o	Oswiecim
Poland	Solumed Centrum Medyczne	Poznan
Poland	Neuro Protect	Warszawa
Poland	Wrclawskie Cntrm Alzheimerowskie	Wroclaw
Poland	Wielospecjalistyczne Centrm Med	Zabrze
Taiwan	National Taiwan UniversityHosp	Taipei
Taiwan	Tri Service General Hospital	Taipei
Taiwan	Chang GungMemorial Hosp Linkou	Taoyuan
United States	Abington Neurological Associates, LTD	Abington	Pennsylvania
United States	JEM Research LLC	Atlantis	Florida
United States	Insight Clinical Trials LLC	Beachwood	Ohio
United States	Integrative Clinical Trials LLC	Brooklyn	New York
United States	UBMD Neurology	Buffalo	New York
United States	SCarolina Institute Brain Health	Charleston	South Carolina
United States	AMC Research, LLC	Charlotte	North Carolina
United States	Behavioral Health Research Center	Charlotte	North Carolina
United States	Great Lakes Clinical Trials	Chicago	Illinois
United States	New Horizons Clinical Research	Cincinnati	Ohio
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Kerwin Research Center	Dallas	Texas
United States	NeuroStudies.net, LLC	Decatur	Georgia
United States	Brain Matters Research	Delray Beach	Florida
United States	Clarity Clinical Research	East Syracuse	New York
United States	Cognition Health	Fairfax	Virginia
United States	Quest Research Institute	Farmington Hills	Michigan
United States	Cognitive Clinical Trials, LLC	Gilbert	Arizona
United States	Finlay Medical Research Corp	Greenacres City	Florida
United States	Guilford Neurologic Associate	Greensboro	North Carolina
United States	Velocity Clinical Research	Hallandale Beach	Florida
United States	Huston Methodist Hospital	Houston	Texas
United States	Indiana University	Indianapolis	Indiana
United States	Irvine Clinical Research	Irvine	California
United States	Jacksonville Center for Clinical Research	Jacksonville	Florida
United States	Charter Research, LLC	Lady Lake	Florida
United States	Sunwise Clinical Research	Lafayette	California
United States	Altea Research Institute, Las Vegas	Las Vegas	Nevada
United States	Innovative Clinical Research, Inc.	Lauderhill	Florida
United States	Activmed Practices&Research	Lawrence	Massachusetts
United States	Pharmacology Research Institute	Los Alamitos	California
United States	ClinCloud, LLC	Maitland	Florida
United States	Merritt Island Medical Research, LLC	Merritt Island	Florida
United States	Collier Neurologic Specialists	Naples	Florida
United States	Suncoast Clinical Research Inc.	New Port Richey	Florida
United States	Cognitive Clinical Trials, LLC	Omaha	Nebraska
United States	University of Nebraska Medical Center-Hematology/Oncology Section	Omaha	Nebraska
United States	Clinical Neuroscience Solutions, Inc.	Orlando	Florida
United States	Synexus Clinical Research	Orlando	Florida
United States	Neurology Associates of Ormond Beach	Ormond Beach	Florida
United States	Banner Alzheimer's Institute	Phoenix	Arizona
United States	St. Joseph's Hospital and Medical Center	Phoenix	Arizona
United States	Quantum Lab CNS Clinical Research	Pompano Beach	Florida
United States	Progressive Medical Research	Port Orange	Florida
United States	Oregon Health&Science Universty	Portland	Oregon
United States	Summit Research Network(Oregon)Inc.	Portland	Oregon
United States	Global Medical Institutes, LLC	Princeton	New Jersey
United States	Barnes-Jewish Hospital IDS	Saint Louis	Missouri
United States	Clinical Trials of Texas; Inc	San Antonio	Texas
United States	Pacific Research Network	San Diego	California
United States	Pacific Research Network, Inc	San Diego	California
United States	Syrentis Clinical Research	Santa Ana	California
United States	Intercoastal Medical Group	Sarasota	Florida
United States	University Washington MedCentre	Seattle	Washington
United States	Schuster Med Research Institute	Sherman Oaks	California
United States	Oregon Neurology Associates	Springfield	Oregon
United States	The Cognitive Research Center of New Jersey	Springfield	New Jersey
United States	Richmond Behavioral Associates	Staten Island	New York
United States	Banner Sun Health Research Institute	Sun City	Arizona
United States	Meridien Research	Tampa	Florida
United States	Stedman Clinical Trials, LLC	Tampa	Florida
United States	Synexus The Villages	The Villages	Florida
United States	Advanced Memory Research Institute of NJ, PC	Toms River	New Jersey
United States	Banner Alzheimer's Institute	Tucson	Arizona
United States	Advanced Clinical Research	West Jordan	Utah
United States	Columbus Neuroscience, LLC	Westerville	Ohio
United States	Alliance Multispecialty Research	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Green Valley (Shanghai) Pharmaceuticals Co., Ltd.

Countries where clinical trial is conducted

United States,  Australia,  Canada,  China,  Czechia,  France,  Hong Kong,  Netherlands,  Poland,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Evaluate the population PK	Determine serum levels of GV-971 in population PK	Baseline, 12 Weeks, 24 Weeks, 52 Weeks
Other	Evaluate the effect of GV-971 on brain structure neurodegeneration	Changes from baseline in volumetric magnetic resonance imaging (MRI)	Baseline, 52 Weeks
Primary	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
Primary	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	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.	Baseline, 36 Weeks, 52 Weeks
Secondary	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.	Baseline, 52 Weeks
Secondary	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.	Baseline, 36 Weeks, 52 Weeks
Secondary	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.	Baseline, 52 Weeks
Secondary	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.	Baseline, 52 Weeks
Secondary	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.	Baseline, 52 Weeks, 78 Weeks
Secondary	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.	Baseline, 52 Weeks, 78 Weeks