Clinical trial NCT04520412: A Study of Sodium Oligomannate (GV-971) in Participants With Mild to Moderate Alzheimer's Disease
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)
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE3
Conditions: Alzheimer Disease
Lead sponsor: Green Valley (Shanghai) Pharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-08-20
Enrollment: 2046
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in the ADAS-cog/11 score
timeFrame: Baseline, 48 weeks and 52 weeks
measure: Change from baseline in the ADCS-CGIC score
timeFrame: Baseline, 48 weeks and 52 weeks
Secondary outcomes:
measure: Change from baseline in NPI score
timeFrame: Baseline, 36 Weeks, 52 Weeks
measure: Change from baseline in MMSE score
timeFrame: Baseline, 52 Weeks
measure: Change from baseline in ADCS-ADL23 score
timeFrame: Baseline, 36 Weeks, 52 Weeks
measure: Change from baseline in NPI caregiver items
timeFrame: Baseline, 52 Weeks
measure: Change from baseline in ZBI score
timeFrame: Baseline, 52 Weeks
measure: Assess the efficacy of GV-971 throughout the OLE period
timeFrame: Baseline, 52 Weeks, 78 Weeks
measure: Assess the efficacy of GV-971 throughout the OLE period
timeFrame: Baseline, 52 Weeks, 78 Weeks
Other outcomes:
measure: Evaluate the population PK
timeFrame: Baseline, 12 Weeks, 24 Weeks, 52 Weeks
measure: Evaluate the effect of GV-971 on brain structure neurodegeneration
timeFrame: Baseline, 52 Weeks
Locations:
city: Gilbert
country: United States
facility: Cognitive Clinical Trials, LLC
state: Arizona
city: Phoenix
country: United States
facility: Banner Alzheimer's Institute
state: Arizona
city: Phoenix
country: United States
facility: St. Joseph's Hospital and Medical Center
state: Arizona
city: Sun City
country: United States
facility: Banner Sun Health Research Institute
state: Arizona
city: Tucson
country: United States
facility: Banner Alzheimer's Institute
state: Arizona
city: Irvine
country: United States
facility: Irvine Clinical Research
state: California
city: Lafayette
country: United States
facility: Sunwise Clinical Research
state: California
city: Los Alamitos
country: United States
facility: Pharmacology Research Institute
state: California
city: San Diego
country: United States
facility: Pacific Research Network, Inc
state: California
city: San Diego
country: United States
facility: Pacific Research Network
state: California
city: Santa Ana
country: United States
facility: Syrentis Clinical Research
state: California
city: Sherman Oaks
country: United States
facility: Schuster Med Research Institute
state: California
city: Atlantis
country: United States
facility: JEM Research LLC
state: Florida
city: Delray Beach
country: United States
facility: Brain Matters Research
state: Florida
city: Greenacres City
country: United States
facility: Finlay Medical Research Corp
state: Florida
city: Hallandale Beach
country: United States
facility: Velocity Clinical Research
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Lady Lake
country: United States
facility: Charter Research, LLC
state: Florida
city: Lauderhill
country: United States
facility: Innovative Clinical Research, Inc.
state: Florida
city: Maitland
country: United States
facility: ClinCloud, LLC
state: Florida
city: Merritt Island
country: United States
facility: Merritt Island Medical Research, LLC
state: Florida
city: Naples
country: United States
facility: Collier Neurologic Specialists
state: Florida
city: New Port Richey
country: United States
facility: Suncoast Clinical Research Inc.
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Orlando
country: United States
facility: Synexus Clinical Research
state: Florida
city: Ormond Beach
country: United States
facility: Neurology Associates of Ormond Beach
state: Florida
city: Pompano Beach
country: United States
facility: Quantum Lab CNS Clinical Research
state: Florida
city: Port Orange
country: United States
facility: Progressive Medical Research
state: Florida
city: Sarasota
country: United States
facility: Intercoastal Medical Group
state: Florida
city: Tampa
country: United States
facility: Stedman Clinical Trials, LLC
state: Florida
city: Tampa
country: United States
facility: Meridien Research
state: Florida
city: The Villages
country: United States
facility: Synexus The Villages
state: Florida
city: Decatur
country: United States
facility: NeuroStudies.net, LLC
state: Georgia
city: Chicago
country: United States
facility: Great Lakes Clinical Trials
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Wichita
country: United States
facility: Alliance Multispecialty Research
state: Kansas
city: Lawrence
country: United States
facility: Activmed Practices&Research
state: Massachusetts
city: Farmington Hills
country: United States
facility: Quest Research Institute
state: Michigan
city: Saint Louis
country: United States
facility: Barnes-Jewish Hospital IDS
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska Medical Center-Hematology/Oncology Section
state: Nebraska
city: Omaha
country: United States
facility: Cognitive Clinical Trials, LLC
state: Nebraska
city: Las Vegas
country: United States
facility: Altea Research Institute, Las Vegas
state: Nevada
city: Princeton
country: United States
facility: Global Medical Institutes, LLC
state: New Jersey
city: Springfield
country: United States
facility: The Cognitive Research Center of New Jersey
state: New Jersey
city: Toms River
country: United States
facility: Advanced Memory Research Institute of NJ, PC
state: New Jersey
city: Brooklyn
country: United States
facility: Integrative Clinical Trials LLC
state: New York
city: Buffalo
country: United States
facility: UBMD Neurology
state: New York
city: East Syracuse
country: United States
facility: Clarity Clinical Research
state: New York
city: Staten Island
country: United States
facility: Richmond Behavioral Associates
state: New York
city: Charlotte
country: United States
facility: Behavioral Health Research Center
state: North Carolina
city: Charlotte
country: United States
facility: AMC Research, LLC
state: North Carolina
city: Greensboro
country: United States
facility: Guilford Neurologic Associate
state: North Carolina
city: Beachwood
country: United States
facility: Insight Clinical Trials LLC
state: Ohio
city: Cincinnati
country: United States
facility: New Horizons Clinical Research
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Westerville
country: United States
facility: Columbus Neuroscience, LLC
state: Ohio
city: Portland
country: United States
facility: Summit Research Network(Oregon)Inc.
state: Oregon
city: Portland
country: United States
facility: Oregon Health&Science Universty
state: Oregon
city: Springfield
country: United States
facility: Oregon Neurology Associates
state: Oregon
city: Abington
country: United States
facility: Abington Neurological Associates, LTD
state: Pennsylvania
city: Charleston
country: United States
facility: SCarolina Institute Brain Health
state: South Carolina
city: Dallas
country: United States
facility: Kerwin Research Center
state: Texas
city: Houston
country: United States
facility: Huston Methodist Hospital
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas; Inc
state: Texas
city: West Jordan
country: United States
facility: Advanced Clinical Research
state: Utah
city: Fairfax
country: United States
facility: Cognition Health
state: Virginia
city: Seattle
country: United States
facility: University Washington MedCentre
state: Washington
city: Hornsby
country: Australia
facility: Hornsby Ku-ring-gai Hospital
state: New South Wales
city: Macquarie Park
country: Australia
facility: KaRa MINDS
state: New South Wales
city: Melbourne
country: Australia
facility: Austin Health - Heidelberg Repatriation Hospital
state: Victoria
city: Nedlands
country: Australia
facility: Alzheimer's Research Foundation
state: Western Australia
city: Calgary
country: Canada
facility: Heritage Medical Research Clinic
state: Alberta
city: Kamloops
country: Canada
facility: The Medical Arts Health Research Group
state: British Columbia
city: Kelowna
country: Canada
facility: Okanagan Clinical Trials
state: British Columbia
city: Kelowna
country: Canada
facility: MedicalArtsHealth Research Grp
state: British Columbia
city: Penticton
country: Canada
facility: MedicalArtsHealth Research Grp
state: British Columbia
city: Victoria
country: Canada
facility: Vancouver Island Health Authority
state: British Columbia
city: West Vancouver
country: Canada
facility: Medical Arts Health Research Grp
state: British Columbia
city: Halifax
country: Canada
facility: True North Clinical Research Inc
state: Nova Scotia
city: New Minas
country: Canada
facility: True North Clinical Research
state: Nova Scotia
city: Ottawa
country: Canada
facility: Recherches Neuro-Hippocampe Inc., d/b/a Ottawa Memory Clinic
state: Ontario
city: Toronto
country: Canada
facility: Toronto Memory Program
state: Ontario
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
city: Gatineau
country: Canada
facility: Clinique Memoire Outaouais
state: Quebec
city: Sherbrooke
country: Canada
facility: Q & T Research Sherbrooke Inc
state: Quebec
city: Sherbrooke
country: Canada
facility: Diex Recherche Sherbrooke
state: Quebec
city: Verdun
country: Canada
facility: Douglas Hospital Research Centre
state: Quebec
city: Quebec
country: Canada
facility: ALPHA Recherche Clinique
city: Hefei
country: China
facility: 1st Hospital of Anhui MU
state: Anhui
city: Beijing
country: China
facility: Peking Union Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University 1st Hospital
state: Beijing
city: Beijing
country: China
facility: Xuanwu Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Tiantan Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Anding Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Tong Ren Hospital
state: Beijing
city: Chongqing
country: China
facility: 1st Hospital of Chongqing MU
state: Chongqing
city: Fuzhou
country: China
facility: Fujian Union Hospital
state: Fujian
city: Fuzhou
country: China
facility: 1st Hospital of Fujian MU
state: Fujian
city: Xiamen
country: China
facility: Zhongshan Hospital Xiamen U
state: Fujian
city: Guangzhou
country: China
facility: 1st Hospital of Guangzhou MU
state: Guangdong
city: Guangzhou
country: China
facility: Guangzhou 1st People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: 2nd Hospital of Guangzhou MU
state: Guangdong
city: Guangzhou
country: China
facility: 2nd Hospital Zhongshan University
state: Guangdong
city: Shenzhen
country: China
facility: Kangning Hospital of Shenzhen
state: Guangdong
city: Shijiazhuang
country: China
facility: 1st Hospital of Hebei MU
state: Hebei
city: Tangshan
country: China
facility: Tangshan Gongren Hospital
state: Hebei
city: Changsha
country: China
facility: Xiangya Hospital
state: Hunan
city: Yueyang
country: China
facility: Yueyang 1st People's Hospital
state: Hunan
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Zhong Da Hospital
state: Jiangsu
city: Suzhou
country: China
facility: 2nd Hospital Soochow University
state: Jiangsu
city: Nanchang
country: China
facility: Jiangxi Provincial Hospital
state: Jiangxi
city: Changchun
country: China
facility: 1st Hospital Jilin University
state: Jilin
city: Yinchuan
country: China
facility: General Hospital of Ningxia MU
state: Ningxia Hui Autonomous Region
city: Xi'an
country: China
facility: Tang Du Hospital
state: Shaanxi
city: Xi'an
country: China
facility: Xi'an Mental Health Cente
state: Shaanxi
city: Jinan
country: China
facility: Qilu Hospital
state: Shandong
city: Jinan
country: China
facility: Shandong Provincial Hospital
state: Shandong
city: Qingdao
country: China
facility: Qingdao Municipal Hospital
state: Shandong
city: Shanghai
country: China
facility: Ruijin Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Mental Health Center
state: Shanghai
city: Shanghai
country: China
facility: Huashan Hospital; Fudan U
state: Shanghai
city: Shanghai
country: China
facility: Shanghai General Hospital
state: Shanghai
city: Taiyuan
country: China
facility: 1st Hospital of Shanxi MU
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital
state: Sichuan
city: Tianjin
country: China
facility: Tianjin MU General Hospital
state: Tianjin
city: Tianjin
country: China
facility: Tianjin Huanhu Hospital
state: Tianjin
city: Kunming
country: China
facility: 1st Hospital of Kunming MU
state: Yunnan
city: Hangzhou
country: China
facility: Zhejiang Provincial Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: 1st Hospital Zhejiang University
state: Zhejiang
city: Wenzhou
country: China
facility: 1st Hospital of Wenzhou MU
state: Zhejiang
city: Hradec Králové
country: Czechia
facility: NeuropsychiatrieHK s.r.o.
city: Kladno
country: Czechia
facility: BRAIN-SOULTHERAPY s.r.o.
city: Kutná Hora
country: Czechia
facility: Neuroterapie KH s.r.o.
city: Praha 10
country: Czechia
facility: Clintrial s.r.o.
city: Praha
country: Czechia
facility: FORBELI s.r.o.
city: Praha
country: Czechia
facility: Neuropsychiatrie s.r.o.
city: Strasbourg
country: France
facility: Centred Investigation Clinique
state: Bas Rhin
city: Marseille
country: France
facility: CHUTimone Adultes Service
state: Bouches-du-Rhône
city: Montpellier
country: France
facility: HOPITAL Gui de CHAULIAC
state: Cedex 5
city: Dijon
country: France
facility: Centre Memoire Ressources
state: De Lattre De Tassigny
city: Bordeaux
country: France
facility: Groupe Hospitalier Pellegrin
state: Gironde
city: Colmar
country: France
facility: Hopitaux Civils de Colmar
state: Grand Est
city: Toulouse
country: France
facility: Recherche Clinique Gerontopole
state: Haute Garonne
city: Rennes
country: France
facility: Pharmacie CHU de Rennes
state: Ille Et Vilaine
city: Tonnerre
country: France
facility: CHU Tours-Hopital Bretonneau
state: Indre Et Loire
city: Nantes
country: France
facility: CHU Nantes-Hopital Nord Laennec
state: Loire Atlantique
city: Reims
country: France
facility: CHU Reims-Hopital Maison Blanche
state: Marne
city: Bron
country: France
facility: Neurologique Pierre Wertheimer
state: Rhone
city: Villeurbanne
country: France
facility: Hopital des Charpennes
state: Rhone
city: Paris
country: France
facility: CMRR Paris Nord
city: Shatin
country: Hong Kong
facility: Prince of Wales Hospital
city: Amsterdam
country: Netherlands
facility: VUmc Goederenontvangst
state: Van Der Boechorststraat 6
city: Breda
country: Netherlands
facility: Amphia Hospital Breda
city: Herzogenbusch
country: Netherlands
facility: Pharmacy Jeroen Bosch Ziekenhuis
city: Zwolle
country: Netherlands
facility: Klinische Farmacie
city: Bialystok
country: Poland
facility: Podlaskie Centrum Psychogeriatri
city: Bydgoszcz
country: Poland
facility: NZOZ Vitamed
city: Katowice
country: Poland
facility: Wielospec. Poradnia Lekarska
city: Katowice
country: Poland
facility: Nzoz Novo Med
city: Kraków
country: Poland
facility: Specjalistyczne Gabinety Sp.zo.o
city: Lublin
country: Poland
facility: NZOZ Neuromed MiMNastajSpp
city: Oświęcim
country: Poland
facility: Medicome Sp z o o
city: Poznań
country: Poland
facility: Solumed Centrum Medyczne
city: Warszawa
country: Poland
facility: Neuro Protect
city: Wrocław
country: Poland
facility: Wrclawskie Cntrm Alzheimerowskie
city: Zabrze
country: Poland
facility: Wielospecjalistyczne Centrm Med
city: Taipei
country: Taiwan
facility: National Taiwan UniversityHosp
city: Taipei
country: Taiwan
facility: Tri Service General Hospital
city: Taoyuan
country: Taiwan
facility: Chang GungMemorial Hosp Linkou
Study officials:
affiliation: Green Valley (Shanghai) Pharmaceuticals Co., Ltd.
name: Study Director, Ph D
role: STUDY_DIRECTOR
References: