A Study of Sodium Oligomannate (GV-971) in Participants With Mild to Moderate Alzheimer's Disease
- Registration Number
- NCT04520412
- Lead Sponsor
- Green Valley (Shanghai) Pharmaceuticals Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 2046
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description GV-971 GV-971 - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Change from baseline in the ADCS-CGIC score 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.
Change from baseline in the ADAS-cog/11 score 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.
- Secondary Outcome Measures
Name Time Method Assess the efficacy of GV-971 throughout the OLE period 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.
Change from baseline in NPI score 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.
Change from baseline in MMSE score 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.
Change from baseline in ADCS-ADL23 score 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.
Change from baseline in NPI caregiver items 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.
Change from baseline in ZBI score 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.
Related Research Topics
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Trial Locations
- Locations (168)
NZOZ Neuromed MiMNastajSpp
🇵🇱Lublin, Poland
Schuster Med Research Institute
🇺🇸Sherman Oaks, California, United States
FORBELI s.r.o.
🇨🇿Praha, Czechia
Tri Service General Hospital
🇨🇳Taipei, Taiwan
Wrclawskie Cntrm Alzheimerowskie
🇵🇱Wrocław, Poland
Neurologique Pierre Wertheimer
🇫🇷Bron, Rhone, France
Wielospecjalistyczne Centrm Med
🇵🇱Zabrze, Poland
Brain Matters Research
🇺🇸Delray Beach, Florida, United States
Clarity Clinical Research
🇺🇸East Syracuse, New York, United States
Guilford Neurologic Associate
🇺🇸Greensboro, North Carolina, United States
Global Medical Institutes, LLC
🇺🇸Princeton, New Jersey, United States
Quest Research Institute
🇺🇸Farmington Hills, Michigan, United States
Vancouver Island Health Authority
🇨🇦Victoria, British Columbia, Canada
Toronto Memory Program
🇨🇦Toronto, Ontario, Canada
Toronto Western Hospital
🇨🇦Toronto, Ontario, Canada
Diex Recherche Sherbrooke
🇨🇦Sherbrooke, Quebec, Canada
CHUTimone Adultes Service
🇫🇷Marseille, Bouches-du-Rhône, France
1st Hospital of Anhui MU
🇨🇳Hefei, Anhui, China
Xuanwu Hospital
🇨🇳Beijing, Beijing, China
Fujian Union Hospital
🇨🇳Fuzhou, Fujian, China
1st Hospital of Fujian MU
🇨🇳Fuzhou, Fujian, China
Zhongshan Hospital Xiamen U
🇨🇳Xiamen, Fujian, China
1st Hospital of Hebei MU
🇨🇳Shijiazhuang, Hebei, China
1st Hospital of Guangzhou MU
🇨🇳Guangzhou, Guangdong, China
Guangzhou 1st People's Hospital
🇨🇳Guangzhou, Guangdong, China
2nd Hospital of Guangzhou MU
🇨🇳Guangzhou, Guangdong, China
Tang Du Hospital
🇨🇳Xi'an, Shaanxi, China
Tangshan Gongren Hospital
🇨🇳Tangshan, Hebei, China
Zhong Da Hospital
🇨🇳Nanjing, Jiangsu, China
2nd Hospital Soochow University
🇨🇳Suzhou, Jiangsu, China
Shandong Provincial Hospital
🇨🇳Jinan, Shandong, China
1st Hospital Zhejiang University
🇨🇳Hangzhou, Zhejiang, China
Chang GungMemorial Hosp Linkou
🇨🇳Taoyuan, Taiwan
Douglas Hospital Research Centre
🇨🇦Verdun, Quebec, Canada
St. Joseph's Hospital and Medical Center
🇺🇸Phoenix, Arizona, United States
Indiana University
🇺🇸Indianapolis, Indiana, United States
New Horizons Clinical Research
🇺🇸Cincinnati, Ohio, United States
Cognitive Clinical Trials, LLC
🇺🇸Omaha, Nebraska, United States
Pacific Research Network
🇺🇸San Diego, California, United States
University of Nebraska Medical Center-Hematology/Oncology Section
🇺🇸Omaha, Nebraska, United States
Huston Methodist Hospital
🇺🇸Houston, Texas, United States
Summit Research Network(Oregon)Inc.
🇺🇸Portland, Oregon, United States
Clinical Trials of Texas; Inc
🇺🇸San Antonio, Texas, United States
University Washington MedCentre
🇺🇸Seattle, Washington, United States
Banner Alzheimer's Institute
🇺🇸Tucson, Arizona, United States
Irvine Clinical Research
🇺🇸Irvine, California, United States
Banner Sun Health Research Institute
🇺🇸Sun City, Arizona, United States
Pacific Research Network, Inc
🇺🇸San Diego, California, United States
Sunwise Clinical Research
🇺🇸Lafayette, California, United States
Pharmacology Research Institute
🇺🇸Los Alamitos, California, United States
Syrentis Clinical Research
🇺🇸Santa Ana, California, United States
JEM Research LLC
🇺🇸Atlantis, Florida, United States
Jacksonville Center for Clinical Research
🇺🇸Jacksonville, Florida, United States
Velocity Clinical Research
🇺🇸Hallandale Beach, Florida, United States
Finlay Medical Research Corp
🇺🇸Greenacres City, Florida, United States
Charter Research, LLC
🇺🇸Lady Lake, Florida, United States
Innovative Clinical Research, Inc.
🇺🇸Lauderhill, Florida, United States
Merritt Island Medical Research, LLC
🇺🇸Merritt Island, Florida, United States
Suncoast Clinical Research Inc.
🇺🇸New Port Richey, Florida, United States
Quantum Lab CNS Clinical Research
🇺🇸Pompano Beach, Florida, United States
Progressive Medical Research
🇺🇸Port Orange, Florida, United States
Neurology Associates of Ormond Beach
🇺🇸Ormond Beach, Florida, United States
Intercoastal Medical Group
🇺🇸Sarasota, Florida, United States
NeuroStudies.net, LLC
🇺🇸Decatur, Georgia, United States
Great Lakes Clinical Trials
🇺🇸Chicago, Illinois, United States
Activmed Practices&Research
🇺🇸Lawrence, Massachusetts, United States
Synexus The Villages
🇺🇸The Villages, Florida, United States
Alliance Multispecialty Research
🇺🇸Wichita, Kansas, United States
Altea Research Institute, Las Vegas
🇺🇸Las Vegas, Nevada, United States
Barnes-Jewish Hospital IDS
🇺🇸Saint Louis, Missouri, United States
Advanced Memory Research Institute of NJ, PC
🇺🇸Toms River, New Jersey, United States
The Cognitive Research Center of New Jersey
🇺🇸Springfield, New Jersey, United States
Integrative Clinical Trials LLC
🇺🇸Brooklyn, New York, United States
UBMD Neurology
🇺🇸Buffalo, New York, United States
Richmond Behavioral Associates
🇺🇸Staten Island, New York, United States
Behavioral Health Research Center
🇺🇸Charlotte, North Carolina, United States
Insight Clinical Trials LLC
🇺🇸Beachwood, Ohio, United States
AMC Research, LLC
🇺🇸Charlotte, North Carolina, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Columbus Neuroscience, LLC
🇺🇸Westerville, Ohio, United States
Oregon Health&Science Universty
🇺🇸Portland, Oregon, United States
Oregon Neurology Associates
🇺🇸Springfield, Oregon, United States
Abington Neurological Associates, LTD
🇺🇸Abington, Pennsylvania, United States
Kerwin Research Center
🇺🇸Dallas, Texas, United States
Advanced Clinical Research
🇺🇸West Jordan, Utah, United States
Hornsby Ku-ring-gai Hospital
🇦🇺Hornsby, New South Wales, Australia
Cognition Health
🇺🇸Fairfax, Virginia, United States
Heritage Medical Research Clinic
🇨🇦Calgary, Alberta, Canada
KaRa MINDS
🇦🇺Macquarie Park, New South Wales, Australia
Austin Health - Heidelberg Repatriation Hospital
🇦🇺Melbourne, Victoria, Australia
The Medical Arts Health Research Group
🇨🇦Kamloops, British Columbia, Canada
Okanagan Clinical Trials
🇨🇦Kelowna, British Columbia, Canada
MedicalArtsHealth Research Grp
🇨🇦Penticton, British Columbia, Canada
True North Clinical Research Inc
🇨🇦Halifax, Nova Scotia, Canada
Recherches Neuro-Hippocampe Inc., d/b/a Ottawa Memory Clinic
🇨🇦Ottawa, Ontario, Canada
Clinique Memoire Outaouais
🇨🇦Gatineau, Quebec, Canada
True North Clinical Research
🇨🇦New Minas, Nova Scotia, Canada
Q & T Research Sherbrooke Inc
🇨🇦Sherbrooke, Quebec, Canada
ALPHA Recherche Clinique
🇨🇦Quebec, Canada
Peking Union Hospital
🇨🇳Beijing, Beijing, China
Beijing Tiantan Hospital
🇨🇳Beijing, Beijing, China
Peking University 1st Hospital
🇨🇳Beijing, Beijing, China
1st Hospital of Chongqing MU
🇨🇳Chongqing, Chongqing, China
Beijing Tong Ren Hospital
🇨🇳Beijing, Beijing, China
Beijing Hospital
🇨🇳Beijing, Beijing, China
Beijing Anding Hospital
🇨🇳Beijing, Beijing, China
Kangning Hospital of Shenzhen
🇨🇳Shenzhen, Guangdong, China
Xiangya Hospital
🇨🇳Changsha, Hunan, China
Yueyang 1st People's Hospital
🇨🇳Yueyang, Hunan, China
Nanjing Drum Tower Hospital
🇨🇳Nanjing, Jiangsu, China
Jiangxi Provincial Hospital
🇨🇳Nanchang, Jiangxi, China
1st Hospital Jilin University
🇨🇳Changchun, Jilin, China
General Hospital of Ningxia MU
🇨🇳Yinchuan, Ningxia Hui Autonomous Region, China
Qilu Hospital
🇨🇳Jinan, Shandong, China
Xi'an Mental Health Cente
🇨🇳Xi'an, Shaanxi, China
Qingdao Municipal Hospital
🇨🇳Qingdao, Shandong, China
Shanghai Mental Health Center
🇨🇳Shanghai, Shanghai, China
Ruijin Hospital
🇨🇳Shanghai, Shanghai, China
Shanghai General Hospital
🇨🇳Shanghai, Shanghai, China
1st Hospital of Shanxi MU
🇨🇳Taiyuan, Shanxi, China
Huashan Hospital; Fudan U
🇨🇳Shanghai, Shanghai, China
West China Hospital
🇨🇳Chengdu, Sichuan, China
Tianjin MU General Hospital
🇨🇳Tianjin, Tianjin, China
Zhejiang Provincial Hospital
🇨🇳Hangzhou, Zhejiang, China
Tianjin Huanhu Hospital
🇨🇳Tianjin, Tianjin, China
1st Hospital of Kunming MU
🇨🇳Kunming, Yunnan, China
1st Hospital of Wenzhou MU
🇨🇳Wenzhou, Zhejiang, China
NeuropsychiatrieHK s.r.o.
🇨🇿Hradec Králové, Czechia
Neuroterapie KH s.r.o.
🇨🇿Kutná Hora, Czechia
Neuropsychiatrie s.r.o.
🇨🇿Praha, Czechia
BRAIN-SOULTHERAPY s.r.o.
🇨🇿Kladno, Czechia
Clintrial s.r.o.
🇨🇿Praha 10, Czechia
Centred Investigation Clinique
🇫🇷Strasbourg, Bas Rhin, France
HOPITAL Gui de CHAULIAC
🇫🇷Montpellier, Cedex 5, France
Recherche Clinique Gerontopole
🇫🇷Toulouse, Haute Garonne, France
Centre Memoire Ressources
🇫🇷Dijon, De Lattre De Tassigny, France
Hopitaux Civils de Colmar
🇫🇷Colmar, Grand Est, France
Groupe Hospitalier Pellegrin
🇫🇷Bordeaux, Gironde, France
Pharmacie CHU de Rennes
🇫🇷Rennes, Ille Et Vilaine, France
CHU Reims-Hopital Maison Blanche
🇫🇷Reims, Marne, France
CHU Nantes-Hopital Nord Laennec
🇫🇷Nantes, Loire Atlantique, France
CHU Tours-Hopital Bretonneau
🇫🇷Tonnerre, Indre Et Loire, France
Hopital des Charpennes
🇫🇷Villeurbanne, Rhone, France
CMRR Paris Nord
🇫🇷Paris, France
VUmc Goederenontvangst
🇳🇱Amsterdam, Van Der Boechorststraat 6, Netherlands
Pharmacy Jeroen Bosch Ziekenhuis
🇳🇱Herzogenbusch, Netherlands
Amphia Hospital Breda
🇳🇱Breda, Netherlands
Klinische Farmacie
🇳🇱Zwolle, Netherlands
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
Solumed Centrum Medyczne
🇵🇱Poznań, Poland
Neuro Protect
🇵🇱Warszawa, Poland
National Taiwan UniversityHosp
🇨🇳Taipei, Taiwan
Medicome Sp z o o
🇵🇱Oświęcim, Poland
Clinical Neuroscience Solutions, Inc.
🇺🇸Orlando, Florida, United States
Meridien Research
🇺🇸Tampa, Florida, United States
Synexus Clinical Research
🇺🇸Orlando, Florida, United States
Stedman Clinical Trials, LLC
🇺🇸Tampa, Florida, United States
SCarolina Institute Brain Health
🇺🇸Charleston, South Carolina, United States
Alzheimer's Research Foundation
🇦🇺Nedlands, Western Australia, Australia
ClinCloud, LLC
🇺🇸Maitland, Florida, United States
Collier Neurologic Specialists
🇺🇸Naples, Florida, United States
Medical Arts Health Research Grp
🇨🇦West Vancouver, British Columbia, Canada
2nd Hospital Zhongshan University
🇨🇳Guangzhou, Guangdong, China
Prince of Wales Hospital
🇭🇰Shatin, Hong Kong