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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT04520412
Other study ID # GV971-007
Secondary ID
Status Suspended
Phase Phase 3
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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