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The quality of study was seriously affected by the COVID-19, so it was decided to suspend the trial and restart it at the right time.
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The purpose of this study is to evaluate the safety, tolerability and efficacy of GV-971 in mild to moderate Alzheimer's disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GV-971 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GV-971 | Drug | Administered PO |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change from baseline in MMSE score |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the population PK | 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 | Changes from baseline in volumetric magnetic resonance imaging (MRI) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director, Ph D | Green Valley (Shanghai) Pharmaceuticals Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cognitive Clinical Trials, LLC | Gilbert | Arizona | 85297 | United States | ||
| Banner Alzheimer's Institute |
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| Drug |
Administered PO |
|
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 | 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 | 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 | 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 | 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 | 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 |
| Baseline, 52 Weeks |
| Phoenix |
| Arizona |
| 85006 |
| United States |
| St. Joseph's Hospital and Medical Center | Phoenix | Arizona | 85013 | United States |
| Banner Sun Health Research Institute | Sun City | Arizona | 85351 | United States |
| Banner Alzheimer's Institute | Tucson | Arizona | 85718 | United States |
| Irvine Clinical Research | Irvine | California | 92614 | United States |
| Sunwise Clinical Research | Lafayette | California | 94549 | United States |
| Pharmacology Research Institute | Los Alamitos | California | 90720 | United States |
| Pacific Research Network, Inc | San Diego | California | 92103 | United States |
| Pacific Research Network | San Diego | California | 92103 | United States |
| Syrentis Clinical Research | Santa Ana | California | 92705 | United States |
| Schuster Med Research Institute | Sherman Oaks | California | 91403 | United States |
| JEM Research LLC | Atlantis | Florida | 33462 | United States |
| Brain Matters Research | Delray Beach | Florida | 33445 | United States |
| Finlay Medical Research Corp | Greenacres City | Florida | 33467 | United States |
| Velocity Clinical Research | Hallandale | Florida | 33009 | United States |
| Jacksonville Center for Clinical Research | Jacksonville | Florida | 32216 | United States |
| Charter Research, LLC | Lady Lake | Florida | 32159 | United States |
| Innovative Clinical Research, Inc. | Lauderhill | Florida | 33319 | United States |
| ClinCloud, LLC | Maitland | Florida | 32751 | United States |
| Merritt Island Medical Research, LLC | Merritt Island | Florida | 32952 | United States |
| Collier Neurologic Specialists | Naples | Florida | 34105 | United States |
| Suncoast Clinical Research Inc. | New Port Richey | Florida | 34652 | United States |
| Clinical Neuroscience Solutions, Inc. | Orlando | Florida | 32801 | United States |
| Synexus Clinical Research | Orlando | Florida | 32806 | United States |
| Neurology Associates of Ormond Beach | Ormond Beach | Florida | 32174 | United States |
| Quantum Lab CNS Clinical Research | Pompano Beach | Florida | 33064 | United States |
| Progressive Medical Research | Port Orange | Florida | 32127 | United States |
| Intercoastal Medical Group | Sarasota | Florida | 34239 | United States |
| Stedman Clinical Trials, LLC | Tampa | Florida | 33613 | United States |
| Meridien Research | Tampa | Florida | 33634 | United States |
| Synexus The Villages | The Villages | Florida | 32162 | United States |
| NeuroStudies.net, LLC | Decatur | Georgia | 30033 | United States |
| Great Lakes Clinical Trials | Chicago | Illinois | 60640 | United States |
| Indiana University | Indianapolis | Indiana | 46202 | United States |
| Alliance Multispecialty Research | Wichita | Kansas | 67207 | United States |
| Activmed Practices&Research | Lawrence | Massachusetts | 01843 | United States |
| Quest Research Institute | Farmington Hills | Michigan | 48334 | United States |
| Barnes-Jewish Hospital IDS | St Louis | Missouri | 63110 | United States |
| University of Nebraska Medical Center-Hematology/Oncology Section | Omaha | Nebraska | 68106 | United States |
| Cognitive Clinical Trials, LLC | Omaha | Nebraska | 68130 | United States |
| Altea Research Institute, Las Vegas | Las Vegas | Nevada | 89102 | United States |
| Global Medical Institutes, LLC | Princeton | New Jersey | 08540 | United States |
| The Cognitive Research Center of New Jersey | Springfield | New Jersey | 07081 | United States |
| Advanced Memory Research Institute of NJ, PC | Toms River | New Jersey | 08755 | United States |
| Integrative Clinical Trials LLC | Brooklyn | New York | 11229 | United States |
| UBMD Neurology | Buffalo | New York | 14203 | United States |
| Clarity Clinical Research | East Syracuse | New York | 13057 | United States |
| Richmond Behavioral Associates | Staten Island | New York | 10312 | United States |
| Behavioral Health Research Center | Charlotte | North Carolina | 28211 | United States |
| AMC Research, LLC | Charlotte | North Carolina | 28270 | United States |
| Guilford Neurologic Associate | Greensboro | North Carolina | 27405 | United States |
| Insight Clinical Trials LLC | Beachwood | Ohio | 44122 | United States |
| New Horizons Clinical Research | Cincinnati | Ohio | 45040 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Columbus Neuroscience, LLC | Westerville | Ohio | 43082 | United States |
| Summit Research Network(Oregon)Inc. | Portland | Oregon | 97210 | United States |
| Oregon Health&Science Universty | Portland | Oregon | 97239 | United States |
| Oregon Neurology Associates | Springfield | Oregon | 97477 | United States |
| Abington Neurological Associates, LTD | Abington | Pennsylvania | 19001 | United States |
| SCarolina Institute Brain Health | Charleston | South Carolina | 29401 | United States |
| Kerwin Research Center | Dallas | Texas | 75231 | United States |
| Huston Methodist Hospital | Houston | Texas | 77030 | United States |
| Clinical Trials of Texas; Inc | San Antonio | Texas | 78229 | United States |
| Advanced Clinical Research | West Jordan | Utah | 84088 | United States |
| Cognition Health | Fairfax | Virginia | 22031 | United States |
| University Washington MedCentre | Seattle | Washington | 98104-2499 | United States |
| Hornsby Ku-ring-gai Hospital | Hornsby | New South Wales | 2077 | Australia |
| KaRa MINDS | Macquarie Park | New South Wales | 2113 | Australia |
| Austin Health - Heidelberg Repatriation Hospital | Melbourne | Victoria | 3081 | Australia |
| Alzheimer's Research Foundation | Nedlands | Western Australia | 6009 | Australia |
| Heritage Medical Research Clinic | Calgary | Alberta | T2N 4Z6 | Canada |
| The Medical Arts Health Research Group | Kamloops | British Columbia | V2C 5T1 | Canada |
| Okanagan Clinical Trials | Kelowna | British Columbia | V1Y 1Z9 | Canada |
| MedicalArtsHealth Research Grp | Kelowna | British Columbia | V1Y 4N7 | Canada |
| MedicalArtsHealth Research Grp | Penticton | British Columbia | V2A 5L5 | Canada |
| Vancouver Island Health Authority | Victoria | British Columbia | V8R1J8 | Canada |
| Medical Arts Health Research Grp | West Vancouver | British Columbia | V7T 1C5 | Canada |
| True North Clinical Research Inc | Halifax | Nova Scotia | B3M 1N2 | Canada |
| True North Clinical Research | New Minas | Nova Scotia | B4N 3R7 | Canada |
| Recherches Neuro-Hippocampe Inc., d/b/a Ottawa Memory Clinic | Ottawa | Ontario | K1Z 1G3 | Canada |
| Toronto Memory Program | Toronto | Ontario | M3B 2S7 | Canada |
| Toronto Western Hospital | Toronto | Ontario | M5T 2S8 | Canada |
| Clinique Memoire Outaouais | Gatineau | Quebec | J8T 8J1 | Canada |
| Q & T Research Sherbrooke Inc | Sherbrooke | Quebec | J1J 2G2 | Canada |
| Diex Recherche Sherbrooke | Sherbrooke | Quebec | J1L0H8 | Canada |
| Douglas Hospital Research Centre | Verdun | Quebec | H4H 1R3 | Canada |
| ALPHA Recherche Clinique | Québec | Qc G3K 2P8 | Canada |
| 1st Hospital of Anhui MU | Hefei | Anhui | 230022 | China |
| Peking Union Hospital | Beijing | Beijing Municipality | 100032 | China |
| Peking University 1st Hospital | Beijing | Beijing Municipality | 100034 | China |
| Xuanwu Hospital | Beijing | Beijing Municipality | 100053 | China |
| Beijing Tiantan Hospital | Beijing | Beijing Municipality | 100070 | China |
| Beijing Anding Hospital | Beijing | Beijing Municipality | 100088 | China |
| Beijing Hospital | Beijing | Beijing Municipality | 100730 | China |
| Beijing Tong Ren Hospital | Beijing | Beijing Municipality | 100730 | China |
| 1st Hospital of Chongqing MU | Chongqing | Chongqing Municipality | 400016 | China |
| Fujian Union Hospital | Fuzhou | Fujian | 350001 | China |
| 1st Hospital of Fujian MU | Fuzhou | Fujian | 350005 | China |
| Zhongshan Hospital Xiamen U | Xiamen | Fujian | 361004 | China |
| 1st Hospital of Guangzhou MU | Guangzhou | Guangdong | 510120 | China |
| Guangzhou 1st People's Hospital | Guangzhou | Guangdong | 510180 | China |
| 2nd Hospital of Guangzhou MU | Guangzhou | Guangdong | 510260 | China |
| 2nd Hospital Zhongshan University | Guangzhou | Guangdong | 510260 | China |
| Kangning Hospital of Shenzhen | Shenzhen | Guangdong | 518118 | China |
| 1st Hospital of Hebei MU | Shijiazhuang | Hebei | 50030 | China |
| Tangshan Gongren Hospital | Tangshan | Hebei | 63000 | China |
| Xiangya Hospital | Changsha | Hunan | 410008 | China |
| Yueyang 1st People's Hospital | Yueyang | Hunan | 414000 | China |
| Nanjing Drum Tower Hospital | Nanjing | Jiangsu | 210000 | China |
| Zhong Da Hospital | Nanjing | Jiangsu | 210009 | China |
| 2nd Hospital Soochow University | Suzhou | Jiangsu | 215004 | China |
| Jiangxi Provincial Hospital | Nanchang | Jiangxi | 330006 | China |
| 1st Hospital Jilin University | Changchun | Jilin | 130021 | China |
| General Hospital of Ningxia MU | Yinchuan | Ningxia | 750004 | China |
| Tang Du Hospital | Xi'an | Shaanxi | 710038 | China |
| Xi'an Mental Health Cente | Xi'an | Shaanxi | 710061 | China |
| Qilu Hospital | Jinan | Shandong | 250012 | China |
| Shandong Provincial Hospital | Jinan | Shandong | 250021 | China |
| Qingdao Municipal Hospital | Qingdao | Shandong | 266071 | China |
| Ruijin Hospital | Shanghai | Shanghai Municipality | 200020 | China |
| Shanghai Mental Health Center | Shanghai | Shanghai Municipality | 200030 | China |
| Huashan Hospital; Fudan U | Shanghai | Shanghai Municipality | 200040 | China |
| Shanghai General Hospital | Shanghai | Shanghai Municipality | 200080 | China |
| 1st Hospital of Shanxi MU | Taiyuan | Shanxi | 30001 | China |
| West China Hospital | Chengdu | Sichuan | 610041 | China |
| Tianjin MU General Hospital | Tianjin | Tianjin Municipality | 300052 | China |
| Tianjin Huanhu Hospital | Tianjin | Tianjin Municipality | 300060 | China |
| 1st Hospital of Kunming MU | Kunming | Yunnan | 650032 | China |
| Zhejiang Provincial Hospital | Hangzhou | Zhejiang | 310000 | China |
| 1st Hospital Zhejiang University | Hangzhou | Zhejiang | 310003 | China |
| 1st Hospital of Wenzhou MU | Wenzhou | Zhejiang | 325000 | China |
| NeuropsychiatrieHK s.r.o. | Hradec Králové | 50341 | Czechia |
| BRAIN-SOULTHERAPY s.r.o. | Kladno | 27204 | Czechia |
| Neuroterapie KH s.r.o. | Kutná Hora | 28401 | Czechia |
| Clintrial s.r.o. | Prague | 10100 | Czechia |
| FORBELI s.r.o. | Prague | 16000 | Czechia |
| Neuropsychiatrie s.r.o. | Prague | 16100 | Czechia |
| Centred Investigation Clinique | Strasbourg | Bas Rhin | 67098 | France |
| CHUTimone Adultes Service | Marseille | Bouches-du-Rhône | 13005 | France |
| HOPITAL Gui de CHAULIAC | Montpellier | Cedex 5 | 34295 | France |
| Centre Memoire Ressources | Dijon | De Lattre de Tassigny | 21000 | France |
| Groupe Hospitalier Pellegrin | Bordeaux | Gironde | 33076 | France |
| Hopitaux Civils de Colmar | Colmar | Grand Est | 68024 | France |
| Recherche Clinique Gerontopole | Toulouse | Haute Garonne | 31059 | France |
| Pharmacie CHU de Rennes | Rennes | Ille Et Vilaine | 35033 | France |
| CHU Tours-Hopital Bretonneau | Tonnerre | Indre Et Loire | 37044 | France |
| CHU Nantes-Hopital Nord Laennec | Nantes | Loire Atlantique | 44093 | France |
| CHU Reims-Hopital Maison Blanche | Reims | Marne | 51092 | France |
| Neurologique Pierre Wertheimer | Bron | Rhone | 69677 | France |
| Hopital des Charpennes | Villeurbanne | Rhone | 69100 | France |
| CMRR Paris Nord | Paris | 75010 | France |
| Prince of Wales Hospital | Shatin | Hong Kong |
| VUmc Goederenontvangst | Amsterdam | Van Der Boechorststraat 6 | 1081 GN | Netherlands |
| Pharmacy Jeroen Bosch Ziekenhuis | 's-Hertogenbosch | 5223 LA | Netherlands |
| Amphia Hospital Breda | Breda | 4818 C.K | Netherlands |
| Klinische Farmacie | Zwolle | 8025 AB | Netherlands |
| Podlaskie Centrum Psychogeriatri | Bialystok | 15-756 | Poland |
| NZOZ Vitamed | Bydgoszcz | 85-079 | Poland |
| Wielospec. Poradnia Lekarska | Katowice | 40-123 | Poland |
| Nzoz Novo Med | Katowice | 40-650 | Poland |
| Specjalistyczne Gabinety Sp.zo.o | Krakow | 30-539 | Poland |
| NZOZ Neuromed MiMNastajSpp | Lublin | 20-064 | Poland |
| Medicome Sp z o o | Oświęcim | 32-600 | Poland |
| Solumed Centrum Medyczne | Poznan | 60-529 | Poland |
| Neuro Protect | Warsaw | 01-684 | Poland |
| Wrclawskie Cntrm Alzheimerowskie | Wroclaw | 53659 | Poland |
| Wielospecjalistyczne Centrm Med | Zabrze | 41-800 | Poland |
| National Taiwan UniversityHosp | Taipei | 10048 | Taiwan |
| Tri Service General Hospital | Taipei | 11490 | Taiwan |
| Chang GungMemorial Hosp Linkou | Taoyuan | 333 | Taiwan |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000710388 | GV-971 |
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