An Extension Study of ABBV-8E12 in Early Alzheimer's Disease (AD)
NCT ID: NCT03712787
Last Updated: 2022-09-22
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
364 participants
INTERVENTIONAL
2019-03-22
2021-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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300 mg/1000 mg Tilavonemab
Participants who received 300 mg tilavonemab in Study M15-566 receive 1000 mg tilavonemab in Study M15-570 via intravenous (IV) infusion every 4 weeks for up to 5.5 years.
Tilavonemab
solution for IV infusion
1000 mg/1000 mg Tilavonemab
Participants who received 1000 mg tilavonemab in Study M15-566 continue on the same dose in Study M15-570 via IV infusion every 4 weeks for up to 5.5 years.
Tilavonemab
solution for IV infusion
2000 mg/2000 mg Tilavonemab
Participants who received 2000 mg tilavonemab in Study M15-566 continue on the same dose in Study M15-570 via IV infusion every 4 weeks for up to 5.5 years.
Tilavonemab
solution for IV infusion
PBO/2000 mg Tilavonemab
Participants who received placebo (PBO) in Study M15-566 receive 2000 mg tilavonemab in Study M15-570 via IV infusion every 4 weeks for up to 5.5 years.
Tilavonemab
solution for IV infusion
Interventions
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Tilavonemab
solution for IV infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject has an identified, reliable study partner who has frequent contact with the subject and who will provide information as to the subject's cognitive and functional abilities
Exclusion Criteria
* More than 8 weeks have elapsed since the subject received his/her last dose of study drug in Study M15-566 (NCT02880956)
* The subject is concurrently enrolled in another interventional clinical study involving a therapeutic agent with the exception of Study M15-566 (NCT02880956)
57 Years
88 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Banner University of Arizona Medical Center Phoenix /ID# 203959
Phoenix, Arizona, United States
Irvine Clinical Research /ID# 204000
Irvine, California, United States
Ucsd /Id# 204001
La Jolla, California, United States
University of California, San /ID# 204011
San Francisco, California, United States
Brain Matters Research /ID# 203957
Delray Beach, Florida, United States
Neuropsychiatric Research Center of Southwest Florida /ID# 203956
Fort Myers, Florida, United States
Mayo Clinic /ID# 203995
Jacksonville, Florida, United States
Synexus Clinical Research US, Inc. /ID# 203992
Orlando, Florida, United States
University of South Florida /ID# 204009
Tampa, Florida, United States
Synexus Clinical Research US, Inc /ID# 204010
The Villages, Florida, United States
Emory University / Emory Brain Health Center /ID# 203999
Atlanta, Georgia, United States
NeuroStudies.net, LLC /ID# 204004
Decatur, Georgia, United States
Advocate Lutheran General Hospital /ID# 203993
Park Ridge, Illinois, United States
Southern IL Univ School of Med /ID# 203952
Springfield, Illinois, United States
Indiana University /ID# 203989
Indianapolis, Indiana, United States
University of Kansas Medical Center - Alzheimer's Disease Center /ID# 203960
Fairway, Kansas, United States
University of Kentucky Chandler Medical Center /ID# 203996
Lexington, Kentucky, United States
Massachusetts General Hospital /ID# 203954
Boston, Massachusetts, United States
Brigham and Women's Physicians /ID# 204003
Boston, Massachusetts, United States
Hattiesburg Clinic /ID# 213435
Hattiesburg, Mississippi, United States
Princeton Medical Institute /ID# 203953
Princeton, New Jersey, United States
North Shore University Hospital /ID# 203994
New Hyde Park, New York, United States
Duke Univ Med Ctr /ID# 203958
Durham, North Carolina, United States
Oregon Health and Science University /ID# 203997
Portland, Oregon, United States
Keystone Clinical Studies LLC /ID# 213183
Plymouth Meeting, Pennsylvania, United States
Rhode Island Hospital /ID# 204005
Providence, Rhode Island, United States
Vanderbilt Ingram Cancer Center /ID# 203951
Nashville, Tennessee, United States
Kerwin Research Center /ID# 203998
Dallas, Texas, United States
Houston Methodist Hospital /ID# 204002
Houston, Texas, United States
McGovern Medical School /ID# 213312
Houston, Texas, United States
University of Utah /ID# 203991
Salt Lake City, Utah, United States
Integrated Neurology Services /ID# 203990
Alexandria, Virginia, United States
St Vincent's Centre for Applied Medical Research /ID# 204903
Darlinghurst, New South Wales, Australia
Griffith University /ID# 204905
Southport, Queensland, Australia
Austin Health /ID# 204906
Heidelberg, Victoria, Australia
Australian Alzheimer's Res Fou /ID# 204904
Nedlands, Western Australia, Australia
UCL Saint-Luc /ID# 204963
Woluwe-Saint-Lambert, Brussels Capital, Belgium
Universitair Ziekenhuis Leuven /ID# 204965
Leuven, Vlaams-Brabant, Belgium
Groupe Sante CHC - Clinique du MontLegia /ID# 204964
Liège, , Belgium
Parkwood Institute /ID# 204121
London, Ontario, Canada
Toronto Memory Program /ID# 204120
Toronto, Ontario, Canada
Rigshospitalet /ID# 204591
Copenhagen Ø, Capital Region, Denmark
Clinical Research Services Turku /ID# 205924
Turku, Southwest Finland, Finland
Ita-Suomen Yliopisto /ID# 204538
Kuopio, , Finland
AOU di Modena /ID# 203904
Modena, Emilia-Romagna, Italy
Policlinico Agostino Gemelli /ID# 203906
Rome, Lazio, Italy
Azienda Ospedaliera di Perugia /ID# 203905
Perugia, Umbria, Italy
IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli /ID# 203903
Brescia, , Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 203902
Milan, , Italy
ASST Grande Ospedale Metropolitano Niguarda /ID# 203901
Milan, , Italy
CGM Research Trust /ID# 204907
Burwood, , New Zealand
Fundacion CITA Alzheimer Fundazioa /ID# 204521
Donostia / San Sebastian, Basque Country, Spain
Fundacio ACE /ID# 204520
Barcelona, , Spain
Hospital Clinic de Barcelona /ID# 204519
Barcelona, , Spain
Hospital Universitario 12 de Octubre /ID# 204518
Madrid, , Spain
Karolinska University Hospital Huddinge /ID# 203900
Stockholm, Stockholm County, Sweden
Sahlgrenska University Hospital Molndal /ID# 203899
Mölndal, Västra Götaland County, Sweden
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2018-000268-26
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M15-570
Identifier Type: -
Identifier Source: org_study_id
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