An Extension Study of ABBV-8E12 in Early Alzheimer's Disease (AD)
- Registration Number
- NCT03712787
- Lead Sponsor
- AbbVie
- Brief Summary
The purpose of this study is to assess the long-term safety and tolerability of ABBV-8E12 in participants with early AD.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 364
- All subjects with early AD who complete Study M15-566 (NCT02880956), meet all inclusion criteria, and do not meet any exclusion criteria are eligible for enrollment
- Subject was compliant during participation in Study M15-566 (NCT02880956)
- 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
- The subject has any significant change in his/her medical condition since participation in Study M15-566 (NCT02880956) that could interfere with the subject's participation in Study M15-570, could place the subject at increased risk, or could confound interpretation of study results
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 300 mg/1000 mg Tilavonemab 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. 1000 mg/1000 mg Tilavonemab 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. 2000 mg/2000 mg Tilavonemab 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. PBO/2000 mg Tilavonemab 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.
- Primary Outcome Measures
Name Time Method Hematology: Number of Participants With Postbaseline Potentially Clinically Significant (PCS) Values Baseline to 20 weeks after last dose of study drug; overall median time on treatment was 279 days. Clinical laboratory PCS criteria were adapted from National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Clinical Chemistry: Percentage of Participants With Postbaseline PCS Values Baseline to 20 weeks after last dose of study drug; overall median time on treatment was 279 days. Clinical laboratory PCS criteria were adapted from NCI CTCAE version 4.03
Brain Magnetic Resonance Imaging (MRI) Results: Number of Participants With Cerebral Edemas, New Microhemorrhage(s), and Severe White Matter Disease Baseline to 20 weeks after last dose of study drug; overall median time on treatment was 279 days. Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation of Study Drug, and Fatal TEAEs From first dose of study drug to 20 weeks after last dose of study drug; overall median time on treatment was 279 days. Treatment emergent adverse events (TEAEs) are defined as any adverse event (AE) from the time of study drug administration until 20 weeks after discontinuation of study drug. An AE is defined as any untoward medical occurrence, which does not necessarily have a causal relationship with treatment. A serious AE (SAE) is defined as any event that: results in death; is life-threatening; results in hospitalization or prolongation of hospitalization; is a congenital anomaly; results in persistent or significant disability/incapacity; is an important medical event requiring medical or surgical intervention to prevent serious outcome. Severity of AEs was categorized as mild, moderate, or severe. Relationship of the AE to the study treatment was categorized as having a reasonable possibility or no reasonable possibility.
Columbia-Suicide Severity Rating Scale (C-SSRS) During Double-Blind Treatment Period Baseline to 20 weeks after last dose of study drug; overall median time on treatment was 279 days. The C-SSRS is a systematically administered instrument developed to track suicidal adverse events across a treatment study. The instrument is designed to assess suicidal behavior and ideation, track and assess all suicidal events, as well as the lethality of attempts. Suicidal ideation categories include the following: wish to be dead; nonspecific active suicidal thoughts; active suicidal ideation without intent to act; active suicidal ideation with some intent to act but no plan; active suicidal ideation with plan and intent. Suicidal behavior categories include the following: actual attempt; interrupted attempt; aborted attempt; preparatory acts or behavior; suicidal behavior; completed suicide.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (57)
Griffith University /ID# 204905
🇦🇺Southport, Queensland, Australia
Hospital Clinic de Barcelona /ID# 204519
🇪🇸Barcelona, Spain
Karolinska University Hospital Huddinge /ID# 203900
🇸🇪Stockholm, Stockholms Lan, Sweden
Parkwood Institute /ID# 204121
🇨🇦London, Ontario, Canada
Fundacio ACE /ID# 204520
🇪🇸Barcelona, Spain
Fundacion CITA Alzheimer Fundazioa /ID# 204521
🇪🇸Donostia, Pais Vasco, Spain
Ucsd /Id# 204001
🇺🇸La Jolla, California, United States
University of Kentucky Chandler Medical Center /ID# 203996
🇺🇸Lexington, Kentucky, United States
North Shore University Hospital /ID# 203994
🇺🇸New Hyde Park, New York, United States
Southern IL Univ School of Med /ID# 203952
🇺🇸Springfield, Illinois, United States
Keystone Clinical Studies LLC /ID# 213183
🇺🇸Plymouth Meeting, Pennsylvania, United States
St Vincent's Centre for Applied Medical Research /ID# 204903
🇦🇺Darlinghurst, New South Wales, Australia
Integrated Neurology Services /ID# 203990
🇺🇸Alexandria, Virginia, United States
Sahlgrenska University Hospital Molndal /ID# 203899
🇸🇪Molndal, Vastra Gotalands Lan, Sweden
Hospital Universitario 12 de Octubre /ID# 204518
🇪🇸Madrid, Spain
Irvine Clinical Research /ID# 204000
🇺🇸Irvine, California, United States
Indiana University /ID# 203989
🇺🇸Indianapolis, Indiana, 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
Emory University / Emory Brain Health Center /ID# 203999
🇺🇸Atlanta, Georgia, United States
Brigham and Women's Physicians /ID# 204003
🇺🇸Boston, Massachusetts, United States
NeuroStudies.net, LLC /ID# 204004
🇺🇸Decatur, Georgia, United States
Advocate Lutheran General Hospital /ID# 203993
🇺🇸Park Ridge, Illinois, United States
Duke Univ Med Ctr /ID# 203958
🇺🇸Durham, North Carolina, United States
Kerwin Research Center /ID# 203998
🇺🇸Dallas, Texas, United States
Vanderbilt Ingram Cancer Center /ID# 203951
🇺🇸Nashville, Tennessee, 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
Azienda Ospedaliera di Perugia /ID# 203905
🇮🇹Perugia, Umbria, Italy
University of Kansas Medical Center - Alzheimer's Disease Center /ID# 203960
🇺🇸Fairway, Kansas, United States
Australian Alzheimer's Res Fou /ID# 204904
🇦🇺Nedlands, Western Australia, Australia
Rigshospitalet /ID# 204591
🇩🇰Copenhagen Ø, Hovedstaden, Denmark
Mayo Clinic /ID# 203995
🇺🇸Jacksonville, Florida, United States
Synexus Clinical Research US, Inc /ID# 204010
🇺🇸The Villages, Florida, United States
Hattiesburg Clinic /ID# 213435
🇺🇸Hattiesburg, Mississippi, United States
Princeton Medical Institute /ID# 203953
🇺🇸Princeton, New Jersey, United States
Austin Health /ID# 204906
🇦🇺Heidelberg, Victoria, Australia
UCL Saint-Luc /ID# 204963
🇧🇪Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium
Universitair Ziekenhuis Leuven /ID# 204965
🇧🇪Leuven, Vlaams-Brabant, Belgium
Groupe Sante CHC - Clinique du MontLegia /ID# 204964
🇧🇪Liege, Belgium
Toronto Memory Program /ID# 204120
🇨🇦Toronto, Ontario, Canada
Clinical Research Services Turku /ID# 205924
🇫🇮Turku, Varsinais-Suomi, 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
IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli /ID# 203903
🇮🇹Brescia, Italy
ASST Grande Ospedale Metropolitano Niguarda /ID# 203901
🇮🇹Milano, Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 203902
🇮🇹Milan, Italy
CGM Research Trust /ID# 204907
🇳🇿Burwood, New Zealand
Massachusetts General Hospital /ID# 203954
🇺🇸Boston, Massachusetts, United States
Banner University of Arizona Medical Center Phoenix /ID# 203959
🇺🇸Phoenix, Arizona, United States
Oregon Health and Science University /ID# 203997
🇺🇸Portland, Oregon, United States
University of South Florida /ID# 204009
🇺🇸Tampa, Florida, United States
Synexus Clinical Research US, Inc. /ID# 203992
🇺🇸Orlando, Florida, United States
Rhode Island Hospital /ID# 204005
🇺🇸Providence, Rhode Island, United States