A Study to Evaluate the Efficacy and Safety of ABBV-8E12 in Participants With Early Alzheimer's Disease
NCT ID: NCT02880956
Last Updated: 2022-08-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
453 participants
INTERVENTIONAL
2017-01-26
2021-07-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Placebo for ABBV-8E12 every 4 weeks for 96 weeks
placebo for ABBV-8E12
placebo solution for intravenous (IV) infusion
ABBV-8E12 300 mg
ABBV-8E12 300 mg every 4 weeks for 96 weeks
ABBV-8E12
ABBV-8E12 solution for IV infusion
ABBV-8E12 1000 mg
ABBV-8E12 1000 mg every 4 weeks for 96 weeks
ABBV-8E12
ABBV-8E12 solution for IV infusion
ABBV-8E12 2000 mg
ABBV-8E12 2000 mg every 4 weeks for 96 weeks
ABBV-8E12
ABBV-8E12 solution for IV infusion
Interventions
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ABBV-8E12
ABBV-8E12 solution for IV infusion
placebo for ABBV-8E12
placebo solution for intravenous (IV) infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Clinical Dementia Rating (CDR)-Global Score of 0.5
* Mini-Mental State Examination (MMSE) score of 22 to 30, inclusive
* Repeatable Battery for the Assessment of Neuropsychological Status-Delayed Memory Index (RBANS - DMI) score of 85 or lower
* Subject has a positive amyloid positron emission tomography (PET) scan.
* Subject has a Modified Hachinski Ischemic Scale (MHIS) score of ≤ 4.
* The subject has an identified, reliable, study partner (e.g., family member).
* If using medications to treat symptoms related to AD, doses must be stable for at least 12 weeks prior to randomization.
Exclusion Criteria
* Subject has evidence of any other clinically significant neurological disorder other than early AD.
* In the opinion of the investigator, the subject has any clinically significant or uncontrolled medical or psychiatric illness, or has had an infection requiring medical intervention in the past 30 days.
* Subject has had a myocardial infarction, unstable angina, stroke, transient ischemic attack or required intervention for any of these conditions within 6 months of Screening.
55 Years
85 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# 151536
Phoenix, Arizona, United States
Banner Sun Health Res Inst /ID# 151895
Sun City, Arizona, United States
Irvine Clinical Research /ID# 162331
Irvine, California, United States
Ucsd /Id# 152467
La Jolla, California, United States
Ray Dolby Brain Health Center /ID# 154965
San Francisco, California, United States
Univ California, San Francisco /ID# 152053
San Francisco, California, United States
Brain Matters Research /ID# 147796
Delray Beach, Florida, United States
Neuropsychiatric Research Center of Southwest Florida /ID# 162332
Fort Myers, Florida, United States
Mayo Clinic /ID# 151236
Jacksonville, Florida, United States
Synexus Clinical Research US, Inc. /ID# 147804
Orlando, Florida, United States
University of South Florida /ID# 151890
Tampa, Florida, United States
Synexus Clinical Research US, Inc /ID# 151633
The Villages, Florida, United States
Emory Midtown Infectious Disease Clinic /ID# 151492
Atlanta, Georgia, United States
Atlanta Center for Medical Research /ID# 151550
Atlanta, Georgia, United States
NeuroStudies.net, LLC /ID# 152746
Decatur, Georgia, United States
Great Lakes Clinical Trials /ID# 152754
Chicago, Illinois, United States
Advocate Lutheran General Hospital /ID# 152052
Park Ridge, Illinois, United States
Southern IL Univ School of Med /ID# 151769
Springfield, Illinois, United States
Indiana University /ID# 151861
Indianapolis, Indiana, United States
University of Kansas Medical Center - Alzheimer's Disease Center /ID# 151554
Fairway, Kansas, United States
University of Kentucky Chandler Medical Center /ID# 152753
Lexington, Kentucky, United States
Johns Hopkins Bayview Med Cnt /ID# 151893
Baltimore, Maryland, United States
Massachusetts General Hospital /ID# 151770
Boston, Massachusetts, United States
Brigham and Women's Physicians /ID# 151882
Boston, Massachusetts, United States
Hattiesburg Clinic /ID# 202388
Hattiesburg, Mississippi, United States
Princeton Medical Institute /ID# 152934
Princeton, New Jersey, United States
Scott Research Inc. /ID# 151880
Laurelton, New York, United States
North Shore University Hospital /ID# 151632
New Hyde Park, New York, United States
Duke Cancer Center /ID# 147828
Durham, North Carolina, United States
Oregon Health and Science University /ID# 151690
Portland, Oregon, United States
Keystone Clinical Studies LLC /ID# 202305
Plymouth Meeting, Pennsylvania, United States
Rhode Island Hospital /ID# 151538
Providence, Rhode Island, United States
Vanderbilt University Medical Center /ID# 154547
Nashville, Tennessee, United States
Kerwin Research Center /ID# 147815
Dallas, Texas, United States
Houston Methodist Hospital /ID# 154810
Houston, Texas, United States
McGovern Medical School /ID# 204860
Houston, Texas, United States
University of Utah /ID# 151858
Salt Lake City, Utah, United States
Integrated Neurology Services /ID# 154863
Alexandria, Virginia, United States
The Kinghorn Cancer Centre /ID# 152632
Darlinghurst, New South Wales, Australia
Griffith University /ID# 152635
Southport, Queensland, Australia
Austin Health /ID# 152637
Heidelberg, Victoria, Australia
The Royal Melbourne Hospital /ID# 202633
Parkville, Victoria, Australia
Australian Alzheimer's Res Fou /ID# 152634
Nedlands, Western Australia, Australia
Neurodegenerative Disorders Research /ID# 152826
West Perth, Western Australia, Australia
UCL Saint-Luc /ID# 152847
Woluwe-Saint-Lambert, Brussels Capital, Belgium
Universitair Ziekenhuis Leuven /ID# 152642
Leuven, Vlaams-Brabant, Belgium
Groupe Sante CHC - Clinique du MontLegia /ID# 152846
Liège, , Belgium
Parkwood Institute /ID# 164204
London, Ontario, Canada
Toronto Memory Program /ID# 147863
Toronto, Ontario, Canada
Rigshospitalet /ID# 153192
Copenhagen Ø, Capital Region, Denmark
Clinical Research Services Turku /ID# 152845
Turku, Southwest Finland, Finland
Ita-Suomen Yliopisto /ID# 152959
Kuopio, , Finland
AOU di Modena /ID# 152394
Modena, Emilia-Romagna, Italy
Policlinico Agostino Gemelli /ID# 152396
Rome, Lazio, Italy
Duplicate_AOU Policlinico Umberto I /ID# 163144
Rome, Lazio, Italy
Azienda Ospedaliera di Perugia /ID# 152397
Perugia, Umbria, Italy
IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli /ID# 152395
Brescia, , Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 152401
Milan, , Italy
ASST Grande Ospedale Metropolitano Niguarda /ID# 152391
Milan, , Italy
Universitair Medisch Centrum Utrecht /ID# 163576
Utrecht, , Netherlands
CGM Research Trust /ID# 152827
Burwood, , New Zealand
Fundacion CITA Alzheimer Fundazioa /ID# 152645
Donostia / San Sebastian, Basque Country, Spain
Fundacio ACE /ID# 152643
Barcelona, , Spain
Hospital Clinic de Barcelona /ID# 152646
Barcelona, , Spain
Hospital Clinico Universitario San Carlos /ID# 153703
Madrid, , Spain
Hospital Universitario 12 de Octubre /ID# 152647
Madrid, , Spain
Karolinska University Hospital Huddinge /ID# 156705
Stockholm, Stockholm County, Sweden
Sahlgrenska University Hospital Molndal /ID# 154465
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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2016-001634-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M15-566
Identifier Type: -
Identifier Source: org_study_id
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