A Study to Assess Safety of ABBV-916 and How Intravenous ABBV-916 Moves Through Body and Affects Brain Amyloid Plaque Clearance in Adult Participants (Aged 50-90 Years) With Early Alzheimer's Disease
NCT ID: NCT05291234
Last Updated: 2025-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
106 participants
INTERVENTIONAL
2022-08-15
2025-11-19
Brief Summary
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ABBV-916 is an investigational drug being developed for the treatment of early AD. This study is conducted in 2 stages. Stage A is a multiple ascending dose study. There is a 1 in 4 chance that participants are assigned to receive placebo. Stage B is a proof-of-concept study. In Stage B, there is a 1 in 5 chance that participants will be assigned to receive placebo. The first 6 months of this study are "double-blind," which means that neither the trial participant nor the study doctors know which treatments will be given. This will be followed by a 2-year extension period in which all participants will receive ABBV-916. Approximately 195 participants aged 50-90 years will be enrolled in about 90 sites across the world.
Participants will receive intravenous (IV) doses of ABBV-916 or placebo once every 4 weeks (Q4W) for 24 weeks and will be followed for an additional 16 weeks. Participants will have the option of participating in a 2-year, open-label, Extension Period receiving IV ABBV-916.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, magnetic resonance imaging (MRI), blood tests, checking for side effects and completing questionnaires.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
QUADRUPLE
Study Groups
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Stage B: ABBV-916 Dose B
Participants will receive ABBV-916 Dose B for 24 weeks. Participants at the end of 24 weeks will have the option of participating in the 2-year Extension Period.
ABBV-916
Intravenous administration
Stage A: ABBV-916
Participants will receive ABBV-916 for 24 weeks. Participants at the end of 24 weeks will have the option of participating in the 2-year Extension Period.
ABBV-916
Intravenous administration
Stage A: Placebo for ABBV-916
Participants will receive Placebo for 24 weeks. Participants at the end of 24 weeks will have the option of participating in the 2-year Extension Period.
Placebo
Intravenous administration
Stage B: ABBV-916 Dose A
Participants will receive ABBV-916 Dose A for 24 weeks. Participants at the end of 24 weeks will have the option of participating in the 2-year Extension Period.
ABBV-916
Intravenous administration
Stage B: Placebo for ABBV-916
Participants will receive Placebo for 24 weeks. Participants at the end of 24 weeks will have the option of participating in the 2-year Extension Period.
Placebo
Intravenous administration
Interventions
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ABBV-916
Intravenous administration
Placebo
Intravenous administration
Eligibility Criteria
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Inclusion Criteria
* Mini-Mental State Examination (MMSE) score of 20 to 28, inclusive, at Screening.
* Blood-based biomarker results with a value consistent with amyloid positron emission tomography (PET) positivity. The biomarker will be chosen by the sponsor and described in the Laboratory Manual. Biomarker results will not be required for eligibility if the participant has a positive Amyloid PET scan meeting the central reader criteria.
* Amyloid PET scan results consistent with amyloid pathology.
* Stage B: Participants must have a study partner who spends a minimum average of 10 hours per week with the participant.
Exclusion Criteria
* Any anticoagulants or have a bleeding disorder that is not adequately controlled.
50 Years
90 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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Tucson Neuroscience Research /ID# 244957
Tucson, Arizona, United States
Irvine Clinical Research /ID# 239469
Irvine, California, United States
Artemis Institute for Clinical Research - San Diego /ID# 244508
San Diego, California, United States
Pacific Research Network, Inc. /ID# 244083
San Diego, California, United States
Syrentis Clinical Research /ID# 239682
Santa Ana, California, United States
Aventura Neurological Associates /ID# 243892
Aventura, Florida, United States
Charter Research - Lady Lake /ID# 244657
Lady Lake, Florida, United States
JEM Research Institute /ID# 239122
Lake Worth, Florida, United States
ClinCloud - Maitland /ID# 244507
Maitland, Florida, United States
ClinCloud LLC - Viera/Melbourne /ID# 240635
Melbourne, Florida, United States
Merritt Island Medical Research /ID# 239495
Merritt Island, Florida, United States
Optimus U /ID# 245868
Miami, Florida, United States
Finlay Medical Research /ID# 245996
Miami, Florida, United States
Allied Biomedical Res Inst Inc /ID# 244823
Miami, Florida, United States
Renstar Medical Research /ID# 240153
Ocala, Florida, United States
K2 Medical Research - Ocoee /ID# 246849
Ocoee, Florida, United States
K2 Medical Research - Orlando - South Orlando Avenue /ID# 243919
Orlando, Florida, United States
Charter Research - Winter Park /ID# 244778
Orlando, Florida, United States
Headlands Research - Orlando /ID# 239119
Orlando, Florida, United States
Neurology Associates Ormond Beach /ID# 245527
Ormond Beach, Florida, United States
IMIC Inc. Medical Research /ID# 245900
Palmetto Bay, Florida, United States
Alzheimer's Research and Treatment Center - Stuart /ID# 245477
Stuart, Florida, United States
Alzheimer's Research and Treatment Center - Wellington /ID# 245201
Wellington, Florida, United States
Premiere Research Institute - Palm Beach /ID# 240108
West Palm Beach, Florida, United States
Clinical Site Partners (CSP) - Orlando /ID# 245127
Winter Park, Florida, United States
Conquest Research /ID# 243916
Winter Park, Florida, United States
Columbus Memory Center /ID# 245054
Columbus, Georgia, United States
QUEST Research Institute /ID# 239459
Farmington Hills, Michigan, United States
Advanced Memory Research Institute of NJ /ID# 239533
Toms River, New Jersey, United States
Keystone Clinical Studies LLC /ID# 239973
Plymouth Meeting, Pennsylvania, United States
Clinical Trials of Texas, Inc /ID# 244917
San Antonio, Texas, United States
Re:Cognition Health - Fairfax VA /ID# 239501
Fairfax, Virginia, United States
Countries
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Related Links
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Other Identifiers
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2022-500691-59-00
Identifier Type: OTHER
Identifier Source: secondary_id
M22-721
Identifier Type: -
Identifier Source: org_study_id
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