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
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of ABBV-916 in Subjects With Early Alzheimer's Disease
2 other identifiers
interventional
106
1 country
32
Brief Summary
Alzheimer's disease (AD) is a progressive, irreversible neurological disorder and is the most common cause of dementia in the elderly population. Clinical symptoms of the disease may begin with occasional forgetfulness such as misplacement of items, forgetting important dates or events, and may progress to noticeable memory loss, increased confusion and agitation, and eventually, loss of independence and non-responsiveness. This study will assess how safe and effective ABBV-916 is in treating early AD. Adverse events, change in disease activity, and how ABBV-916 moves through body of participants will be assessed. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2022
Typical duration for phase_2
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 21, 2022
CompletedFirst Posted
Study publicly available on registry
March 22, 2022
CompletedStudy Start
First participant enrolled
August 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 19, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 19, 2025
CompletedDecember 10, 2025
December 1, 2025
3.3 years
March 21, 2022
December 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (10)
Number of Participants Experiencing Adverse Events (AEs)
An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.
Up to approximately 160 weeks
Stage A: Maximum Observed Serum Concentration (Cmax) for Multiple Ascending Dose of ABBV-916
Cmax of ABBV-916 will be determined.
Up to approximately 24 weeks
Stage A: Time to Cmax (Tmax) for Multiple Ascending Dose of ABBV-916
Tmax of ABBV-916 will be determined.
Up to approximately 24 weeks
Stage A: Apparent Terminal Phase Elimination Rate Constant (β) of ABBV-916
Apparent terminal phase elimination rate constant (β) of ABBV-916 will be determined.
Up to approximately 24 weeks
Stage A: Terminal Phase Elimination Half-Life (t1/2) of ABBV-916
T1/2 of ABBV-916 will be determined.
Up to approximately 24 weeks
Stage A: Trough Serum Concentration (Ctrough) of ABBV-916 at the End of a Dosing Interval
Ctrough of ABBV-916 will be determined.
Up to approximately 24 weeks
Stage A: Area Under the Concentration-Time Curve (AUC) of ABBV-916
AUC of ABBV-916 will be determined.
Up to approximately 24 weeks
Stage A: Cerebrospinal Fluid (CSF) Concentration as a Measure of ABBV-916 Crossing the Blood Brain Barrier
The central value for ratio of ABBV-916 concentration in cerebrospinal fluid (CSF) to that in serum will be estimated for evaluation of the fraction of ABBV-916 crossing the blood brain barrier.
Up to approximately 24 weeks
Stage A: Percentage of Participants With Antidrug Antibodies (ADA) as a Measure of Immunogenicity Following Multiple Ascending Dose of ABBV-916
Antidrug antibody (ADA) classification and titers for positive ADA samples will be determined.
Up to approximately 24 weeks
Stage B: Change in Brain Amyloid Plaque Deposition (Amyloid Centiloid Value)
Change from baseline in brain amyloid plaque deposition (amyloid centiloid value) is measured by amyloid positron emission tomography (PET) scan.
Baseline (Week 0) through Week 24
Study Arms (5)
Stage A: ABBV-916
EXPERIMENTALParticipants 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.
Stage A: Placebo for ABBV-916
PLACEBO COMPARATORParticipants 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.
Stage B: ABBV-916 Dose A
EXPERIMENTALParticipants 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.
Stage B: Placebo for ABBV-916
PLACEBO COMPARATORParticipants 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.
Stage B: ABBV-916 Dose B
EXPERIMENTALParticipants 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.
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of Stage 3 or Stage 4 Alzheimer's disease (AD) based on the 2018 National Institute on Aging (NIA)-Alzheimer's Association (AA) Research Framework 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.
You may not qualify if:
- Significant pathological findings on brain MRI at screening including, but not limited to, evidence of vasogenic edema, 4 or more microhemorrhages, any macrohemorrhages, any superficial siderosis, or severe white matter disease.
- Any anticoagulants or have a bleeding disorder that is not adequately controlled.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (32)
Tucson Neuroscience Research /ID# 244957
Tucson, Arizona, 85710-6152, United States
Irvine Clinical Research /ID# 239469
Irvine, California, 92614, United States
Artemis Institute for Clinical Research - San Diego /ID# 244508
San Diego, California, 92103-2204, United States
Pacific Research Network, Inc. /ID# 244083
San Diego, California, 92103, United States
Syrentis Clinical Research /ID# 239682
Santa Ana, California, 92705, United States
Aventura Neurological Associates /ID# 243892
Aventura, Florida, 33180, United States
Charter Research - Lady Lake /ID# 244657
Lady Lake, Florida, 32162, United States
JEM Research Institute /ID# 239122
Lake Worth, Florida, 33462-1141, United States
ClinCloud - Maitland /ID# 244507
Maitland, Florida, 32751, United States
ClinCloud LLC - Viera/Melbourne /ID# 240635
Melbourne, Florida, 32940-8288, United States
Merritt Island Medical Research /ID# 239495
Merritt Island, Florida, 32952-3616, United States
Optimus U /ID# 245868
Miami, Florida, 33125-4013, United States
Finlay Medical Research /ID# 245996
Miami, Florida, 33126, United States
Allied Biomedical Res Inst Inc /ID# 244823
Miami, Florida, 33155, United States
Renstar Medical Research /ID# 240153
Ocala, Florida, 34470, United States
K2 Medical Research - Ocoee /ID# 246849
Ocoee, Florida, 34761-4547, United States
K2 Medical Research - Orlando - South Orlando Avenue /ID# 243919
Orlando, Florida, 32751, United States
Charter Research - Winter Park /ID# 244778
Orlando, Florida, 32803-1839, United States
Headlands Research - Orlando /ID# 239119
Orlando, Florida, 32819, United States
Neurology Associates Ormond Beach /ID# 245527
Ormond Beach, Florida, 32174, United States
IMIC Inc. Medical Research /ID# 245900
Palmetto Bay, Florida, 33157, United States
Alzheimer's Research and Treatment Center - Stuart /ID# 245477
Stuart, Florida, 34997-5765, United States
Alzheimer's Research and Treatment Center - Wellington /ID# 245201
Wellington, Florida, 33414, United States
Premiere Research Institute - Palm Beach /ID# 240108
West Palm Beach, Florida, 33407-3209, United States
Clinical Site Partners (CSP) - Orlando /ID# 245127
Winter Park, Florida, 32789-4681, United States
Conquest Research /ID# 243916
Winter Park, Florida, 32789, United States
Columbus Memory Center /ID# 245054
Columbus, Georgia, 31909, United States
QUEST Research Institute /ID# 239459
Farmington Hills, Michigan, 48334-2977, United States
Advanced Memory Research Institute of NJ /ID# 239533
Toms River, New Jersey, 08755-5043, United States
Keystone Clinical Studies LLC /ID# 239973
Plymouth Meeting, Pennsylvania, 19462, United States
Clinical Trials of Texas, Inc /ID# 244917
San Antonio, Texas, 78229, United States
Re:Cognition Health - Fairfax VA /ID# 239501
Fairfax, Virginia, 22031-5207, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 21, 2022
First Posted
March 22, 2022
Study Start
August 15, 2022
Primary Completion
November 19, 2025
Study Completion
November 19, 2025
Last Updated
December 10, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
- Access Criteria
- To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.