A Phase 2 interventional study of ABBV-916 and Placebo in Alzheimer's Disease (AD), sponsored by AbbVie. Completed at 32 sites in United States. Open to participants aged 50 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-12-10.
Sponsored by AbbVie · Phase 2, Interventional, and Treatment
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.
3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.
This study's enrollment of 106 is above the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.
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Of its 350 completed or terminated interventional studies of FDA-regulated products, 210 (60%) have results posted.
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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.
Exclusion Criteria:
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.
Drug: 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.
Drug: Placebo
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.
Drug: 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.
Drug: Placebo
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.
Drug: ABBV-916
Intravenous administration
Intravenous administration
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to approximately 24 weeks
Stage A: Area Under the Concentration-Time Curve (AUC) of ABBV-916
AUC of ABBV-916 will be determined.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline (Week 0) through Week 24
Plan to share: Yes — 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.
Supporting information: Study protocol, Sap
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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