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
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Phase
Phase 2
Status
Completed
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
106actual
Sites
32
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2022-08-15 | actual | When the study began enrolling |
| Primary completion | 2025-11-19 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-11-19 | actual | The whole study's end, after follow-up |
| First posted | 2022-03-22 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-12-10 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Alzheimer's Disease (AD)
Interventions
- Drug: ABBV-916
- Drug: Placebo
Primary outcomes
what the primary-completion date above is the date OFNumber of Participants Experiencing Adverse Events (AEs)
measured Up to approximately 160 weeks
Stage A: Maximum Observed Serum Concentration (Cmax) for Multiple Ascending Dose of ABBV-916
measured Up to approximately 24 weeks
Stage A: Time to Cmax (Tmax) for Multiple Ascending Dose of ABBV-916
measured Up to approximately 24 weeks
Stage A: Apparent Terminal Phase Elimination Rate Constant (β) of ABBV-916
measured Up to approximately 24 weeks
Stage A: Terminal Phase Elimination Half-Life (t1/2) of ABBV-916
measured Up to approximately 24 weeks
Stage A: Trough Serum Concentration (Ctrough) of ABBV-916 at the End of a Dosing Interval
measured Up to approximately 24 weeks
Stage A: Area Under the Concentration-Time Curve (AUC) of ABBV-916
measured Up to approximately 24 weeks
Stage A: Cerebrospinal Fluid (CSF) Concentration as a Measure of ABBV-916 Crossing the Blood Brain Barrier
measured 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
measured Up to approximately 24 weeks
Stage B: Change in Brain Amyloid Plaque Deposition (Amyloid Centiloid Value)
measured Baseline (Week 0) through Week 24
Publications
- PMID 42565245 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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