A Study to Assess the Safety and Effects of ABBV-1758 Following Subcutaneous or Intravenous Injections in Participants With Alzheimer's Disease
← catalyst calendarNCT07599670 · readout ≤ 1,350 d
Sponsored by AbbVie (industry) · ABBV — their whole pipeline →.
Phase
Phase 1/2
Status
Recruiting
Study type
Interventional
Design
Randomized · Triple · Treatment
Enrollment
210estimated
Sites
11
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 | 2026-05-15 | actual | When the study began enrolling |
| Primary completion | Apr 2030 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Oct 2030 | estimated | The whole study's end, after follow-up |
| First posted | 2026-05-20 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-14 | 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
Interventions
- Drug: ABBV-1758
- Drug: Placebo for ABBV-1758
- Drug: ABBV-1758
- Drug: Placebo for ABBV-1758
Primary outcomes
what the primary-completion date above is the date OFPercentage of Participants Experiencing Adverse Events (AEs)
measured Up to approximately 40 weeks
Percentage of Participants with Abnormal Change from Baseline in Clinical Laboratory Test Results
measured Up to approximately 40 weeks
Percentage of Participants With Amyloid-Related Imaging Abnormalities (ARIA)
measured Up to approximately 40 weeks
Percentage of Participants with Abnormal Change From Baseline in Vital Sign Measurements
measured Up to approximately 40 weeks
Percentage of Participants with Abnormal Change From Baseline in Electrocardiograms (ECGs) Parameters
measured Up to approximately 40 weeks
Percentage of Participants Experiencing Any Suicidal Ideation or Suicidal Behavior As Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)
measured Up to approximately 40 weeks
Stage A, B, and C: Change from Baseline in Brain Amyloid Load
measured Up to approximately 28 Weeks
Stage A and C: Maximum Plasma Concentration (Cmax) of ABBV-1758
measured Up to approximately 40 weeks
Stage A and C: Time to Cmax (Tmax) of ABBV-1758
measured Up to approximately 40 weeks
Stage A and C: Trough Concentration measured at the end of a dosing interval at steady state (Ctrough) of ABBV-1758
measured Up to approximately 40 weeks
Stage A and C: Area under the Plasma Concentration-time Curve from Time Zero to the End of the Dosing Interval (AUCtau) of ABBV-1758
measured Up to approximately 40 weeks
Stage A and C: Average Serum Concentration at Steady-State (Cav,ss) of ABBV-1758
measured Up to approximately 40 weeks
Stage A and C: Accumulation ratio for (AUCtau) of ABBV-1758
measured Up to approximately 40 weeks
Stage A and C: Total Body Clearance (CL) of ABBV-1758
measured Up to approximately 40 weeks
Stage A and C: Apparent Clearance (CL/F) of ABBV-1758
measured Up to approximately 40 weeks
Stage A and C: Volume of Distribution at Steady-State (Vss)
measured Up to approximately 40 weeks
Stage A and C: Apparent Volume of Distribution during the Terminal Phase (Vz)
measured Up to approximately 40 weeks
Stage A and C: Terminal Phase Elimination Rate Constant (β) of ABBV-1758
measured Up to approximately 40 weeks
Stage A and C: Terminal Phase Elimination Half-Life (t1/2) of ABBV-1758
measured Up to approximately 40 weeks
Stage A and C: Effective Half-Life (T1/2,eff)
measured Up to approximately 40 weeks
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