| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07599670 | A Study to Assess the Adverse Events, Change in Disease Activity, and How Intravenous ABBV-1758 Moves Through the Body of Adult Participants With Alzheimer's Disease | PHASE1 | NOT YET_RECRUITING | 210 | — | — | May 15, 2026 | Nov 1, 2030 | May 20, 2026 | - | — |
An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with the treatment. The investigator assesses the relationship of each event to the use of study drug.
Number of participants with abnormal change in clinical laboratory test results like hematology will be assessed.
Magnetic resonance imaging (MRI) of several different brain regions was per-formed, and volumetric analysis was con-ducted to quantify midbrain atrophy. Negative changes in values indicate a re-duction in volume.
Number of participants with abnormal change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed.
12-lead resting ECGs will be recorded. Parameters include heart rate, PR interval, QT interval, QRS duration, and QT interval corrected using Fridericia's formula (QTcF).
The C-SSRS is a clinician-rated instrument that reports the severity of both suicidal ideation and behavior, with a higher score denoting more severe suicidal ideation and behavior.
Measured by amyloid positron emission tomography (PET)
Cmax of ABBV-1758
Tmax of ABBV-1758
Ctrough of ABBV-1758
AUCtau of ABBV-1758
Cav,ss of ABBV-1758
AUCtau of ABBV-1758
CL of ABBV-1758
CL/F of ABBV-1758
Vss of ABBV-1758
Vz of ABBV-1758
β of ABBV-1758
Terminal phase elimination half-life of ABBV-1758
T1/2,eff of ABBV-1758
| Arm | Type | Description |
|---|---|---|
| Stage A-ABBV-1758 Dose A | EXPERIMENTAL | Participants will receive ABBV-1758 dose A once every 4 weeks (Q4W). |
| Stage A-Placebo for ABBV-1758 Dose A | PLACEBO_COMPARATOR | Participants will receive Placebo dose A once every 4 weeks (Q4W). |
| Stage A-ABBV-1758 Dose B | EXPERIMENTAL | Participants will receive ABBV-1758 dose B Q4W. |
| Stage A-Placebo for ABBV-1758 Dose B | PLACEBO_COMPARATOR | Participants will receive Placebo dose B Q4W. |
| Stage A-ABBV-1758 Dose C | EXPERIMENTAL | Participants will receive ABBV-1758 dose C Q4W. |
| Stage A-Placebo for ABBV-1758 Dose C | PLACEBO_COMPARATOR | Participants will receive Placebo dose C Q4W. |
| Stage A-ABBV-1758 Dose D | EXPERIMENTAL | Participants will receive ABBV-1758 dose D Q4W. |
| Stage A-Placebo for ABBV-1758 Dose D | PLACEBO_COMPARATOR | Participants will receive Placebo dose D Q4W. |
| Stage B- ABBV-1758 - Expanded Cohort 1 | EXPERIMENTAL | Participants will receive ABBV-1758 dose determined in Stage A Q4W. |
| Stage B- Placebo for ABBV-1758 - Expanded Cohort 1 | PLACEBO_COMPARATOR | Participants will receive Placebo dose determined in Stage A Q4W. |
| Stage B- ABBV-1758- Expanded Cohort 2 | EXPERIMENTAL | Participants will receive ABBV-1758 dose determined in Stage A Q4W. |
| Stage B- Placebo for ABBV-1758- Expanded Cohort 2 | PLACEBO_COMPARATOR | Participants will receive Placebo dose determined in Stage A Q4W. |
| Stage C- ABBV-1758 - Japanese Cohort 1 | EXPERIMENTAL | Participants will receive ABBV-1758 dose determined in Stage A Q4W. |
| Stage C- Placebo for ABBV-1758 - Japanese Cohort 1 | PLACEBO_COMPARATOR | Participants will receive Placebo dose determined in Stage A Q4W. |
| Stage C- ABBV-1758- Japanese Cohort 2 | EXPERIMENTAL | Participants will receive ABBV-1758 dose determined in Stage A Q4W. |
| Stage C- Placebo for ABBV-1758- Japanese Cohort 2 | PLACEBO_COMPARATOR | Participants will receive Placebo dose determined in Stage A Q4W. |
| Stage C- ABBV-1758-Chinese Cohort | EXPERIMENTAL | Participants will receive ABBV-1758 dose determined in Stage A Q4W. |
| Stage C- Placebo for ABBV-1758- Chinese Cohort | PLACEBO_COMPARATOR | Participants will receive Placebo dose determined in Stage A Q4W. |
| Name | Type | Description |
|---|---|---|
| ABBV-1758 | DRUG | Intravenous (IV) or Subcutaneous (SC) |
| Placebo for ABBV-1758 | DRUG | Intravenous (IV) or Subcutaneous (SC) |
Inclusion Criteria: * Participants meeting all the following criteria for Alzheimer's disease (AD): * Plasma pTau217/Aβ42 ratio that is predictive of elevated brain amyloid at Screening. * Participants with amyloid positron emission tomography (PET) scan results consistent with significant amyloid ...