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ABBV-1758

Phase 1

Alzheimer's Disease | Small molecule | Neurology |AbbVie Inc.|Last Updated: May 20, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment210
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07599670A 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 DiseasePHASE1 NOT YET_RECRUITING 210May 15, 2026Nov 1, 2030May 20, 2026 -
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Study Endpoints
Primary Endpoints
Number of Participants Experiencing Adverse Events (AEs)
Up to approximately 36 weeks

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
Up to approximately 36 weeks

Number of participants with abnormal change in clinical laboratory test results like hematology will be assessed.

Change From Baseline in amyloid-related imaging abnormalities (ARIA) Measured by Magnetic Resonance Im-aging (MRI)
Up to approximately 36 weeks

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
Up to approximately 36 weeks

Number of participants with abnormal change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed.

Change From Baseline in Electrocardiograms (ECGs)
Up to approximately 36 weeks

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).

Change from Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS)
Up to approximately 36 weeks

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.

Stage A, B, and C: Change from Baseline in Brain Amyloid Plaque Deposition
Up to approximately 28 Weeks

Measured by amyloid positron emission tomography (PET)

Stage A and C: Maximum Plasma Concentration (Cmax) of ABBV-1758
Up to approximately 12 months

Cmax of ABBV-1758

Stage A and C: Time to Cmax (Tmax) of ABBV-1758
Up to approximately 12 months

Tmax of ABBV-1758

Stage A and C: Trough Concentration measured at the end of a dosing interval at steady state (Ctrough) of ABBV-1758
Up to approximately 12 months

Ctrough of ABBV-1758

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
Up to approximately 12 months

AUCtau of ABBV-1758

Stage A and C: Average Serum Concentration at Steady-State (Cav,ss) of ABBV-1758
Up to approximately 12 months

Cav,ss of ABBV-1758

Stage A and C: Accumulation ratio for (AUCtau) of ABBV-1758
Up to approximately 12 months

AUCtau of ABBV-1758

Stage A and C: Total Body Clearance (CL) of ABBV-1758
Up to approximately 12 months

CL of ABBV-1758

Stage A and C: Apparent Clearance (CL/F) of ABBV-1758
Up to approximately 12 months

CL/F of ABBV-1758

Stage A and C: Volume of Distribution at Steady-State (Vss)
Up to approximately 12 months

Vss of ABBV-1758

Stage A and C: Apparent Volume of Distribution during the Terminal Phase (Vz)
Up to approximately 12 months

Vz of ABBV-1758

Stage A and C: Terminal Phase Elimination Rate Constant (β) of ABBV-1758
Up to approximately 12 months

β of ABBV-1758

Stage A and C: Terminal Phase Elimination Half-Life (t1/2) of ABBV-1758
Up to approximately 12 months

Terminal phase elimination half-life of ABBV-1758

Stage A and C: Effective Half-Life (T1/2,eff)
Up to approximately 12 months

T1/2,eff of ABBV-1758

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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Stage A-ABBV-1758 Dose AEXPERIMENTALParticipants will receive ABBV-1758 dose A once every 4 weeks (Q4W).
Stage A-Placebo for ABBV-1758 Dose APLACEBO_COMPARATORParticipants will receive Placebo dose A once every 4 weeks (Q4W).
Stage A-ABBV-1758 Dose BEXPERIMENTALParticipants will receive ABBV-1758 dose B Q4W.
Stage A-Placebo for ABBV-1758 Dose BPLACEBO_COMPARATORParticipants will receive Placebo dose B Q4W.
Stage A-ABBV-1758 Dose CEXPERIMENTALParticipants will receive ABBV-1758 dose C Q4W.
Stage A-Placebo for ABBV-1758 Dose CPLACEBO_COMPARATORParticipants will receive Placebo dose C Q4W.
Stage A-ABBV-1758 Dose DEXPERIMENTALParticipants will receive ABBV-1758 dose D Q4W.
Stage A-Placebo for ABBV-1758 Dose DPLACEBO_COMPARATORParticipants will receive Placebo dose D Q4W.
Stage B- ABBV-1758 - Expanded Cohort 1EXPERIMENTALParticipants will receive ABBV-1758 dose determined in Stage A Q4W.
Stage B- Placebo for ABBV-1758 - Expanded Cohort 1PLACEBO_COMPARATORParticipants will receive Placebo dose determined in Stage A Q4W.
Stage B- ABBV-1758- Expanded Cohort 2EXPERIMENTALParticipants will receive ABBV-1758 dose determined in Stage A Q4W.
Stage B- Placebo for ABBV-1758- Expanded Cohort 2PLACEBO_COMPARATORParticipants will receive Placebo dose determined in Stage A Q4W.
Stage C- ABBV-1758 - Japanese Cohort 1EXPERIMENTALParticipants will receive ABBV-1758 dose determined in Stage A Q4W.
Stage C- Placebo for ABBV-1758 - Japanese Cohort 1PLACEBO_COMPARATORParticipants will receive Placebo dose determined in Stage A Q4W.
Stage C- ABBV-1758- Japanese Cohort 2EXPERIMENTALParticipants will receive ABBV-1758 dose determined in Stage A Q4W.
Stage C- Placebo for ABBV-1758- Japanese Cohort 2PLACEBO_COMPARATORParticipants will receive Placebo dose determined in Stage A Q4W.
Stage C- ABBV-1758-Chinese CohortEXPERIMENTALParticipants will receive ABBV-1758 dose determined in Stage A Q4W.
Stage C- Placebo for ABBV-1758- Chinese CohortPLACEBO_COMPARATORParticipants will receive Placebo dose determined in Stage A Q4W.
Interventions
NameTypeDescription
ABBV-1758DRUGIntravenous (IV) or Subcutaneous (SC)
Placebo for ABBV-1758DRUGIntravenous (IV) or Subcutaneous (SC)
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Eligibility Criteria
Age Range50 Years — 90 Years
SexALL
Healthy VolunteersNo

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 ...

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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT07599670studyFirstPostDate: changed
LOWMay 21, 2026NCT07599670NEW_TRIAL: changed
LOWMay 21, 2026NCT07599670NEW_TRIAL: changed