Back to search results
NCT07599670

A Study to Assess the Safety and Effects of ABBV-1758 Following Subcutaneous or Intravenous Injections in Participants With Alzheimer's Disease

Recruiting
PHASE1Ages 50–90InterventionalTreatment
AbbVie
~210 participants
Updated 2026-06-23 on ClinicalTrials.gov
What's tested:ABBV-1758Placebo for ABBV-1758

At a glance

Recruiting sites
11 of 11 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of Participants Experiencing Adverse Events (AEs)
Measured over Up to approximately 40 weeks
+19 more outcomes measured

Conditions

Alzheimer's Disease

Explore related trials

Alzheimer's Disease

Where it's being run

11 sites across 6 states
Florida6
California1
Colorado1
Massachusetts1
Tennessee1
Texas1

Study leadership

  • ABBVIE INC. · STUDY_DIRECTOR · AbbVie

Who to contact

ABBVIE CALL CENTER
[email protected]
844-663-3742
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Participants meeting all the following criteria for Alzheimer's disease (AD):
In regions where timely testing is feasible (e.g., results available within 4 weeks of Visit 1), plasma biomarker that is predictive of elevated brain amyloid at Screening for participants that do not have known elevated brain amyloid based on previous amyloid positron emission tomography (PET) results.
Participants with amyloid positron emission tomography PET scan results consistent with significant amyloid pathology (as determined by a Centiloid value of 50 or higher).
Participants must have a Mini-Mental State Examination (MMSE) score of 20 or higher at Screening.

Exclusion

Participants with screening magnetic resonance imaging (MRI) that show evidence of another potential etiology for progressive dementia.
Participants who have any current serious conditions or illnesses that are not adequately controlled, or any conditions that, in the investigator's opinion, could interfere with the analyses in this study, including but not limited to psychiatric, neurologic (other than AD), cardiovascular, hepatic, renal, gastroenterological, respiratory, endocrinologic, immunologic, or hematologic, metabolic, pulmonary, ophthalmologic, dermatologic, and/or any history of abnormal laboratory results that are indicative of significant disease(s).
Participants who had prior exposure to ABBV-1758 or any history of exposure to anti-amyloid beta monoclonal antibody (mAb) treatment.
Participants with other significant pathological findings on brain MRI at screening, including but not limited to:
Evidence of vasogenic edema
4 or more microhemorrhages (defined as 10 mm or less at the greatest diameter)
Any macrohemorrhage (defined as greater than 10 mm at the greatest diameter)
Any superficial siderosis
Severe white matter disease

What this trial measures

  • Percentage of Participants Experiencing Adverse Events (AEs)Up to approximately 40 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.

  • Percentage of Participants with Abnormal Change from Baseline in Clinical Laboratory Test ResultsUp to approximately 40 weeks

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

  • Percentage of Participants With Amyloid-Related Imaging Abnormalities (ARIA)Up to approximately 40 weeks

    Amyloid related imaging abnormalities represent a spectrum of magnetic resonance imaging findings primarily observed in participants undergoing treatment with anti-amyloid therapies.

  • Percentage of Participants with Abnormal Change From Baseline in Vital Sign MeasurementsUp to approximately 40 weeks

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

  • Percentage of Participants with Abnormal Change From Baseline in Electrocardiograms (ECGs) ParametersUp to approximately 40 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).

  • Percentage of Participants Experiencing Any Suicidal Ideation or Suicidal Behavior As Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)Up to approximately 40 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 LoadUp to approximately 28 Weeks

    Measured by amyloid positron emission tomography (PET)

  • Stage A and C: Maximum Plasma Concentration (Cmax) of ABBV-1758Up to approximately 40 weeks

    Cmax of ABBV-1758

  • Stage A and C: Time to Cmax (Tmax) of ABBV-1758Up to approximately 40 weeks

    Tmax of ABBV-1758

  • Stage A and C: Trough Concentration measured at the end of a dosing interval at steady state (Ctrough) of ABBV-1758Up to approximately 40 weeks

    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-1758Up to approximately 40 weeks

    AUCtau of ABBV-1758

  • Stage A and C: Average Serum Concentration at Steady-State (Cav,ss) of ABBV-1758Up to approximately 40 weeks

    Cav,ss of ABBV-1758

  • Stage A and C: Accumulation ratio for (AUCtau) of ABBV-1758Up to approximately 40 weeks

    AUCtau of ABBV-1758

  • Stage A and C: Total Body Clearance (CL) of ABBV-1758Up to approximately 40 weeks

    CL of ABBV-1758

  • Stage A and C: Apparent Clearance (CL/F) of ABBV-1758Up to approximately 40 weeks

    CL/F of ABBV-1758

  • Stage A and C: Volume of Distribution at Steady-State (Vss)Up to approximately 40 weeks

    Vss of ABBV-1758

  • Stage A and C: Apparent Volume of Distribution during the Terminal Phase (Vz)Up to approximately 40 weeks

    Vz of ABBV-1758

  • Stage A and C: Terminal Phase Elimination Rate Constant (β) of ABBV-1758Up to approximately 40 weeks

    β of ABBV-1758

  • Stage A and C: Terminal Phase Elimination Half-Life (t1/2) of ABBV-1758Up to approximately 40 weeks

    Terminal phase elimination half-life of ABBV-1758

  • Stage A and C: Effective Half-Life (T1/2,eff)Up to approximately 40 weeks

    T1/2,eff of ABBV-1758