RecruitingPhase 1 / PHASE2

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

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of ABBV-1758 in Participants With Alzheimer's Disease

Lead sponsor

AbbVie

Asset

ABBV-1758

Listed sites

Recruiting sites

Enrollment

210

estimated

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•Amyloid biomarker required (PET)•MMSE 20•Brain MRI excludes superficial siderosis, vasogenic edema

Primary endpoints

•Adverse Events (AEs)•Clinical Laboratory Test Results•Amyloid-Related Imaging Abnormalities (ARIA)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDM25-804

NCT IDNCT07599670

Timeline

Milestones

Study start2026-05-15actual

Study first posted2026-05-20actual

Last update posted2026-06-23actual

Primary completion2030-04estimated (month precision)

Study completion2030-10estimated (month precision)

Assets

Drug assets

ABBV-1758

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

Maximum age90 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•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 criteria

•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

Endpoints (20)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)

Safety / tolerability / PK

Amyloid biomarkers

Behavior / neuropsychiatric

1 endpoint

Primary/protocol endpoint

Percentage of Participants Experiencing Any Suicidal Ideation or Suicidal Behavior As Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)

Time frame:Up to approximately 40 weeks

threshold achievement, improvement

Amyloid biomarkers

2 endpoints

Primary/protocol endpoint

Percentage of Participants With Amyloid-Related Imaging Abnormalities (ARIA)

Time frame:Up to approximately 40 weeks

threshold achievement, improvement

Primary/protocol endpoint

Stage A, B, and C: Change from Baseline in Brain Amyloid Load

Time frame:Up to approximately 28 Weeks

change from baseline, improvement

Safety / tolerability / PK

7 endpoints

Primary/protocol endpoint

Percentage of Participants Experiencing Adverse Events (AEs)

Time frame:Up to approximately 40 weeks

threshold achievement, event

Primary/protocol endpoint

Percentage of Participants with Abnormal Change From Baseline in Vital Sign Measurements

Time frame:Up to approximately 40 weeks

change from baseline, event

Primary/protocol endpoint

Stage A and C: Maximum Plasma Concentration (Cmax) of ABBV-1758

Time frame:Up to approximately 40 weeks

concentration, descriptive

Primary/protocol endpoint

Stage A and C: Time to Cmax (Tmax) of ABBV-1758

Time frame:Up to approximately 40 weeks

time to event, event

Primary/protocol endpoint

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

Time frame:Up to approximately 40 weeks

concentration, descriptive

Primary/protocol endpoint

Stage A and C: Terminal Phase Elimination Half-Life (t1/2) of ABBV-1758

Time frame:Up to approximately 40 weeks

concentration, descriptive

Primary/protocol endpoint

Stage A and C: Effective Half-Life (T1/2,eff)

Time frame:Up to approximately 40 weeks

concentration, descriptive

Other (unclassified)

10 endpoints

Primary/protocol endpoint/low confidence

Percentage of Participants with Abnormal Change from Baseline in Clinical Laboratory Test Results

Time frame:Up to approximately 40 weeks

change from baseline, improvement

Primary/protocol endpoint/low confidence

Percentage of Participants with Abnormal Change From Baseline in Electrocardiograms (ECGs) Parameters

Time frame:Up to approximately 40 weeks

change from baseline, improvement

Primary/protocol endpoint/low confidence

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

Time frame:Up to approximately 40 weeks

concentration, descriptive

Primary/protocol endpoint/low confidence

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

Time frame:Up to approximately 40 weeks

concentration, descriptive

Primary/protocol endpoint/low confidence

Stage A and C: Accumulation ratio for (AUCtau) of ABBV-1758

Time frame:Up to approximately 40 weeks

ratio, descriptive

Primary/protocol endpoint/low confidence

Stage A and C: Total Body Clearance (CL) of ABBV-1758

Time frame:Up to approximately 40 weeks

categorical status, descriptive

Primary/protocol endpoint/low confidence

Stage A and C: Apparent Clearance (CL/F) of ABBV-1758

Time frame:Up to approximately 40 weeks

categorical status, descriptive

Primary/protocol endpoint/low confidence

Stage A and C: Volume of Distribution at Steady-State (Vss)

Time frame:Up to approximately 40 weeks

categorical status, descriptive

Primary/protocol endpoint/low confidence

Stage A and C: Apparent Volume of Distribution during the Terminal Phase (Vz)

Time frame:Up to approximately 40 weeks

categorical status, descriptive

Primary/protocol endpoint/low confidence

Stage A and C: Terminal Phase Elimination Rate Constant (β) of ABBV-1758

Time frame:Up to approximately 40 weeks

categorical status, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.