CompletedPhase 2

A Study to Assess Safety of ABBV-916 and How Intravenous ABBV-916 Moves Through Body and Affects Brain Amyloid Plaque Clearance in Adult Participants (Aged 50-90 Years) With Early Alzheimer's Disease

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of ABBV-916 in Subjects With Early Alzheimer's Disease

Lead sponsor

AbbVie

Asset

ABBV-916

Listed sites

Recruiting sites

Enrollment

106

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•Amyloid biomarker required (PET/plasma)•MMSE 20-28•Study partner/caregiver required•Brain MRI excludes superficial siderosis, vasogenic edema

Primary endpoints

•Adverse Events (AEs)•Stage•Amyloid PET Centiloid

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

Secondary ID2022-500691-59-00EU CT

Org study IDM22-721

NCT IDNCT05291234

Timeline

Milestones

Study first posted2022-03-22actual

Study start2022-08-15actual

Primary completion2025-11-19actual

Study completion2025-11-19actual

Last update posted2025-12-10actual

Assets

Drug assets

ABBV-916

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

•Diagnosis of Stage 3 or Stage 4 Alzheimer's disease (AD) based on the 2018 National Institute on Aging (NIA)-Alzheimer's Association (AA) Research Framework Criteria.

-Mini-Mental State Examination (MMSE) score of 20 to 28, inclusive, at Screening.

-Blood-based biomarker results with a value consistent with amyloid positron emission tomography (PET) positivity. The biomarker will be chosen by the sponsor and described in the Laboratory Manual. Biomarker results will not be required for eligibility if the participant has a positive Amyloid PET scan meeting the central reader criteria.

•Amyloid PET scan results consistent with amyloid pathology.

•Stage B: Participants must have a study partner who spends a minimum average of 10 hours per week with the participant

Exclusion criteria

•Significant pathological findings on brain MRI at screening including, but not limited to, evidence of vasogenic edema, 4 or more microhemorrhages, any macrohemorrhages, any superficial siderosis, or severe white matter disease.

•Any anticoagulants or have a bleeding disorder that is not adequately controlled.

Endpoints (10)

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

Safety / tolerability / PK

Other (unclassified)

Amyloid biomarkers

Fluid / digital biomarkers

Amyloid biomarkers

1 endpoint

Primary/protocol endpoint

Stage B: Change in Brain Amyloid Plaque Deposition (Amyloid Centiloid Value)

Time frame:Baseline (Week 0) through Week 24

Amyloid PET Centiloid

change from baseline, improvement

Fluid / digital biomarkers

1 endpoint

Primary/protocol endpoint

Stage A: Cerebrospinal Fluid (CSF) Concentration as a Measure of ABBV-916 Crossing the Blood Brain Barrier

Time frame:Up to approximately 24 weeks

concentration, descriptive

Safety / tolerability / PK

6 endpoints

Primary/protocol endpoint

Number of Participants Experiencing Adverse Events (AEs)

Time frame:Up to approximately 160 weeks

event count, event

Primary/protocol endpoint

Stage A: Maximum Observed Serum Concentration (Cmax) for Multiple Ascending Dose of ABBV-916

Time frame:Up to approximately 24 weeks

concentration, descriptive

Primary/protocol endpoint

Stage A: Time to Cmax (Tmax) for Multiple Ascending Dose of ABBV-916

Time frame:Up to approximately 24 weeks

time to event, event

Primary/protocol endpoint

Stage A: Terminal Phase Elimination Half-Life (t1/2) of ABBV-916

Time frame:Up to approximately 24 weeks

concentration, descriptive

Primary/protocol endpoint

Stage A: Area Under the Concentration-Time Curve (AUC) of ABBV-916

Time frame:Up to approximately 24 weeks

concentration, descriptive

Primary/protocol endpoint

Stage A: Percentage of Participants With Antidrug Antibodies (ADA) as a Measure of Immunogenicity Following Multiple Ascending Dose of ABBV-916

Time frame:Up to approximately 24 weeks

threshold achievement, event

Other (unclassified)

2 endpoints

Primary/protocol endpoint/low confidence

Stage A: Apparent Terminal Phase Elimination Rate Constant (β) of ABBV-916

Time frame:Up to approximately 24 weeks

categorical status, descriptive

Primary/protocol endpoint/low confidence

Stage A: Trough Serum Concentration (Ctrough) of ABBV-916 at the End of a Dosing Interval

Time frame:Up to approximately 24 weeks

concentration, 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.