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

NCT ID: NCT07599670
Registry status: Recruiting
Study type: Interventional
Phase: Phase 1 / Phase 2
Sponsor: AbbVie
Conditions: Alzheimer's Disease

Overview

ClinicalTrials.gov lists this study as Recruiting.

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

Enrollment: 210 participants (Estimated).

What is being studied

Drug: ABBV-1758
Drug: Placebo for ABBV-1758

Who may be eligible

Ages: 50 Years to 90 Years
Sex: All
Healthy volunteers accepted: No

ClinicalTrials.gov lists the following eligibility criteria.

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

Study locations

13 study locations are listed.

Recruiting site status is explicitly provided for 13 locations; 13 are listed as Recruiting.

Countries: China, United States

Beijing Municipality, China: 1
Guangdong, China: 1
California, United States: 1
Colorado, United States: 1
Florida, United States: 6
Massachusetts, United States: 1
Tennessee, United States: 1
Texas, United States: 1

Sample of listed locations

Xuanwu Hospital Capital Medical University /ID# 283310 — Beijing, Beijing Municipality, 100053, China — Recruiting
The Second Affiliated Hospital of Guangzhou Medical University /ID# 284295 — Guangzhou, Guangdong, 510260, China — Recruiting
Irvine Center for Clinical Research /ID# 277752 — Irvine, California, 92614, United States — Recruiting
Alpine Clinical Research Center - Boulder - 47th Street /ID# 277856 — Boulder, Colorado, 80301, United States — Recruiting
Key Clinical Research LLC /ID# 277800 — Bradenton, Florida, 34207, United States — Recruiting
K2 Medical Research - Clermont /ID# 277859 — Clermont, Florida, 34711, United States — Recruiting
K2 Medical Research - The Villages /ID# 278290 — Lady Lake, Florida, 32159, United States — Recruiting
Alzheimer'S Research And Treatment Center - Stuart /ID# 278206 — Stuart, Florida, 34997, United States — Recruiting
Alzheimer's Research And Treatment Center - Wellington /ID# 277749 — Wellington, Florida, 33414, United States — Recruiting
Conquest Research - Winter Park /ID# 277760 — Winter Park, Florida, 32789, United States — Recruiting
Adams Clinical /ID# 277754 — Watertown, Massachusetts, 02472, United States — Recruiting
Neurology Clinic - Cordova /ID# 277790 — Cordova, Tennessee, 38018, United States — Recruiting
Kerwin Medical Center /ID# 277788 — Dallas, Texas, 75231, United States — Recruiting

Study details

Start date: May 15, 2026
Primary completion date: October 1, 2030
Completion date: October 1, 2030
First posted: May 20, 2026

Source and update information

Source: ClinicalTrials.gov
NCT ID: NCT07599670
Registry last updated: September 18, 2026
QualifiedStudies registry data refreshed: September 28, 2026
QualifiedStudies record fetched: September 28, 2026

View NCT07599670 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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