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
1 other identifier
interventional
210
1 country
11
Brief Summary
Alzheimer's disease (AD) is a progressive, irreversible neurological disorder and is the most common cause of dementia in the elderly population. Clinical symptoms of the disease may begin with occasional forgetfulness such as misplacement of items, forgetting important dates or events, and may progress to noticeable memory loss, increased confusion and agitation, and eventually, loss of independence and non-responsiveness. The purpose of this study is to test how safe ABBV-1758 is, how well it works, how the body processes it and what effects it has on the body. ABBV-1758 is an investigational drug being developed for the treatment of Alzheimer's disease. This study is conducted in 3 stages. Stage A is a multiple ascending dose study with a 1 in 5 chance (4:1 randomization) that participants are assigned to receive placebo. Stage B is a dose expansion phase, also using 4:1 randomization for ABBV-1758 or placebo. Stage C enrolls Japanese and Chinese participants with the same randomization scheme. Approximately 210 participants will be enrolled at about 55 sites in the United States, China, and Japan. Participants will receive intravenous (IV) or subcutaneous (SC) doses of ABBV-1758 or placebo once every 4 weeks (Q4W) for 24 weeks and will be followed for additional 12 weeks in the Follow-up Period. Participants will have the option of participating in a 12-month, blinded Extension Period receiving ABBV-1758 or placebo based on amyloid PET results. There may be higher treatment burden for participants in this trial compared to their standard of care due to study procedures. Participants will attend regular visits during the study at a hospital or clinic. The safety of the treatment will be checked by medical assessments, blood tests, and completing questionnaires.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started May 2026
Longer than P75 for phase_1
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 15, 2026
CompletedStudy Start
First participant enrolled
May 15, 2026
CompletedFirst Posted
Study publicly available on registry
May 20, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2030
June 23, 2026
June 1, 2026
3.9 years
May 15, 2026
June 18, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (20)
Percentage of Participants Experiencing Adverse Events (AEs)
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.
Up to approximately 40 weeks
Percentage of Participants with Abnormal Change from Baseline in Clinical Laboratory Test Results
Number of participants with abnormal change in clinical laboratory test results like hematology will be assessed.
Up to approximately 40 weeks
Percentage of Participants With Amyloid-Related Imaging Abnormalities (ARIA)
Amyloid related imaging abnormalities represent a spectrum of magnetic resonance imaging findings primarily observed in participants undergoing treatment with anti-amyloid therapies.
Up to approximately 40 weeks
Percentage of Participants with Abnormal Change From Baseline in Vital Sign Measurements
Number of participants with abnormal change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed.
Up to approximately 40 weeks
Percentage of Participants with Abnormal Change From Baseline in Electrocardiograms (ECGs) Parameters
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).
Up to approximately 40 weeks
Percentage of Participants Experiencing Any Suicidal Ideation or Suicidal Behavior As Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)
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.
Up to approximately 40 weeks
Stage A, B, and C: Change from Baseline in Brain Amyloid Load
Measured by amyloid positron emission tomography (PET)
Up to approximately 28 Weeks
Stage A and C: Maximum Plasma Concentration (Cmax) of ABBV-1758
Cmax of ABBV-1758
Up to approximately 40 weeks
Stage A and C: Time to Cmax (Tmax) of ABBV-1758
Tmax of ABBV-1758
Up to approximately 40 weeks
Stage A and C: Trough Concentration measured at the end of a dosing interval at steady state (Ctrough) of ABBV-1758
Ctrough of ABBV-1758
Up to approximately 40 weeks
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
AUCtau of ABBV-1758
Up to approximately 40 weeks
Stage A and C: Average Serum Concentration at Steady-State (Cav,ss) of ABBV-1758
Cav,ss of ABBV-1758
Up to approximately 40 weeks
Stage A and C: Accumulation ratio for (AUCtau) of ABBV-1758
AUCtau of ABBV-1758
Up to approximately 40 weeks
Stage A and C: Total Body Clearance (CL) of ABBV-1758
CL of ABBV-1758
Up to approximately 40 weeks
Stage A and C: Apparent Clearance (CL/F) of ABBV-1758
CL/F of ABBV-1758
Up to approximately 40 weeks
Stage A and C: Volume of Distribution at Steady-State (Vss)
Vss of ABBV-1758
Up to approximately 40 weeks
Stage A and C: Apparent Volume of Distribution during the Terminal Phase (Vz)
Vz of ABBV-1758
Up to approximately 40 weeks
Stage A and C: Terminal Phase Elimination Rate Constant (β) of ABBV-1758
β of ABBV-1758
Up to approximately 40 weeks
Stage A and C: Terminal Phase Elimination Half-Life (t1/2) of ABBV-1758
Terminal phase elimination half-life of ABBV-1758
Up to approximately 40 weeks
Stage A and C: Effective Half-Life (T1/2,eff)
T1/2,eff of ABBV-1758
Up to approximately 40 weeks
Study Arms (18)
Stage A-ABBV-1758 Dose A
EXPERIMENTALParticipants will receive ABBV-1758 dose A once every 4 weeks (Q4W).
Placebo for ABBV-1758 Dose A
PLACEBO COMPARATORParticipants will receive Placebo for ABBV-1758.
Stage A-ABBV-1758 Dose B
EXPERIMENTALParticipants will receive ABBV-1758 dose B Q4W.
Placebo for ABBV-1758 Dose B
PLACEBO COMPARATORParticipants will receive Placebo for ABBV-1758.
Stage A-ABBV-1758 Dose C
EXPERIMENTALParticipants will receive ABBV-1758 dose C Q4W.
Placebo for ABBV-1758 Dose C
PLACEBO COMPARATORParticipants will receive Placebo for ABBV-1758.
Stage A-ABBV-1758 Dose D
EXPERIMENTALParticipants will receive ABBV-1758 dose D Q4W.
Placebo for ABBV-1758 Dose D
PLACEBO COMPARATORParticipants will receive Placebo for ABBV-1758.
Stage B- ABBV-1758 - Expanded Cohort 1
EXPERIMENTALParticipants will receive ABBV-1758 dose determined in Stage A Q4W.
Placebo for ABBV-1758 - Expanded Cohort 1
PLACEBO COMPARATORParticipants will receive Placebo for ABBV-1758.
Stage B- ABBV-1758- Expanded Cohort 2
EXPERIMENTALParticipants will receive ABBV-1758 dose determined in Stage A Q4W.
Placebo for ABBV-1758- Expanded Cohort 2
PLACEBO COMPARATORParticipants will receive Placebo for ABBV-1758.
Stage C- ABBV-1758 - Japanese Cohort 1
EXPERIMENTALParticipants will receive ABBV-1758 dose determined in Stage A Q4W.
Placebo for ABBV-1758 - Japanese Cohort 1
PLACEBO COMPARATORParticipants will receive Placebo for ABBV-1758.
Stage C- ABBV-1758- Japanese Cohort 2
EXPERIMENTALParticipants will receive ABBV-1758 dose determined in Stage A Q4W.
Placebo for ABBV-1758- Japanese Cohort 2
PLACEBO COMPARATORParticipants will receive Placebo for ABBV-1758.
Stage C- ABBV-1758-Chinese Cohort
EXPERIMENTALParticipants will receive ABBV-1758 dose determined in Stage A Q4W.
Placebo for ABBV-1758- Chinese Cohort
PLACEBO COMPARATORParticipants will receive Placebo for ABBV-1758.
Interventions
Intravenous (IV) or Subcutaneous (SC)
Intravenous (IV) or Subcutaneous (SC)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (11)
Irvine Center for Clinical Research /ID# 277752
Irvine, California, 92614, United States
Alpine Clinical Research Center - Boulder - 47th Street /ID# 277856
Boulder, Colorado, 80301, United States
Key Clinical Research LLC /ID# 277800
Bradenton, Florida, 34207, United States
K2 Medical Research - Clermont /ID# 277859
Clermont, Florida, 34711, United States
K2 Medical Research - The Villages /ID# 278290
Lady Lake, Florida, 32159, United States
Alzheimer'S Research And Treatment Center - Stuart /ID# 278206
Stuart, Florida, 34997, United States
Alzheimer's Research And Treatment Center - Wellington /ID# 277749
Wellington, Florida, 33414, United States
Conquest Research - Winter Park /ID# 277760
Winter Park, Florida, 32789, United States
Adams Clinical /ID# 277754
Watertown, Massachusetts, 02472, United States
Neurology Clinic - Cordova /ID# 277790
Cordova, Tennessee, 38018, United States
Kerwin Medical Center /ID# 277788
Dallas, Texas, 75231, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 15, 2026
First Posted
May 20, 2026
Study Start
May 15, 2026
Primary Completion (Estimated)
April 1, 2030
Study Completion (Estimated)
October 1, 2030
Last Updated
June 23, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
- Access Criteria
- To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.