NCT07599670 · AbbVie
A Study to Assess the Safety and Effects of ABBV-1758 Following Subcutaneous or Intravenous Injections in Participants With Alzheimer's Disease
What this study is about
Alzheimer's disease (AD) is a progressive, irreversible neurological disorder and is the most common cause of dementia in the elderly population.
View original scientific description
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.
Interventions
DRUG
ABBV-1758
Intravenous (IV) or Subcutaneous (SC)
DRUG
Placebo for ABBV-1758
Intravenous (IV) or Subcutaneous (SC)
DRUG
ABBV-1758
Subcutaneous (SC)
DRUG
Placebo for ABBV-1758
Subcutaneous (SC)
Primary outcome measures
Percentage of Participants Experiencing Adverse Events (AEs)
Time frame: 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 Results
Time frame: Up 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)
Time frame: 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 Measurements
Time frame: Up 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) Parameters
Time frame: Up 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)
Time frame: 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 Load
Time frame: Up to approximately 28 Weeks
Measured by amyloid positron emission tomography (PET)
Stage A and C: Maximum Plasma Concentration (Cmax) of ABBV-1758
Time frame: Up to approximately 40 weeks
Cmax of ABBV-1758
Stage A and C: Time to Cmax (Tmax) of ABBV-1758
Time frame: Up 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-1758
Time frame: Up 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-1758
Time frame: Up to approximately 40 weeks
AUCtau of ABBV-1758
Stage A and C: Average Serum Concentration at Steady-State (Cav,ss) of ABBV-1758
Time frame: Up to approximately 40 weeks
Cav,ss of ABBV-1758
Stage A and C: Accumulation ratio for (AUCtau) of ABBV-1758
Time frame: Up to approximately 40 weeks
AUCtau of ABBV-1758
Stage A and C: Total Body Clearance (CL) of ABBV-1758
Time frame: Up to approximately 40 weeks
CL of ABBV-1758
Stage A and C: Apparent Clearance (CL/F) of ABBV-1758
Time frame: Up to approximately 40 weeks
CL/F of ABBV-1758
Stage A and C: Volume of Distribution at Steady-State (Vss)
Time frame: Up to approximately 40 weeks
Vss of ABBV-1758
Stage A and C: Apparent Volume of Distribution during the Terminal Phase (Vz)
Time frame: Up to approximately 40 weeks
Vz of ABBV-1758
Stage A and C: Terminal Phase Elimination Rate Constant (β) of ABBV-1758
Time frame: Up to approximately 40 weeks
β of ABBV-1758
Stage A and C: Terminal Phase Elimination Half-Life (t1/2) of ABBV-1758
Time frame: Up to approximately 40 weeks
Terminal phase elimination half-life of ABBV-1758
Stage A and C: Effective Half-Life (T1/2,eff)
Time frame: Up to approximately 40 weeks
T1/2,eff of ABBV-1758
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Irvine, California
- Boulder, Colorado
- Bradenton, Florida
- Clermont, Florida
- Lady Lake, Florida
- Stuart, Florida
- Wellington, Florida
- Winter Park, Florida
- Watertown, Massachusetts
- Cordova, Tennessee
- Dallas, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 25, 2026 · Source of record for eligibility and locations