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NCT Number: NCT07599670

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

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.

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Irvine Center for Clinical Research /ID# 277752, Irvine, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ABBV-1758

Drug

Intravenous (IV) or Subcutaneous (SC)

Placebo for ABBV-1758

Drug

Intravenous (IV) or Subcutaneous (SC)

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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).

  6. 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.

  7. 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)

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

    Time frame: Up to approximately 40 weeks

    Cmax of ABBV-1758

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

    Time frame: Up to approximately 40 weeks

    Tmax of ABBV-1758

  10. 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

  11. 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

  12. 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

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

    Time frame: Up to approximately 40 weeks

    AUCtau of ABBV-1758

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

    Time frame: Up to approximately 40 weeks

    CL of ABBV-1758

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

    Time frame: Up to approximately 40 weeks

    CL/F of ABBV-1758

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

    Time frame: Up to approximately 40 weeks

    Vss of ABBV-1758

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

    Time frame: Up to approximately 40 weeks

    Vz of ABBV-1758

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

    Time frame: Up to approximately 40 weeks

    β of ABBV-1758

  19. 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

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

    Time frame: Up to approximately 40 weeks

    T1/2,eff of ABBV-1758

Study contacts

Contact information is provided by the study sponsor or research team.

ABBVIE CALL CENTER

CONTACT

[email protected]

844-663-3742

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
May 20, 2026
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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