A Phase 1/2 interventional study of ABBV-1758 and Placebo for ABBV-1758 in Alzheimer's Disease, sponsored by AbbVie. Recruiting at 13 sites in 2 countries. Open to participants aged 50 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by AbbVie · Phase 1/2, Interventional, and Treatment
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.
3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.
This study's planned enrollment of 210 is above the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →AbbVie is the lead sponsor of 953 studies on the registry; 136 are open to participants now.
Of its 350 completed or terminated interventional studies of FDA-regulated products, 210 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants meeting all the following criteria for Alzheimer's disease (AD):
Exclusion Criteria:
Participants with other significant pathological findings on brain MRI at screening, including but not limited to:
Participants will receive ABBV-1758 dose A once every 4 weeks (Q4W).
Drug: ABBV-1758
Participants will receive Placebo for ABBV-1758.
Drug: Placebo for ABBV-1758
Participants will receive ABBV-1758 dose B Q4W.
Drug: ABBV-1758
Participants will receive Placebo for ABBV-1758.
Drug: Placebo for ABBV-1758
Participants will receive ABBV-1758 dose C Q4W.
Drug: ABBV-1758
Participants will receive Placebo for ABBV-1758.
Drug: Placebo for ABBV-1758
Participants will receive ABBV-1758 dose D Q4W.
Drug: ABBV-1758
Participants will receive Placebo for ABBV-1758.
Drug: Placebo for ABBV-1758
Participants will receive ABBV-1758 dose determined in Stage A Q4W.
Drug: ABBV-1758
Participants will receive Placebo for ABBV-1758.
Drug: Placebo for ABBV-1758
Participants will receive ABBV-1758 dose determined in Stage A Q4W.
Drug: ABBV-1758
Participants will receive Placebo for ABBV-1758.
Drug: Placebo for ABBV-1758
Participants will receive ABBV-1758 dose determined in Stage A Q4W.
Drug: ABBV-1758
Participants will receive Placebo for ABBV-1758.
Drug: Placebo for ABBV-1758
Participants will receive ABBV-1758 dose determined in Stage A Q4W.
Drug: ABBV-1758
Participants will receive Placebo for ABBV-1758.
Drug: Placebo for ABBV-1758
Participants will receive ABBV-1758 dose determined in Stage A Q4W.
Drug: ABBV-1758
Participants will receive Placebo for ABBV-1758.
Drug: Placebo for ABBV-1758
Intravenous (IV) or Subcutaneous (SC)
Intravenous (IV) or Subcutaneous (SC)
Subcutaneous (SC)
Subcutaneous (SC)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: Up to approximately 40 weeks
Stage A, B, and C: Change from Baseline in Brain Amyloid Load
Measured by amyloid positron emission tomography (PET)
Time frame: Up to approximately 28 Weeks
Stage A and C: Maximum Plasma Concentration (Cmax) of ABBV-1758
Cmax of ABBV-1758
Time frame: Up to approximately 40 weeks
Stage A and C: Time to Cmax (Tmax) of ABBV-1758
Tmax of ABBV-1758
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Up to approximately 40 weeks
Stage A and C: Accumulation ratio for (AUCtau) of ABBV-1758
AUCtau of ABBV-1758
Time frame: Up to approximately 40 weeks
Stage A and C: Total Body Clearance (CL) of ABBV-1758
CL of ABBV-1758
Time frame: Up to approximately 40 weeks
Stage A and C: Apparent Clearance (CL/F) of ABBV-1758
CL/F of ABBV-1758
Time frame: Up to approximately 40 weeks
Stage A and C: Volume of Distribution at Steady-State (Vss)
Vss of ABBV-1758
Time frame: Up to approximately 40 weeks
Stage A and C: Apparent Volume of Distribution during the Terminal Phase (Vz)
Vz of ABBV-1758
Time frame: Up to approximately 40 weeks
Stage A and C: Terminal Phase Elimination Rate Constant (β) of ABBV-1758
β of ABBV-1758
Time frame: 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
Time frame: Up to approximately 40 weeks
Stage A and C: Effective Half-Life (T1/2,eff)
T1/2,eff of ABBV-1758
Time frame: Up to approximately 40 weeks
Plan to share: Yes — 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.
Supporting information: Study protocol, Sap
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