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ABBV-1758 / Placebo for ABBV-1758 / Alzheimer's Disease · Phase 1/2 Trial
ClinicalTrials.gov · August 14, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a registered Phase 1/2 dose-escalation and safety study of ABBV-1758, an investigational anti-amyloid agent for Alzheimer's disease, enrolling approximately 210 participants across the United States, China, and Japan. The trial is currently recruiting and has not yet reported results; primary endpoints focus on safety, tolerability, amyloid-related imaging abnormalities (ARIA), and pharmacokinetics, with optional 12-month blinded extension. No clinical efficacy data are available from this registry record.
Phase 1/2, Interventional, Randomized, Sequential, Triple masking, Treatment purpose. Alzheimer's Disease; age from 50 Years; to 90 Years. Intervention: Stage A-ABBV-1758 Dose A; Stage A-ABBV-1758 Dose B; Stage A-ABBV-1758 Dose C; Stage A-ABBV-1758 Dose D; Stage B- ABBV-1758 - Expanded Cohort 1; Stage B- ABBV-1758- Expanded Cohort 2; Stage C- ABBV-1758 - Japanese Cohort 1; Stage C- ABBV-17…. Compared with: Placebo for ABBV-1758 Dose A — Placebo Comparator; Placebo for ABBV-1758 Dose B — Placebo Comparator; Placebo for ABBV-1758 Dose C — Placebo Comparator; Placebo for ABBV-1758 Dose D — Placebo Comparator; Placebo for ABBV-1758 - Expanded Co…. n = 210. 11 sites: United States.
This is a registered Phase 1/2 dose-escalation and safety study of ABBV-1758, an investigational anti-amyloid agent for Alzheimer's disease, enrolling approximately 210 participants across the United States, China, and Japan. The trial is currently recruiting and has not yet reported results; primary endpoints focus on safety, tolerability, amyloid-related imaging abnormalities (ARIA), and pharmacokinetics, with optional 12-month blinded extension. No clinical efficacy data are available from this registry record.
Results from this trial, including safety and amyloid PET response, are not yet reported.
This trial is in early recruitment phase with no efficacy results yet available. Clinicians and researchers should monitor for future publication of safety and pharmacokinetic data, which will inform later-stage development of ABBV-1758. The focus on ARIA assessment reflects the known risks of anti-amyloid monoclonal antibodies.
This is a Phase 1/2 trial registration with no reported results; it describes a planned safety and dose-escalation study in a small population with surrogate endpoints (amyloid imaging) and safety assessments only.
As stated by the source record.
Quoted from the source exactly as published.
This trial is in early recruitment phase with no efficacy results yet available. Clinicians and researchers should monitor for future publication of safety and pharmacokinetic data, which will inform later-stage development of ABBV-1758. The focus on ARIA assessment reflects the known risks of anti-amyloid monoclonal antibodies.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07599670). This is a study registration, not published results. Lead sponsor: AbbVie. Recruitment status: RECRUITING. Phase: PHASE1, PHASE2. Study type: INTERVENTIONAL. Enrollment: 210 participants (ESTIMATED). Conditions: Alzheimer's Disease. Interventions: DRUG: ABBV-1758; DRUG: Placebo for ABBV-1758; DRUG: ABBV-1758; DRUG: Placebo for ABBV-1758. Primary outcome measures: Percentage of Participants Experiencing Adverse Events (AEs) , Up to approximately 40 weeks; Percentage of Participants with Abnormal Change from Baseline in Clinical Laboratory Test Results , Up to approximately 40 weeks; Percentage of Participants With Amyloid-Related Imaging Abnormalities (ARIA) , Up to approximately 40 weeks; Percentage of Participants with Abnormal Change From Baseline in Vital Sign Measurements , Up to approximately 40 weeks; Percentage of Participants with Abnormal Change From Baseline in Electrocardiograms (ECGs) Parameters , 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) , Up to approximately 40 weeks; Stage A, B, and C: Change from Baseline in Brain Amyloid Load , Up to approximately 28 Weeks; Stage A and C: Maximum Plasma Concentration (Cmax) of ABBV-1758 , Up to approximately 40 weeks; Stage A and C: Time to Cmax (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 , 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 , Up to approximately 40 weeks; Stage A and C: Average Serum Concentration at Steady-State (Cav,ss) of ABBV-1758 , Up to approximately 40 weeks; Stage A and C: Accumulation ratio for (AUCtau) of ABBV-1758 , Up to approximately 40 weeks; Stage A and C: Total Body Clearance (CL) of ABBV-1758 , Up to approximately 40 weeks; Stage A and C: Apparent Clearance (CL/F) of ABBV-1758 , Up to approximately 40 weeks; Stage A and C: Volume of Distribution at Steady-State (Vss) , Up to approximately 40 weeks; Stage A and C: Apparent Volume of Distribution during the Terminal Phase (Vz) , Up to approximately 40 weeks; Stage A and C: Terminal Phase Elimination Rate Constant (β) of ABBV-1758 , Up to approximately 40 weeks; Stage A and C: Terminal Phase Elimination Half-Life (t1/2) of ABBV-1758 , Up to approximately 40 weeks; Stage A and C: Effective Half-Life (T1/2,eff) , Up to approximately 40 weeks. 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.
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