A Study to Assess the Adverse Events, Change in Disease Activity, and How Intravenous ABBV-1758 Moves Through the Body of Adult Participants With Alzheimer's Disease

NCT07599670 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: M25-804
• Study Type: interventional
• Target: 210
• Locations: 0 countries
• Sites: N/A

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. This study is to assess the adverse events, change in disease activity, and how intravenous ABBV-1758 moves through the body of adult participants with Alzheimer's Disease ABBV-1758 is an investigational drug being developed for the treatment of Alzheimer's disease in adults. 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. This may be followed by a 12-month, blinded Extension Period where participants receive ABBV-1758 or placebo based on their amyloid positron emission tomography (PET) results. Approximately 210 participants will be enrolled at about 65 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 an additional 12 weeks. 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.

Conditions

Alzheimer's Disease

Keywords

Alzheimer's Disease; ABBV-1758

Outcome Measures

Primary Outcomes (20)

• Number 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 36 weeks

• Number of Participants with Abnormal Change in Clinical Laboratory Test Results Like Hematology will be Assessed

  Number of participants with abnormal change in clinical laboratory test results like hematology will be assessed.

  Up to approximately 36 weeks

• Change From Baseline in amyloid-related imaging abnormalities (ARIA) Measured by Magnetic Resonance Im-aging (MRI)

  Magnetic resonance imaging (MRI) of several different brain regions was per-formed, and volumetric analysis was con-ducted to quantify midbrain atrophy. Negative changes in values indicate a re-duction in volume.

  Up to approximately 36 weeks

• Number 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 36 weeks

• Change From Baseline in Electrocardiograms (ECGs)

  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 36 weeks

• Change from Baseline in 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 36 weeks

• Stage A, B, and C: Change from Baseline in Brain Amyloid Plaque Deposition

  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 12 months

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

  Tmax of ABBV-1758

  Up to approximately 12 months

• 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 12 months

• 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 12 months

• Stage A and C: Average Serum Concentration at Steady-State (Cav,ss) of ABBV-1758

  Cav,ss of ABBV-1758

  Up to approximately 12 months

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

  AUCtau of ABBV-1758

  Up to approximately 12 months

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

  CL of ABBV-1758

  Up to approximately 12 months

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

  CL/F of ABBV-1758

  Up to approximately 12 months

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

  Vss of ABBV-1758

  Up to approximately 12 months

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

  Vz of ABBV-1758

  Up to approximately 12 months

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

  β of ABBV-1758

  Up to approximately 12 months

• 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 12 months

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

  T1/2,eff of ABBV-1758

  Up to approximately 12 months

Study Arms (18)

Stage A-ABBV-1758 Dose A

EXPERIMENTAL

Participants will receive ABBV-1758 dose A once every 4 weeks (Q4W).

Drug: ABBV-1758

Stage A-Placebo for ABBV-1758 Dose A

PLACEBO COMPARATOR

Participants will receive Placebo dose A once every 4 weeks (Q4W).

Drug: Placebo for ABBV-1758

Stage A-ABBV-1758 Dose B

EXPERIMENTAL

Participants will receive ABBV-1758 dose B Q4W.

Drug: ABBV-1758

Stage A-Placebo for ABBV-1758 Dose B

PLACEBO COMPARATOR

Participants will receive Placebo dose B Q4W.

Drug: Placebo for ABBV-1758

Stage A-ABBV-1758 Dose C

EXPERIMENTAL

Participants will receive ABBV-1758 dose C Q4W.

Drug: ABBV-1758

Stage A-Placebo for ABBV-1758 Dose C

PLACEBO COMPARATOR

Participants will receive Placebo dose C Q4W.

Drug: Placebo for ABBV-1758

Stage A-ABBV-1758 Dose D

EXPERIMENTAL

Participants will receive ABBV-1758 dose D Q4W.

Drug: ABBV-1758

Stage A-Placebo for ABBV-1758 Dose D

PLACEBO COMPARATOR

Participants will receive Placebo dose D Q4W.

Drug: Placebo for ABBV-1758

Stage B- ABBV-1758 - Expanded Cohort 1

EXPERIMENTAL

Participants will receive ABBV-1758 dose determined in Stage A Q4W.

Drug: ABBV-1758

Stage B- Placebo for ABBV-1758 - Expanded Cohort 1

PLACEBO COMPARATOR

Participants will receive Placebo dose determined in Stage A Q4W.

Drug: Placebo for ABBV-1758

Stage B- ABBV-1758- Expanded Cohort 2

EXPERIMENTAL

Participants will receive ABBV-1758 dose determined in Stage A Q4W.

Drug: ABBV-1758

Stage B- Placebo for ABBV-1758- Expanded Cohort 2

PLACEBO COMPARATOR

Participants will receive Placebo dose determined in Stage A Q4W.

Drug: Placebo for ABBV-1758

Stage C- ABBV-1758 - Japanese Cohort 1

EXPERIMENTAL

Participants will receive ABBV-1758 dose determined in Stage A Q4W.

Drug: ABBV-1758

Stage C- Placebo for ABBV-1758 - Japanese Cohort 1

PLACEBO COMPARATOR

Participants will receive Placebo dose determined in Stage A Q4W.

Drug: Placebo for ABBV-1758

Stage C- ABBV-1758- Japanese Cohort 2

EXPERIMENTAL

Participants will receive ABBV-1758 dose determined in Stage A Q4W.

Drug: ABBV-1758

Stage C- Placebo for ABBV-1758- Japanese Cohort 2

PLACEBO COMPARATOR

Participants will receive Placebo dose determined in Stage A Q4W.

Drug: Placebo for ABBV-1758

Stage C- ABBV-1758-Chinese Cohort

EXPERIMENTAL

Participants will receive ABBV-1758 dose determined in Stage A Q4W.

Drug: ABBV-1758

Stage C- Placebo for ABBV-1758- Chinese Cohort

PLACEBO COMPARATOR

Participants will receive Placebo dose determined in Stage A Q4W.

Drug: Placebo for ABBV-1758

Interventions

ABBV-1758 DRUG

Intravenous (IV) or Subcutaneous (SC)

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-1758- Japanese Cohort 2; Stage C- ABBV-1758-Chinese Cohort

Placebo for ABBV-1758 DRUG

Intravenous (IV) or Subcutaneous (SC)

Stage A-Placebo for ABBV-1758 Dose D; Stage B- Placebo for ABBV-1758 - Expanded Cohort 1; Stage B- Placebo for ABBV-1758- Expanded Cohort 2; Stage C- Placebo for ABBV-1758 - Japanese Cohort 1; Stage C- Placebo for ABBV-1758- Chinese Cohort; Stage C- Placebo for ABBV-1758- Japanese Cohort 2

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants meeting all the following criteria for Alzheimer's disease (AD):
• Plasma pTau217/Aβ42 ratio that is predictive of elevated brain amyloid at Screening.
• 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.

Sponsors & Collaborators

• AbbVie: lead

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Central Study Contacts

ABBVIE CALL CENTER

CONTACT

844-663-3742; abbvieclinicaltrials@abbvie.com

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): November 1, 2030
• Last Updated: May 20, 2026

Record last verified: 2026-05

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/