ABBV-1758 in Alzheimer's Disease: safety and effects after injections

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial explores the safety, pharmacology, and potential effectiveness of ABBV-1758 in participants with Alzheimer’s disease. It uses a three-stage design: Stage A tests multiple ascending doses with mostly placebo; Stage B expands on dosing with continued randomization to ABBV-1758 or placebo; Stage C enrolls Japanese and Chinese participants under the same randomization. The study assesses safety, how the drug is processed in the body, and its effects on disease-related outcomes. Enrollment targets adults with confirmed amyloid pathology and a baseline MMSE score of 20 or higher, with careful screening to exclude other causes of dementia.

Why it matters

Who can join: the full rules

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 it's running

• Irvine Center for Clinical Research /ID# 277752
  Irvine, California, United States Recruiting
• Alpine Clinical Research Center - Boulder - 47th Street /ID# 277856
  Boulder, Colorado, United States Recruiting
• Key Clinical Research LLC /ID# 277800
  Bradenton, Florida, United States Recruiting
• K2 Medical Research - Clermont /ID# 277859
  Clermont, Florida, United States Recruiting
• K2 Medical Research - The Villages /ID# 278290
  Lady Lake, Florida, United States Recruiting
• Alzheimer'S Research And Treatment Center - Stuart /ID# 278206
  Stuart, Florida, United States Recruiting

Study contacts

• Study coordinator: Abbvie Call Center
• Email: abbvieclinicaltrials@abbvie.com
• Phone: 844-663-3742

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.