Alzheimer's Disease study: ABBV-1758
Official title A Study to Assess the Safety and Effects of ABBV-1758 Following Subcutaneous or Intravenous Injections in Participants With Alzheimer's Disease
ClinicalTrials.gov ID: NCT07599670
What this study is testing
What is ABBV-1758?
An investigational drug being studied as a potential treatment for Alzheimer’s disease.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether ABBV‑1758 is safe and how it works in people with Alzheimer’s disease.
- Who it's for
- You may be able to join if you have Alzheimer’s disease and live in the U.S., China, or Japan.
- What's involved
- You will receive either the drug or a pretend treatment once every four weeks. You will visit a clinic for check‑ups, blood tests, and questionnaires.
- Time commitment
- The study lasts about 36 weeks, with visits every four weeks and an extra 12‑week follow‑up.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 90
You may be able to join if
- In regions where timely testing is feasible (e.g., results available within 4 weeks of Visit 1), plasma biomarker that is predictive of elevated...
- Participants with amyloid positron emission tomography PET scan results consistent with significant amyloid pathology (as determined by a Centiloid...
- Participants must have a Mini-Mental State Examination (MMSE) score of 20 or higher at Screening.
You likely can't join 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...
- Participants who had prior exposure to ABBV-1758 or any history of exposure to anti-amyloid beta monoclonal antibody (mAb) treatment.
- 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)
See the full eligibility criteria
- 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...
- 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.
- 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...
- Participants who had prior exposure to ABBV-1758 or any history of exposure to anti-amyloid beta monoclonal antibody (mAb) treatment.
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Irvine, California, United States
- Boulder, Colorado, United States
- Bradenton, Florida, United States
- Clermont, Florida, United States
- Lady Lake, Florida, United States
- Stuart, Florida, United States
- Wellington, Florida, United States
- Winter Park, Florida, United States
- Watertown, Massachusetts, United States
- Cordova, Tennessee, United States
- Dallas, Texas, United States
- Beijing, Beijing Municipality, China
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Irvine, California, United States; Boulder, Colorado, United States; Bradenton, Florida, United States; Clermont, Florida, United States; Lady Lake, Florida, United States; Stuart, Florida, United States and 7 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.