A Study to Assess the Safety and Effects of ABBV-1758 Following Subcutaneous or Intravenous Injections in Participants With Alzheimer's Disease
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Official title
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of ABBV-1758 in Participants With Alzheimer's Disease
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07599670
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 210 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 50 Years to 90 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 15, 2026 (Actual)
- Primary completion
- Oct 2030 (Estimated)
- Completion
- Oct 2030 (Estimated)
- Last update posted
- Sep 18, 2026
2026 – 2030
United States locations
- U.S. sites
- 11
- U.S. states
- 6
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Irvine Center for Clinical Research /ID# 277752 | Irvine | California | 92614 | Recruiting |
| Alpine Clinical Research Center - Boulder - 47th Street /ID# 277856 | Boulder | Colorado | 80301 | Recruiting |
| Key Clinical Research LLC /ID# 277800 | Bradenton | Florida | 34207 | Recruiting |
| K2 Medical Research - Clermont /ID# 277859 | Clermont | Florida | 34711 | Recruiting |
| K2 Medical Research - The Villages /ID# 278290 | Lady Lake | Florida | 32159 | Recruiting |
| Alzheimer'S Research And Treatment Center - Stuart /ID# 278206 | Stuart | Florida | 34997 | Recruiting |
| Alzheimer's Research And Treatment Center - Wellington /ID# 277749 | Wellington | Florida | 33414 | Recruiting |
| Conquest Research - Winter Park /ID# 277760 | Winter Park | Florida | 32789 | Recruiting |
| Adams Clinical /ID# 277754 | Watertown | Massachusetts | 02472 | Recruiting |
| Neurology Clinic - Cordova /ID# 277790 | Cordova | Tennessee | 38018 | Recruiting |
| Kerwin Medical Center /ID# 277788 | Dallas | Texas | 75231 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07599670, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 18, 2026 · Synced Nov 15, 2026
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