Tests ABBV-1758 for safety and effects in Alzheimer's disease
Tests the investigational drug ABBV-1758 against placebo in adults with Alzheimer's disease.
Key facts
- Who runs it
- AbbVie
- Where
- Beijing and Guangzhou, ChinaSee the 2 sitesAlso in 1 other country, 11 sites
- Trial code
- Registry title
- A Study to Assess the Safety and Effects of ABBV-1758 Following Subcutaneous or Intravenous Injections in Participants With Alzheimer's Disease
- Status
- Recruiting
- Phase
- Phase 1/2
- People taking part
- 210 people, planned
- Started
- 15 May 2026
- Expected to end
- Oct 2030
- Type of study
- Interventional, 18 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- ABBV-1758
- Placebo for ABBV-1758
- Record updated
- 18 September 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 50 to 90 with Alzheimer's disease and signs of amyloid in the brain. It tests how safe ABBV-1758 is and how well it works.
- Age
- 50 to 90 years
- Sex
- All sexes can join.
- Disease stage
- Alzheimer's disease with a Mini-Mental State Examination (MMSE) score of 20 or higher at screening.
- Earlier treatment
- People who had ABBV-1758 before, or any anti-amyloid beta monoclonal antibody (mAb) treatment, cannot join.
- Biomarker or test result
- Brain amyloid shown by a PET scan (Centiloid value of 50 or higher), or by a blood biomarker test at screening where results come back within 4 weeks.
Main reasons for not taking part
- Brain MRI showing another possible cause of dementia
- Serious illness that is not well controlled
- Earlier ABBV-1758 or anti-amyloid beta mAb treatment
- Brain MRI findings such as vasogenic edema, 4 or more microhemorrhages, any macrohemorrhage, any superficial siderosis or severe white matter disease
The registry criteria, word for word
Show all 6 criteriaShow less
Who can take part
- 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
Who cannot take part
- Participants who had prior exposure to ABBV-1758 or any history of exposure to anti-amyloid beta monoclonal antibody (mAb) treatment
- Participants with screening magnetic resonance imaging (MRI) that show evidence of another potential etiology for progressive dementia
- 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
- 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)
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 50 and 90 years old?
Where in China
Also in 1 other country, 11 sites
- Xuanwu Hospital Capital Medical University /ID# 283310Beijing, ChinaTaking people
- The Second Affiliated Hospital of Guangzhou Medical University /ID# 284295Guangzhou, ChinaTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 18 groups in the trial
- Stage A-ABBV-1758 Dose ATreatment being tested
Participants will receive ABBV-1758 dose A once every 4 weeks (Q4W).
Treatment: ABBV-1758
- Placebo for ABBV-1758 Dose APlacebo, for comparison
Participants will receive Placebo for ABBV-1758.
Treatment: Placebo for ABBV-1758
- Stage A-ABBV-1758 Dose BTreatment being tested
Participants will receive ABBV-1758 dose B Q4W.
Treatment: ABBV-1758
- Placebo for ABBV-1758 Dose BPlacebo, for comparison
Participants will receive Placebo for ABBV-1758.
Treatment: Placebo for ABBV-1758
- Stage A-ABBV-1758 Dose CTreatment being tested
Participants will receive ABBV-1758 dose C Q4W.
Treatment: ABBV-1758
- Placebo for ABBV-1758 Dose CPlacebo, for comparison
Participants will receive Placebo for ABBV-1758.
Treatment: Placebo for ABBV-1758
- Stage A-ABBV-1758 Dose DTreatment being tested
Participants will receive ABBV-1758 dose D Q4W.
Treatment: ABBV-1758
- Placebo for ABBV-1758 Dose DPlacebo, for comparison
Participants will receive Placebo for ABBV-1758.
Treatment: Placebo for ABBV-1758
- Stage B- ABBV-1758 - Expanded Cohort 1Treatment being tested
Participants will receive ABBV-1758 dose determined in Stage A Q4W.
Treatment: ABBV-1758
- Placebo for ABBV-1758 - Expanded Cohort 1Placebo, for comparison
Participants will receive Placebo for ABBV-1758.
Treatment: Placebo for ABBV-1758
- Stage B- ABBV-1758- Expanded Cohort 2Treatment being tested
Participants will receive ABBV-1758 dose determined in Stage A Q4W.
Treatment: ABBV-1758
- Placebo for ABBV-1758- Expanded Cohort 2Placebo, for comparison
Participants will receive Placebo for ABBV-1758.
Treatment: Placebo for ABBV-1758
- Stage C- ABBV-1758 - Japanese Cohort 1Treatment being tested
Participants will receive ABBV-1758 dose determined in Stage A Q4W.
Treatment: ABBV-1758
- Placebo for ABBV-1758 - Japanese Cohort 1Placebo, for comparison
Participants will receive Placebo for ABBV-1758.
Treatment: Placebo for ABBV-1758
- Stage C- ABBV-1758- Japanese Cohort 2Treatment being tested
Participants will receive ABBV-1758 dose determined in Stage A Q4W.
Treatment: ABBV-1758
- Placebo for ABBV-1758- Japanese Cohort 2Placebo, for comparison
Participants will receive Placebo for ABBV-1758.
Treatment: Placebo for ABBV-1758
- Stage C- ABBV-1758-Chinese CohortTreatment being tested
Participants will receive ABBV-1758 dose determined in Stage A Q4W.
Treatment: ABBV-1758
- Placebo for ABBV-1758- Chinese CohortPlacebo, for comparison
Participants will receive Placebo for ABBV-1758.
Treatment: Placebo for ABBV-1758
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Plain-language title
- Tests ABBV-1758 for safety and effects in Alzheimer's diseaseGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 13 November 2026.
- Fit questions
- Built from NCT07599670, who can take part
- Record updated
- 18 September 2026