New Alzheimer's drug ABBV-1758 enters early human trials
NCT ID NCT07599670
First seen Jun 24, 2026 · Last updated Sep 18, 2026 · Updated 6 times
Summary
This study tests an experimental drug called ABBV-1758 in about 210 people with Alzheimer's disease. The drug is given by IV or injection every 4 weeks for 24 weeks. Researchers are checking if it is safe and whether it can reduce amyloid plaques in the brain, a hallmark of Alzheimer's.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ABBV-1758
- What this could lead to
- If it works, this could point toward a treatment that slows Alzheimer's by reducing amyloid buildup in the brain.
- What could go wrong
- This is an early Phase 1/2 trial with only 210 participants, so results may not confirm effectiveness. There are also known risks like brain swelling or bleeding (ARIA).
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 210 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2026
- Expected to finish
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Oct 2030
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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50 to 90 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
13 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Adams Clinical /ID# 277754
RECRUITINGWatertown, Massachusetts, 02472, United States
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Alpine Clinical Research Center - Boulder - 47th Street /ID# 277856
RECRUITINGBoulder, Colorado, 80301, United States
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Alzheimer'S Research And Treatment Center - Stuart /ID# 278206
RECRUITINGStuart, Florida, 34997, United States
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Alzheimer's Research And Treatment Center - Wellington /ID# 277749
RECRUITINGWellington, Florida, 33414, United States
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Conquest Research - Winter Park /ID# 277760
RECRUITINGWinter Park, Florida, 32789, United States
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Irvine Center for Clinical Research /ID# 277752
RECRUITINGIrvine, California, 92614, United States
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K2 Medical Research - Clermont /ID# 277859
RECRUITINGClermont, Florida, 34711, United States
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K2 Medical Research - The Villages /ID# 278290
RECRUITINGLady Lake, Florida, 32159, United States
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Kerwin Medical Center /ID# 277788
RECRUITINGDallas, Texas, 75231, United States
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Key Clinical Research LLC /ID# 277800
RECRUITINGBradenton, Florida, 34207, United States
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Neurology Clinic - Cordova /ID# 277790
RECRUITINGCordova, Tennessee, 38018, United States
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The Second Affiliated Hospital of Guangzhou Medical University /ID# 284295
RECRUITINGGuangzhou, Guangdong, 510260, China
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Xuanwu Hospital Capital Medical University /ID# 283310
RECRUITINGBeijing, Beijing Municipality, 100053, China
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