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New Alzheimer's drug ABBV-1758 enters early human trials

NCT ID NCT07599670

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 210 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

Oct 2030

An estimate. End dates often move.

Lead sponsor

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

50 to 90 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    13 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Adams Clinical /ID# 277754

    RECRUITING

    Watertown, Massachusetts, 02472, United States

  • Alpine Clinical Research Center - Boulder - 47th Street /ID# 277856

    RECRUITING

    Boulder, Colorado, 80301, United States

  • Alzheimer'S Research And Treatment Center - Stuart /ID# 278206

    RECRUITING

    Stuart, Florida, 34997, United States

  • Alzheimer's Research And Treatment Center - Wellington /ID# 277749

    RECRUITING

    Wellington, Florida, 33414, United States

  • Conquest Research - Winter Park /ID# 277760

    RECRUITING

    Winter Park, Florida, 32789, United States

  • Irvine Center for Clinical Research /ID# 277752

    RECRUITING

    Irvine, California, 92614, United States

  • K2 Medical Research - Clermont /ID# 277859

    RECRUITING

    Clermont, Florida, 34711, United States

  • K2 Medical Research - The Villages /ID# 278290

    RECRUITING

    Lady Lake, Florida, 32159, United States

  • Kerwin Medical Center /ID# 277788

    RECRUITING

    Dallas, Texas, 75231, United States

  • Key Clinical Research LLC /ID# 277800

    RECRUITING

    Bradenton, Florida, 34207, United States

  • Neurology Clinic - Cordova /ID# 277790

    RECRUITING

    Cordova, Tennessee, 38018, United States

  • The Second Affiliated Hospital of Guangzhou Medical University /ID# 284295

    RECRUITING

    Guangzhou, Guangdong, 510260, China

  • Xuanwu Hospital Capital Medical University /ID# 283310

    RECRUITING

    Beijing, Beijing Municipality, 100053, China

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Other studies related to the condition(s) this trial covers.