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New drug ABBV-916 aims to slow Alzheimer's in early stages

NCT ID NCT05291234

Disease control Sponsor: AbbVie Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested an experimental drug called ABBV-916 in people with early Alzheimer's disease. Participants received either the drug or a placebo intravenously every 4 weeks for 6 months, with an optional 2-year extension where everyone gets the drug. The goal was to check safety and whether the drug 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-916 (an investigational drug given intravenously)
What this could lead to
If successful, ABBV-916 could slow the progression of early Alzheimer's disease by reducing amyloid plaques in the brain.
What could go wrong
This is a Phase 2 trial with only 106 participants, so results may not apply to everyone. The drug may cause side effects or fail to show meaningful benefit.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

106 people

The number who actually took part.

Started

Aug 2022

Finished

Nov 2025

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: * Diagnosis of Stage 3 or Stage 4 Alzheimer's disease (AD) based on the 2018 National Institute on Aging (NIA)-Alzheimer's Association (AA) Research Framework Criteria. * Mini-Mental State Examination (MMSE) score of 20 to 28, inclusive, at Screening. * Blood-based biomarker results with a value consistent with amyloid positron emission tomography (PET) positivity. The biomarker will be chosen by the sponsor and described in the Laboratory Manual. Biomarker results will not be required for eligibility if the participant has a positive Amyloid PET scan meeting the central reader criteria. * Amyloid PET scan results consistent with amyloid pathology. * Stage B: Participants must have a study partner who spends a minimum average of 10 hours per week with the participant. Exclusion Criteria: * Significant pathological findings on brain MRI at screening including, but not limited to, evidence of vasogenic edema, 4 or more microhemorrhages, any macrohemorrhages, any superficial siderosis, or severe white matter disease. * Any anticoagulants or have a bleeding disorder that is not adequately controlled.

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Conditions

The condition(s) this trial relates to.

Alzheimer disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Alzheimer's disease(AD)

Contacts and locations

Locations

  • Advanced Memory Research Institute of NJ /ID# 239533

    Toms River, New Jersey, 08755-5043, United States

  • Allied Biomedical Res Inst Inc /ID# 244823

    Miami, Florida, 33155, United States

  • Alzheimer's Research and Treatment Center - Stuart /ID# 245477

    Stuart, Florida, 34997-5765, United States

  • Alzheimer's Research and Treatment Center - Wellington /ID# 245201

    Wellington, Florida, 33414, United States

  • Artemis Institute for Clinical Research - San Diego /ID# 244508

    San Diego, California, 92103-2204, United States

  • Aventura Neurological Associates /ID# 243892

    Aventura, Florida, 33180, United States

  • Charter Research - Lady Lake /ID# 244657

    Lady Lake, Florida, 32162, United States

  • Charter Research - Winter Park /ID# 244778

    Orlando, Florida, 32803-1839, United States

  • ClinCloud - Maitland /ID# 244507

    Maitland, Florida, 32751, United States

  • ClinCloud LLC - Viera/Melbourne /ID# 240635

    Melbourne, Florida, 32940-8288, United States

  • Clinical Site Partners (CSP) - Orlando /ID# 245127

    Winter Park, Florida, 32789-4681, United States

  • Clinical Trials of Texas, Inc /ID# 244917

    San Antonio, Texas, 78229, United States

  • Columbus Memory Center /ID# 245054

    Columbus, Georgia, 31909, United States

  • Conquest Research /ID# 243916

    Winter Park, Florida, 32789, United States

  • Finlay Medical Research /ID# 245996

    Miami, Florida, 33126, United States

  • Headlands Research - Orlando /ID# 239119

    Orlando, Florida, 32819, United States

  • IMIC Inc. Medical Research /ID# 245900

    Palmetto Bay, Florida, 33157, United States

  • Irvine Clinical Research /ID# 239469

    Irvine, California, 92614, United States

  • JEM Research Institute /ID# 239122

    Lake Worth, Florida, 33462-1141, United States

  • K2 Medical Research - Ocoee /ID# 246849

    Ocoee, Florida, 34761-4547, United States

  • K2 Medical Research - Orlando - South Orlando Avenue /ID# 243919

    Orlando, Florida, 32751, United States

  • Keystone Clinical Studies LLC /ID# 239973

    Plymouth Meeting, Pennsylvania, 19462, United States

  • Merritt Island Medical Research /ID# 239495

    Merritt Island, Florida, 32952-3616, United States

  • Neurology Associates Ormond Beach /ID# 245527

    Ormond Beach, Florida, 32174, United States

  • Optimus U /ID# 245868

    Miami, Florida, 33125-4013, United States

  • Pacific Research Network, Inc. /ID# 244083

    San Diego, California, 92103, United States

  • Premiere Research Institute - Palm Beach /ID# 240108

    West Palm Beach, Florida, 33407-3209, United States

  • QUEST Research Institute /ID# 239459

    Farmington Hills, Michigan, 48334-2977, United States

  • Re:Cognition Health - Fairfax VA /ID# 239501

    Fairfax, Virginia, 22031-5207, United States

  • Renstar Medical Research /ID# 240153

    Ocala, Florida, 34470, United States

  • Syrentis Clinical Research /ID# 239682

    Santa Ana, California, 92705, United States

  • Tucson Neuroscience Research /ID# 244957

    Tucson, Arizona, 85710-6152, United States

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