Can new drugs clear Alzheimer's brain plaques?

NCT ID NCT07787169

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 26, 2026 · Last updated Aug 28, 2026 · Updated 2 times

Summary

This master protocol supports several early-phase studies testing different amyloid-targeting drugs in healthy volunteers and people with Alzheimer's disease. The main goals are to check safety and tolerability, and to see whether these drugs can remove amyloid plaques from the brain. Participants will be assigned to one of two substudies, receiving either the experimental drug or a placebo, given by injection or infusion.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
LY4405094 (an experimental amyloid-targeting drug) and placebo, given intravenously or subcutaneously, with amyloid imaging agents
What this could lead to
If successful, this could point toward a new treatment that clears amyloid plaques from the brain, potentially slowing Alzheimer's disease.
What could go wrong
This is an early-phase trial focused on safety and dosing, so the drug may not effectively clear plaques or improve symptoms. Side effects are possible, and results may not generalize to all patients.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 179 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jul 2028

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

18 to 85 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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.

Participants must meet eligibility criteria below. Additional criteria are specified in the substudy to which the participant will enroll. Inclusion Criteria for Healthy Participants: * Are between 18 and 45 years of age * Have a body mass index (BMI) of 18.0 to 32.0 kilograms per square meter (kg/m²) * Are overtly healthy as determined by medical evaluation, including medical history, physical examination, and electrocardiograms (ECGs). Inclusion Criteria for Participants with Alzheimer's Disease (AD): * Are between 55-85 years of age * Have gradual and progressive changes in memory function, as reported by the participant or their study partner, for greater than or equal to (≥) 6 months at screening, as well as a clinical diagnosis of mild cognitive impairment due to AD or mild-to-moderate AD dementia as determined by the investigator or based on medical history. * Have Mini-Mental State Exam (MMSE) score ≥16 * Have positive amyloid positron emission tomography (PET) * Have a reliable study partner who will provide written informed consent to participate and is in frequent contact with the participant. A second person may serve as backup. * For participants on symptomatic treatments for AD (for example, cholinesterase inhibitors, memantine) the dosing regimen must be stable, in the opinion of the investigator, for at least 8 weeks before randomization to a study intervention, and the dosing regimen is planned to remain stable. Exclusion Criteria for all Participants: * Have currently, or a history of, serious or unstable neurological or psychological disease (except for AD for participants in the AD cohorts). * Have currently, or a history of, significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological diseases. * Have currently, or a history of, allergies to monoclonal antibodies, diphenhydramine, epinephrine, or methylprednisolone. * Have currently, or a history of, clinically significant multiple or severe drug allergies or severe posttreatment hypersensitivity reactions. * Have currently, or a history of cancer within the past 5 years except for some early skin cancers that have been resected with no evidence of metastatic disease for 3 years. * Have received any amyloid-targeting therapy (ATT), whether marketed or investigational; or have received active immunization against amyloid beta (Aβ). * Have received an active study intervention, within the last 30 days, in a clinical study involving an IMP. * Are pregnant or breastfeeding or intend to become pregnant or to breastfeed during the study; * Have an abnormal blood pressure, pulse rate, or both, as determined by the investigator, or a preexisting history of hypertension. Exclusion Criteria for Healthy Participants: * Have a locally read brain magnetic resonance imaging (MRI) that demonstrates any clinically significant findings, including but not limited to, findings suggestive of CAA, that, in the opinion of the investigator, may impact the participant's ability to safely participate in the study. * Have a history of clinically significant back pain, pathological conditions of the back, or back injury (for example, degenerative disease, spinal deformity, or spinal surgery), or have a local infection at the intended site of the lumbar puncture (LP) that may predispose to complications or technical difficulty with LP. * Have a family history of early onset AD (AD diagnosed before 65 years of age). Exclusion Criteria for Participants with AD: * Contraindications or unable to tolerate MRI * Have a centrally read brain MRI that demonstrates the presence of Amyloid-Related Imaging Abnormalities with Edema/Effusion (ARIA-E), greater than (\>)4 cerebral microhemorrhages, any evidence of superficial siderosis, any macrohemorrhage, or severe white matter disease; \>2 lacunar infarcts or any territorial infarct \>1 square centimeters (cm²); significant abnormalities that suggest another potential etiology for progressive dementia, or clinically significant finding that, in the opinion of the investigator, may impact the participant's ability to safely participate in the study. * Contraindications to amyloid PET scan.

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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

    10 sites. 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

  • Accel Research Sites - NeuroStudies Clinical Research Unit

    Decatur, Georgia, 30030, United States

  • Charter Research

    Orlando, Florida, 32803, United States

  • Charter Research

    The Villages, Florida, 32162-2698, United States

  • Fortrea Clinical Research Unit

    Daytona Beach, Florida, 32117, United States

  • Irvine Clinical Research

    Irvine, California, 92614, United States

  • K2 Medical Research

    Maitland, Florida, 32751, United States

  • K2 Medical Research - Tampa

    Tampa, Florida, 33634, United States

  • K2 Medical Research - The Villages

    Lady Lake, Florida, 32159, United States

  • Progressive Medical Research

    Port Orange, Florida, 32127, United States

  • QUEST Research Institute

    Farmington Hills, Michigan, 48334, United States

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