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New drug targets Alzheimer's proteins in spinal fluid

NCT ID NCT07598370

Knowledge-focused Sponsor: Eli Lilly and Company Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 04, 2026 · Updated 4 times

Summary

This early-stage study is testing an experimental drug called LY3439539 in 30 people with mild-to-moderate Alzheimer's disease. The main goal is to see if the drug changes certain proteins in the spinal fluid that are linked to Alzheimer's. Participants will receive the drug through an IV and have monthly visits for about 9 months.

What this could mean

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

Active substance
LY3439539
What this could lead to
If successful, this could help researchers understand how LY3439539 affects Alzheimer's-related brain changes, potentially guiding future treatments.
What could go wrong
This is a very early, small Phase 1 study focused on biomarkers, not symptoms. It may not show any benefit, and the drug could have side effects.

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 30 people

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

Started

May 2026

Expected to finish

Aug 2027

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 85 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: * Have gradual and progressive change in memory function reported by the participant or informant for 6 months or longer consistent with a diagnosis of dementia due to Alzheimer's disease * Have a Mini Mental Score Examination score of 16 to 24, inclusive * Meet plasma pTau criteria, as defined by the sponsor * Have body mass index within the range of 17 and 32 kilograms per square meter (kg/m²) (inclusive) at screening * Are women not of childbearing potential and men willing to practice effective contraception throughout the study. * Have adequate premorbid literacy, vision, and hearing throughout the study duration and able to complete study procedures. * Have at least 1, and up to 2, study partners who are in frequent contact with the participant (defined as at least 10 hours per week). Exclusion Criteria: * Have any contraindications for magnetic resonance imaging (MRI), including claustrophobia or the presence of contraindicated metal (ferromagnetic) implants/cardiac pacemaker. * Have a screening MRI that shows evidence of significant abnormality. * Have history of suicidal behavior, or a lifetime history of suicide attempt or acute suicidality. * Have a history of * Severe or ongoing allergy or hypersensitivity reactions * Hypersensitivity to immunizations or immunoglobulins * Two or more clinically significant or severe drug allergies, * Intolerance to topical corticosteroids or severe posttreatment hypersensitivity reactions * Have current serious or unstable illnesses, including hepatic, renal, gastroenterological, respiratory, cardiovascular, neurologic (other than AD), psychiatric, endocrinologic, immunologic, hematologic disease, or other conditions * Require treatment with another monoclonal antibody or have received treatment with biologic agents (such as monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to dosing. * Have criteria that would preclude a lumbar puncture (LP). * Are currently enrolled in a clinical study involving an investigational product (IP) or any other type of medical research judged not to be scientifically or medically compatible with this study. * Have a current exposure to amyloid-targeting therapies (ATTs). Prior exposure to ATTs greater than 1 year from the last dose may be permitted at the discretion of the investigator and in consultation with the sponsor.

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Conditions

The condition(s) this trial relates to.

Alzheimer disease Cognitive Dysfunction dementia neurodegenerative disease

As listed by the trial registrant

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

Alzheimer disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    11 sites in 4 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

  • Austin Health - Heidelberg Repatriation Hospital

    RECRUITING

    Ivanhoe, 3079, Australia

  • Charter Research

    NOT_YET_RECRUITING

    Orlando, Florida, 32803, United States

  • Christchurch Neurology Trials

    NOT_YET_RECRUITING

    Christchurch, 8011, New Zealand

  • Flinders Medical Centre

    NOT_YET_RECRUITING

    Adelaide, 5042, Australia

  • Healthy Brain Clinic

    NOT_YET_RECRUITING

    Long Beach, California, 90804, United States

  • Inglewood Clinical

    NOT_YET_RECRUITING

    Los Angeles, California, 90056, United States

  • Irvine Clinical Research

    NOT_YET_RECRUITING

    Irvine, California, 92614, United States

  • Lilly Centre for Clinical Pharmacology

    RECRUITING

    Singapore, 138623, Singapore

  • Macquarie University Hospital

    RECRUITING

    Macquarie University, 2109, Australia

  • Southern Neurology

    RECRUITING

    Kogarah, 2217, Australia

  • The Alfred

    RECRUITING

    Melbourne, 3004, Australia

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