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NCT07598370From ClinicalTrials.govRecruiting

A Study of LY3439539 in Participants With Alzheimer's Disease

A Phase 1, Open Label, Multiple-Dose Study to Assess the Changes in Cerebrospinal Fluid Biomarkers for Alzheimer's Disease Following Treatment With LY3439539 in Participants With Symptomatic Alzheimer's Disease

  • Alzheimer Disease

At a glance

Phase
Phase 1
Study type
Interventional
Sponsor
Eli Lilly and Company
Enrolment target
30
Started
21 May 2026
Main results due
August 2027
Study sites
15
Registry updated
24 September 2026

Can you take part?

  • Ages 50 years to 85 years.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
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.

What this study is about

In the sponsor’s own words, from the registry.

The purpose of this study is to see how LY3439539 affects certain proteins found in the spinal fluid of participants with Alzheimer's disease.

Participation in the study will last approximately 9 months with visits about once a month.

Study sites(15)

  • Irvine Clinical Research

    Irvine, California, United States

    Not yet recruiting

  • Healthy Brain Clinic

    Long Beach, California, United States

    Not yet recruiting

  • Inglewood Clinical

    Los Angeles, California, United States

    Not yet recruiting

  • Oakland Clinical

    Oakland, California, United States

    Not yet recruiting

  • K2 Medical Research

    Maitland, Florida, United States

    Not yet recruiting

  • Charter Research

    Orlando, Florida, United States

    Not yet recruiting

  • AdventHealth Orlando

    Orlando, Florida, United States

    Not yet recruiting

  • QUEST Research Institute

    Farmington Hills, Michigan, United States

    Not yet recruiting

  • Flinders Medical Centre

    Adelaide, Australia

    Not yet recruiting

  • Austin Health - Heidelberg Repatriation Hospital

    Ivanhoe, Australia

    Recruiting

  • Southern Neurology

    Kogarah, Australia

    Recruiting

  • Macquarie University Hospital

    Macquarie University, Australia

    Recruiting

  • The Alfred

    Melbourne, Australia

    Recruiting

  • Christchurch Neurology Trials

    Christchurch, New Zealand

    Not yet recruiting

  • Lilly Centre for Clinical Pharmacology

    Singapore, Singapore

    Recruiting

Showing 15 of 15 sites. 5 of the 15 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07598370. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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A Study of LY3439539 in Participants With Alzheimer's Disease | Trialion