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A Study of LY3439539 in Participants With Alzheimer's Disease

NCT ID: NCT07598370
Registry status: Recruiting
Study type: Interventional
Phase: Phase 1
Sponsor: Eli Lilly and Company
Conditions: Alzheimer Disease

Overview

ClinicalTrials.gov lists this study as Recruiting.

Official title: 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

Enrollment: 30 participants (Estimated).

What is being studied

Drug: LY3439539

Who may be eligible

Ages: 50 Years to 85 Years
Sex: All
Healthy volunteers accepted: No

ClinicalTrials.gov lists the following 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.

Study locations

15 study locations are listed.

Recruiting site status is explicitly provided for 15 locations; 5 are listed as Recruiting.

Countries: Australia, New Zealand, Singapore, United States

California, United States: 4
Florida, United States: 3
Michigan, United States: 1

Sample of listed locations

Austin Health - Heidelberg Repatriation Hospital — Ivanhoe, 3079, Australia — Recruiting
Southern Neurology — Kogarah, 2217, Australia — Recruiting
Macquarie University Hospital — Macquarie University, 2109, Australia — Recruiting
The Alfred — Melbourne, 3004, Australia — Recruiting
Lilly Centre for Clinical Pharmacology — Singapore, 138623, Singapore — Recruiting
Flinders Medical Centre — Adelaide, 5042, Australia — Not yet recruiting
Christchurch Neurology Trials — Christchurch, 8011, New Zealand — Not yet recruiting
Irvine Clinical Research — Irvine, California, 92614, United States — Not yet recruiting
Healthy Brain Clinic — Long Beach, California, 90804, United States — Not yet recruiting
Inglewood Clinical — Los Angeles, California, 90056, United States — Not yet recruiting
Oakland Clinical — Oakland, California, 94609, United States — Not yet recruiting
K2 Medical Research — Maitland, Florida, 32751, United States — Not yet recruiting
AdventHealth Orlando — Orlando, Florida, 32804, United States — Not yet recruiting
Charter Research — Orlando, Florida, 32803, United States — Not yet recruiting
QUEST Research Institute — Farmington Hills, Michigan, 48334, United States — Not yet recruiting

Study details

Start date: May 21, 2026
Primary completion date: August 1, 2027
Completion date: August 1, 2027
First posted: May 20, 2026

Source and update information

Source: ClinicalTrials.gov
NCT ID: NCT07598370
Registry last updated: September 24, 2026
QualifiedStudies registry data refreshed: September 28, 2026
QualifiedStudies record fetched: September 28, 2026

View NCT07598370 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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