Tests LY3439539 effects on spinal fluid proteins in Alzheimer's disease
Studies how LY3439539 affects certain proteins in spinal fluid of people with Alzheimer's.
Plain-language title generated from the registry record
Registry title: A Study of LY3439539 in Participants With Alzheimer's Disease
Key facts
- Where
- Farmington Hills, Irvine, Lady Lake, Long Beach, Los Angeles, Maitland, Oakland, and Orlando, United StatesSee the 9 sites
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 50 and 85 years old?
Source: NCT07598370, who can take part
Where in United States
- QUEST Research InstituteFarmington Hills, United StatesTaking people
- Irvine Clinical ResearchIrvine, United StatesTaking people
- K2 MEDICAL Research THE VILLAGESLady Lake, United StatesNot yet recruiting
- Healthy Brain ClinicLong Beach, United StatesTaking people
- Inglewood ClinicalLos Angeles, United StatesTaking people
- K2 Medical ResearchMaitland, United StatesTaking people
- Oakland ClinicalOakland, United StatesTaking people
- AdventHealth OrlandoOrlando, United StatesNot yet recruiting
- Charter ResearchOrlando, United StatesNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Eli Lilly and Company
- Trial code
- NCT07598370
- Record updated
- 4 November 2026
- Original description
The purpose of this study is to see how LY3439539 affects certain proteins found in the spinal fluid of participants with Alzheimer's disease.Read full original descriptionShow less
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
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.
Inclusion: 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: 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; 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; Have any contraindications for magnetic resonance imaging (MRI), including claustrophobia or the presence of contraindicated metal (ferromagnetic) implants/cardiac pacemaker; 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; Have a screening MRI that shows evidence of significant abnormality; Have criteria that would preclude a lumbar puncture (LP).