Clinical Trials in the USA / NCT07598370
Recruiting
Phase 1
A Study of LY3439539 in Participants With Alzheimer's Disease
NCT07598370 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Alzheimer Disease
Investigational drug(s) / intervention(s)
LY3439539
LY3439539: Administered IV
Study summary
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.
Eligibility
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.
Primary outcome measure(s)
- Change from Baseline in Cerebrospinal Fluid (CSF) Neurofilament Light Chain (NfL) — Baseline through end of the Follow-up Period (Week 24)
Trial sites (16)
| Facility | City | Region | Status |
|---|---|---|---|
| Irvine Clinical Research | Irvine | California | Recruiting |
| Healthy Brain Clinic | Long Beach | California | Recruiting |
| Inglewood Clinical | Los Angeles | California | Recruiting |
| Oakland Clinical | Oakland | California | Recruiting |
| K2 Medical Research - The Villages | Lady Lake | Florida | Not Yet Recruiting |
| K2 Medical Research | Maitland | Florida | Recruiting |
| Charter Research | Orlando | Florida | Not Yet Recruiting |
| AdventHealth Orlando | Orlando | Florida | Not Yet Recruiting |
| QUEST Research Institute | Farmington Hills | Michigan | 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 |
More Eli Lilly and Company trials in the USA
Other trials for the same condition
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Clinical Trial on Agitation in Alzheimer's Dementia
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07598370 on ClinicalTrials.gov ↗ ← All trials in the USA