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New treatment option for Alzheimer Disease
Official title A Study of LY3439539 in Participants With Alzheimer's Disease
ClinicalTrials.gov ID: NCT07598370
What this study is testing
What is LY3439539?
LY3439539 is an investigational medicine, given as a monthly infusion into a vein, being studied as a potential treatment for alzheimer disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 85
You may be able to join if
- Have gradual and progressive change in memory function reported by the participant or informant for 6 months or longer consistent with a diagnosis of...
- 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.
You likely can't join if
- Have any contraindications for magnetic resonance imaging (MRI), including claustrophobia or the presence of contraindicated metal (ferromagnetic)...
- 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
See the full eligibility 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).
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Irvine, California, United States
- Adelaide, Australia
- Birtinya, Australia
- Ivanhoe, Australia
- Kogarah, Australia
- Macquarie University, Australia
- Melbourne, Australia
- Christchurch, New Zealand
- Singapore, Singapore
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Irvine, California, United States; Adelaide, Australia; Birtinya, Australia; Ivanhoe, Australia; Kogarah, Australia; Macquarie University, Australia and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.