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RecruitingPhase 1

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
50 Years to 85 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 9 visits

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participation in the study will last approximately 9 months with visits about once a month."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how LY3439539 affects certain proteins in the spinal fluid of people with Alzheimer's disease. Taking part lasts about 9 months, with visits about once a month.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have memory loss that has slowly worsened for at least 6 months and fits a diagnosis of dementia due to Alzheimer's disease. You or someone who knows you must report this change.
  • Score 16 to 24 on the Mini Mental State Examination, a test of memory and thinking.
  • Meet the study's rules for blood levels of pTau, a protein.
  • Have a body mass index (BMI), a measure based on height and weight, of 17 to 32 at screening.
  • Be a woman who cannot become pregnant, or a man willing to use effective birth control throughout the study.
  • Have had enough reading ability before the illness, and have enough vision and hearing to complete study tasks.
  • Have 1 or 2 study partners who are in frequent contact with you, at least 10 hours each week.

Who can't join

  • Cannot safely have an MRI scan, including because of fear of tight spaces or certain metal implants or pacemakers, or have a screening MRI showing a major abnormality.
  • Have a history of suicidal behavior, any past suicide attempt, or an immediate risk of suicide.
  • Have a history of severe or ongoing allergic reactions; reactions to vaccines or immune proteins; 2 or more serious drug allergies; or trouble tolerating steroid skin treatments or severe reactions after treatment.
  • Have a serious or unstable illness, including diseases of major organs, blood, hormones, or the immune system, mental illness, or a brain or nerve illness other than Alzheimer's disease.
  • Need another monoclonal antibody treatment, a type of protein-based medicine, or recently received a biologic medicine. The waiting period is 3 months or 5 half-lives, whichever is longer. A half-life is the time it takes the amount of medicine in the body to drop by half.
  • Cannot have a lumbar puncture, a procedure that takes a sample of spinal fluid.
  • Are in another study testing a product, or other medical research judged not to fit with this study.
  • Currently receive treatment targeting amyloid, a protein. Past treatment may be allowed if the last dose was more than 1 year ago, with approval from the study doctor in consultation with the sponsor.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 sites (8)

CA

FL

MI