A Study of LY4006895 in Healthy Participants With Early Symptomatic Alzheimer's Disease (AD)

Launched by ELI LILLY AND COMPANY · Oct 23, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new study drug called LY4006895 to see how safe it is and how well it works in people with early symptoms of Alzheimer's disease (AD) and healthy participants. The study has two parts: in Part A, healthy volunteers will receive a single dose of the drug, while in Part B, participants with early symptomatic AD will take multiple doses. The researchers will monitor how much of the drug enters the bloodstream and how long it stays in the body. This trial will take about 29 weeks for healthy participants and around 61 weeks for those with Alzheimer's, including time for screening before the study begins.

To be eligible for this study, participants must be generally healthy or have early symptoms of Alzheimer's, such as noticeable memory changes for at least six months. They should also have a specific score on a memory test. It's important to note that participants will need to have reliable study partners who can attend visits and provide support throughout the trial. Overall, participants can expect regular check-ups and blood tests to ensure their safety while taking the study drug. Those interested should also be aware that there are specific health conditions and medications that may exclude them from participating, so discussing any concerns with a healthcare provider is essential.

Gender

ALL

Eligibility criteria

• Inclusion Criteria for Part A and Part B:
• • Are overtly healthy as determined by medical evaluation. Rescreening is not allowed in this study
• • Have a body mass index (BMI) within the range 18 to 40 kilogram per square meter (kg/m²)
• For Part A:
• * Have early symptomatic AD, as defined by:
• • Gradual and progressive change in memory function for at least 6 months, as reported by the participant or informant
• • A Mini-Mental State Exam (MMSE) score of 18 to 30 at screening
• • A Clinical Dementia Rating (CDR) global score of 0.5 to 1.0 (inclusive), with a memory box score greater than or equal to 0.5 at screening
• For Part B:
• • Have up to 2 reliable study partners who are in frequent contact with the participant (defined as at least 10 hours per week), one of whom at any one occasion: will accompany the participant to the study visits, will be available by telephone at designated times, and will provide a separate written informed consent to participate
• Exclusion Criteria for Part A and Part B:
• • Current serious or unstable illnesses including cardiovascular, hepatic, renal, gastroenterological, respiratory, endocrinologic, neurologic (MAD: other than AD), psychiatric, immunologic, or hematologic disease and other conditions that, in the investigator's opinion, could interfere with the participant's ability to complete the study; or has a life expectancy of less than 24 months
• • Have screening hemoglobin (Hb) less than 12 grams per deciliter (g/dL) or evidence of iron-deficiency (ferritin less than 30 nanograms per milliliter (ng/mL), or presence/history of hemoglobinopathy
• • Are, in the judgment of the investigator, actively suicidal and therefore deemed to be at significant risk for suicide
• • Regularly use known drugs of abuse and/or show positive findings on urinary drug screening that cannot be explained by regular concomitant medications
• • Have previous exposure to any anti-tau therapy
• • Are pregnant or intend to become pregnant or to breastfeed during the study
• For Part B:
• • Have a current exposure to an amyloid targeted therapy. Prior exposure to amyloid targeted therapies greater than 1 year from the last dose may be permitted at the discretion of the investigator and in consultation with the sponsor. A listing of amyloid targeted therapies will be provided
• • Have a sensitivity to florataucipir 18F
• • Have contraindication to magnetic resonance imaging (MRI) including claustrophobia or the presence of contraindicated metal (ferrogmagnetic) implants/cardiac pacememaker