A First-In-Human Study of LY3954068 in Participants With Early Symptomatic Alzheimer's Disease

Launched by ELI LILLY AND COMPANY · Mar 1, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new drug called LY3954068 to see if it is safe for people with early symptoms of Alzheimer’s Disease (AD). The main goals are to check how safe the drug is, how much of it enters the bloodstream, and its effects on markers related to Alzheimer’s. The trial has two parts: in Part A, participants will receive either LY3954068 or a placebo (a substance without any active drug) through a spinal injection. If they continue to Part B, they'll get two doses of either the drug or placebo. The entire process may last up to 45 weeks for Part A and 73 weeks for Part B, with a chance for some participants to join an additional study afterward.

To be eligible, participants must be between 18 and 85 years old, have noticeable memory changes for at least six months, and meet specific assessments for memory and dementia. They should also have someone who can support and attend appointments with them. However, individuals with certain serious health conditions or prior treatments that may interfere with the study cannot participate. If you or a loved one is interested, this trial could offer insight into a potential new treatment for Alzheimer’s, while closely monitoring safety and effects.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Have a body mass index (BMI) within the range 18 (17 for Japan participants) to 40 kilograms per square meter (kg/m²), inclusive, at screening.
• • Have gradual and progressive change in memory function for greater than or equal to (≥) 6 months as reported by the participant or informant.
• • Have a mini mental state examination (MMSE) score of 18 to 30 at screening.
• • Have a clinical dementia rating (CDR) global score of 0.5 to 1.0, with a memory box score ≥ 0.5 at screening.
• • Meet flortaucipir F18 positron emission tomography (PET) criteria, as defined in the TAUVID™ FDA label (TAUVID™ prescribing information, 2024), demonstrating evidence of tau pathology.
• • Males who agree to follow contraceptive requirements, or women not of childbearing potential (WNOCBP).
• • Participants must have up to 2 study partners who are with contact with the participant at least 10 hours per week and one of whom can attend study appointments.
• Exclusion Criteria:
• • Has current serious or unstable illnesses including cardiovascular, hepatic, renal, gastroenterological, respiratory, endocrinologic, neurologic (other than Alzheimer's Disease), psychiatric, immunologic, or hematologic disease and other conditions that, in the investigator's opinion, could interfere with the analyses in this study; or has a life expectancy of less than (\<)24 months.
• • Have a sensitivity to flortaucipir F18.
• • Have contraindication to magnetic resonance imaging (MRI), including claustrophobia or the presence of contraindicated metal (ferromagnetic) implants/cardiac pacemaker.
• • Have a current exposure to an amyloid targeted therapy (ATT). 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 previous exposure to any Investigational Medicinal Product administered intrathecal (IT) or previous exposure to any anti-tau therapy.
• • Have a history of clinically significant back pain, back pathology and/or back injury (for example, degenerative disease, spinal deformity or spinal surgery) that may predispose to complications or technical difficulty with lumbar puncture.