Testing LY3954068 for early Alzheimer's disease
A Single- and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3954068 in Patients With Early Symptomatic Alzheimer's Disease
This study is testing a new drug called LY3954068 to see if it is safe and how it works in people with early Alzheimer's disease.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 50 Years to 85 Years |
| Sex | All |
| Sponsor | Eli Lilly and Company Industry-sponsored |
| Locations | 10 sites (Maitland, Florida and 9 other locations) |
| Trial ID | NCT06297590 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the safety and pharmacokinetics of LY3954068 in participants with early symptomatic Alzheimer's Disease. It consists of two parts: Part A involves administering a single dose of LY3954068 or a placebo into the spinal fluid, while Part B, which is optional, may include two additional doses. The study will last approximately 45 weeks for Part A and up to 73 weeks for Part B, including screening. Participants will also be monitored for effects on Alzheimer's disease markers.
Who should consider this trial
Good fit: Ideal candidates are adults with early symptomatic Alzheimer's disease, showing progressive memory decline and meeting specific cognitive and imaging criteria.
Not a fit: Patients with severe cognitive impairment or those not meeting the eligibility criteria will likely not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new treatment options for patients with early Alzheimer's disease.
How similar studies have performed: Other studies targeting tau pathology in Alzheimer's disease have shown promise, suggesting potential for success with this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Have a body mass index (BMI) within the range 18 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.
Where this trial is running
Maitland, Florida and 9 other locations
- K2 Medical Research, LLC — Maitland, Florida, United States (Recruiting)
- Charter Research, LLC — The Villages, Florida, United States (Recruiting)
- CenExel iResearch, LLC (CenExel iRA) — Decatur, Georgia, United States (Recruiting)
- Massachusetts General Hospital (MGH) — Charlestown, Massachusetts, United States (Not_yet_recruiting)
- CenExel AMRI — Toms River, New Jersey, United States (Recruiting)
- Duke University — Durham, North Carolina, United States (Recruiting)
- The University of Tokyo Hospital — Bunkyō City, Japan (Recruiting)
- National Hospital for Neurology and Neurosurgery (UCLH) — London, United Kingdom (Recruiting)
- Royal Hallamshire Hospital — Sheffield, United Kingdom (Not_yet_recruiting)
- University Hospital Southampton — Southampton, United Kingdom (Not_yet_recruiting)
Study contacts
- Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
- Email: LillyTrials@Lilly.com
- Phone: 1-317-615-4559
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.