Tests LY3954068 safety in people with early Alzheimer's disease
Tests LY3954068 injected into the spinal fluid in people with early Alzheimer's disease.
Plain-language title generated from the registry record
Registry title: A First-In-Human Study of LY3954068 in Participants With Early Symptomatic Alzheimer's Disease
Key facts
- Where
- Charlestown, Decatur, Durham, Maitland, The Villages, and Toms River, United StatesSee the 6 sites
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 50 and 85 years old?
Source: NCT06297590, who can take part
Where in United States
- Massachusetts General Hospital (MGH)Charlestown, United StatesNot yet recruiting
- CenExel iResearch, LLC (CenExel iRA)Decatur, United StatesTaking people
- Duke UniversityDurham, United StatesTaking people
- K2 Medical Research, LLCMaitland, United StatesTaking people
- Charter Research, LLCThe Villages, United StatesTaking people
- CenExel AMRIToms River, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Eli Lilly and Company
- Trial code
- NCT06297590EU 2024-510604-37-00
- Record updated
- 29 October 2026
- Original description
The main purpose of this study is to evaluate the safety of LY3954068 in participants with early symptomatic Alzheimer's Disease (AD). The study will also investigate how much LY3954068 gets into the bloodstream and will test the effects of LY3954068 on markers of AD.Read full original descriptionShow less
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
The main purpose of this study is to evaluate the safety of LY3954068 in participants with early symptomatic Alzheimer's Disease (AD). The study will also investigate how much LY3954068 gets into the bloodstream and will test the effects of LY3954068 on markers of AD.
The study will be comprised of two parts, A and B. Each enrolled participant in Part A will receive a single dose of LY3954068 or placebo (no active drug) given into the spinal fluid. Each participant in Part B will receive up to 4 doses of either LY3954068 or placebo administered into the spinal fluid. Participants may have the opportunity to join an optional bridging period to a separate potential study where participants would receive LY3954068.
The study will last up to approximately 45 weeks for Part A, and 100 weeks for Part B, including the screening period.
Inclusion: 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: 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; 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 contraindication to magnetic resonance imaging (MRI), including claustrophobia or the presence of contraindicated metal (ferromagnetic) implants/cardiac pacemaker; 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; Have a sensitivity to flortaucipir F18.