NCT06297590RecruitingPhase 1
A First-In-Human Study of LY3954068 in Participants With Early Symptomatic 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
Source: ClinicalTrials.gov · Last updated 29 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 56 (estimated)
- First submitted
- 1 Mar 2024
- Start date
- 15 Aug 2024
- Primary completion date
- Jul 2028
- Lead sponsor
- Eli Lilly and Company
- Diseases
- Frontotemporal dementia, Alzheimer disease
- NCT number
- NCT06297590
- EU CT number
- 2024-510604-37-00
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 56
- From 15 Aug 2024 to the primary completion date, Jul 2028
- 10 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Other
- Have a sensitivity to flortaucipir F18.
Who the study is looking for
- 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.
Age in the registry: 50 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Hospital for Neurology and Neurosurgery (UCLH) Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Royal Hallamshire Hospital Coordinator of this site? Confirm its status | Sheffield | United Kingdom | Recruiting |
| University Hospital Southampton Coordinator of this site? Confirm its status | Southampton | United Kingdom | Recruiting |
| The University of Tokyo Hospital Coordinator of this site? Confirm its status | Bunkyō City | Japan | Recruiting |
| Massachusetts General Hospital (MGH) Coordinator of this site? Confirm its status | Charlestown | United States | Not yet recruiting |
| CenExel iResearch, LLC (CenExel iRA) Coordinator of this site? Confirm its status | Decatur | United States | Recruiting |
| Duke University Coordinator of this site? Confirm its status | Durham | United States | Recruiting |
| K2 Medical Research, LLC Coordinator of this site? Confirm its status | Maitland | United States | Recruiting |
| Charter Research, LLC Coordinator of this site? Confirm its status | The Villages | United States | Recruiting |
| CenExel AMRI Coordinator of this site? Confirm its status | Toms River | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.