At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- LY3954068 (drug), Placebo (drug), Flortaucipir F18 (drug)
- How long the study runs
- Study runs about 30 months (dates as stated)
- About the drug or intervention
- LY3954068 — drug: Administered IT · Placebo — drug: Administered IT · Flortaucipir F18 — drug: Administered intravenously (IV) prior to Positron Emission Tomography (PET) scan
- Patient visit burden
- Not specified by the sponsor
In plain English
This is a first-in-human study of a new medicine called LY3954068 in people with early symptomatic Alzheimer's disease. It is run by Eli Lilly and Company. The study aims to test the medicine in people for the first time.
Who can take part
- Body mass index (a measure of weight for height) between 18 and 40 at screening
- Memory problems that have come on slowly and got worse over 6 months or more, as reported by the participant or someone who knows them well
- A mini mental state examination (a memory and thinking test) score of 18 to 30 at screening
- A clinical dementia rating (a measure of memory and thinking difficulties) global score of 0.5 to 1.0, with a memory box score of 0.5 or more at screening
- A flortaucipir F18 positron emission tomography (PET) scan (a special brain scan) showing evidence of tau, a protein linked to Alzheimer's disease
- Men must agree to follow contraception rules, or participants must be women who cannot become pregnant
- Up to 2 study partners who spend at least 10 hours a week with the participant, and one of whom can come to study appointments
Who may not be able to
- Serious or unstable illness (for example heart, liver, kidney, gut, breathing, hormone, nerve, mental health, immune or blood conditions), or a life expectancy of less than 24 months
- Sensitivity or allergy to flortaucipir F18 (the scan dye)
- Cannot have a magnetic resonance imaging (MRI) scan, for example due to claustrophobia, certain metal implants or a pacemaker
- Currently taking an amyloid targeted therapy (a treatment aimed at amyloid, a protein linked to Alzheimer's disease). Past use may be allowed if the last dose was over a year ago, at the researcher's and sponsor's discretion
- Previous treatment with any experimental medicine given by lumbar puncture (a needle into the lower back), or any anti-tau therapy
- A history of significant back pain, back problems, or back surgery that could make a lumbar puncture difficult or risky
What taking part involves
- • Not stated — ask the trial team
- • Brain scans including a flortaucipir F18 PET scan and MRI scans, based on the eligibility checks listed
- • A lumbar puncture appears to be part of the study, based on the back-health checks listed
Time commitment: Not stated — ask the trial team (the data does not say how many visits, how long the study lasts, or what taking part involves beyond scans and checks).
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 50 Years to 85 Years
- Who
- All
- Number of participants
- 48
- Started
- 2024-08-15
- Last checked
- 2026-08
Plain English Summary
What is this study?
- • Testing a new treatment for alzheimer disease
- • Phase1 - 48 participants
- • The main purpose of this study is to evaluate the safety of LY3954068 in participants with early symptomatic Alzheimer's Disease (AD)
Who can take part?
- • Ages 50 Years to 85 Years
- • Diagnosed with alzheimer disease
Where?
- • London - National Hospital for Neurology and Neurosurgery (UCLH)
- • Sheffield - Royal Hallamshire Hospital
- • Southampton - University Hospital Southampton
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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 2 doses of either LY3954068 or placebo administered into the spinal fluid. Participants will 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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 50 Years - 85 Years
- Who can join: All genders
What 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...
- ✓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™...
Who cannot take part
- ✗Have a sensitivity to flortaucipir F18.
- ✗Have safety concern to magnetic resonance imaging (MRI), including claustrophobia or the presence of...
- ✗Have previous exposure to any Investigational Medicinal Product administered intrathecal (IT) or previous exposure...
See the full criteria
Where Is This Study? (3 UK sites)
National Hospital for Neurology and Neurosurgery (UCLH)
London WC1N 3BG, United Kingdom
Royal Hallamshire Hospital
Sheffield S10 2JF, United Kingdom
University Hospital Southampton
Southampton SO16 6YD, United Kingdom
How to Get in Touch
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Sponsor contactCONTACT
Physicians interested in becoming principal investigators please contact
Sponsor contactCONTACT