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Taking people in JapanPhase 1

Tests LY3954068 safety in people with early Alzheimer's disease

Tests LY3954068 injected into the spinal fluid in people with early Alzheimer's disease.

Key facts

Who runs it
Eli Lilly and Company
Where
Bunkyō City, JapanSee the siteAlso in 2 other countries, 9 sites
Trial code
Registry title
A First-In-Human Study of LY3954068 in Participants With Early Symptomatic Alzheimer's Disease
Status
Recruiting
Phase
Phase 1
People taking part
56 people, planned
Started
15 Aug 2024
Expected to end
Jul 2028
Type of study
Interventional, 4 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • LY3954068
  • Placebo
  • Flortaucipir F18
Record updated
29 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 50 to 85 with early symptomatic Alzheimer's disease and signs of tau pathology on a PET scan.

Age
50 to 85 years
Sex
Men and women
Disease stage
Early symptomatic Alzheimer's disease: memory worsening gradually for 6 months or more, MMSE score 18 to 30, CDR global score 0.5 to 1.0.
Earlier treatment
Current amyloid targeted therapy is not allowed. Earlier amyloid therapy more than 1 year after the last dose may be allowed. No earlier anti-tau therapy or intrathecal investigational drug.
Biomarker or test result
Evidence of tau pathology on a flortaucipir F18 PET scan, as defined in the TAUVID label.

Main reasons for not taking part

  • Serious or unstable illness that could interfere with the study, or life expectancy under 24 months
  • Sensitivity to flortaucipir F18
  • Cannot have an MRI, for example claustrophobia or metal implants or a pacemaker
  • Clinically significant back pain, back disease or back injury that could complicate a lumbar puncture
  • Previous anti-tau therapy or investigational drug given into the spinal fluid

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Check if you might fit

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?

Where in Japan

Also in 2 other countries, 9 sites

  • The University of Tokyo HospitalBunkyō City, JapanContact: Yoshiki Niimi (principal investigator)Taking people

About the trial

What the trial wants to find out

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

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.

The 4 groups in the trial

  • LY3954068 (Part A)Treatment being tested

    Single ascending dose of LY3954068 administered intrathecally (IT)

    Treatment: LY3954068 and Flortaucipir F18

  • Placebo (Part A)Placebo, for comparison

    Single ascending dose of placebo administered IT

    Treatment: Placebo and Flortaucipir F18

  • LY3954068 (Part B)Treatment being tested

    Multiple ascending dose of LY3954068 administered IT

    Treatment: LY3954068 and Flortaucipir F18

  • Placebo (Part B)Placebo, for comparison

    Multiple ascending dose of placebo administered IT

    Treatment: Placebo and Flortaucipir F18

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
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
Plain-language title
Tests LY3954068 safety in people with early Alzheimer's diseaseGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT06297590, who can take part
Record updated
29 October 2026