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RecruitingPhase 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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
50 Years to 85 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 45 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The study will last up to approximately 45 weeks for Part A, and 100 weeks for Part B, including the screening period."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety of LY3954068 in people with early Alzheimer's disease symptoms. It also checks how much drug enters the blood and how it affects signs of the disease in the body. Participants receive the drug or a placebo (no active drug) into the fluid around the spinal cord.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have a BMI (a measure of weight compared with height) from 18 to 40.
  • Have memory problems that have slowly worsened for at least 6 months, reported by you or someone who knows you.
  • Score 18 to 30 on the MMSE, a test of memory and thinking.
  • Have a CDR score of 0.5 to 1.0 and a memory score of at least 0.5. These scores rate memory problems and daily function.
  • Have a special brain scan that meets study rules and shows buildup of a protein called tau.
  • Men must agree to follow birth control rules. Women must not be able to become pregnant.
  • Have study partners (up to 2) who are in contact with you at least 10 hours a week. At least one must be able to attend study visits.

Who can't join

  • Have a serious or unstable illness that the study doctor thinks could affect the study, or are expected to live less than 24 months.
  • Have a sensitivity to flortaucipir F18, the substance used for the brain scan.
  • Cannot have an MRI scan, such as because of fear of enclosed spaces or certain metal implants or heart pacemakers.
  • Currently receive treatment targeting amyloid, a protein linked to Alzheimer's. Past treatment may be allowed if the last dose was over a year ago, after review by the study doctor and sponsor.
  • Have ever received an experimental drug into spinal fluid or any treatment targeting tau.
  • Have a history of major back pain, back disease, or back injury that could make a spinal tap difficult or risky. A spinal tap uses a needle to reach spinal fluid.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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.

Study sites (6)

FL

GA

MA

NC

NJ