Testing LY3954068 for early Alzheimer's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the safety and pharmacokinetics of LY3954068 in participants with early symptomatic Alzheimer's Disease. It consists of two parts: Part A involves administering a single dose of LY3954068 or a placebo into the spinal fluid, while Part B, which is optional, may include two additional doses. The study will last approximately 45 weeks for Part A and up to 73 weeks for Part B, including screening. Participants will also be monitored for effects on Alzheimer's disease markers.

Why it matters

Who can join: the full rules

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.

Where it's running

• K2 Medical Research, LLC
  Maitland, Florida, United States Recruiting
• Charter Research, LLC
  The Villages, Florida, United States Recruiting
• CenExel iResearch, LLC (CenExel iRA)
  Decatur, Georgia, United States Recruiting
• CenExel AMRI
  Toms River, New Jersey, United States Recruiting
• Duke University
  Durham, North Carolina, United States Recruiting
• The University of Tokyo Hospital
  Bunkyō City, Japan Recruiting

Study contacts

• Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
• Email: LillyTrials@Lilly.com
• Phone: 1-317-615-4559

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.