Not Yet Enrolling

A First-In-Human Study of LY3954068 in Participants With Early Symptomatic Alzheimer's Disease

J4T-MC-OLAA -

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.

Trial Summary

Age Range
50 - 85 years
Conditions the trial is for
Alzheimer's Disease
What the trial is testing?
LY3954068, Flortaucipir F18
Could I receive a Placebo?
Yes
Enrollment Goal
32
Trial Dates
Jul 1, 2024 - Feb 2027
How long will I be in the trial?
The study will last up to approximately 45 weeks for Part A, and, if conducted, 73 weeks for Part B, including the screening period. If the optional bridging period is conducted, participants in Part A could be enrolled in the separate potential study for up to approximately 96 weeks, including the screening period.
Trial Phase
I

Key Requirements

Clinical trials have inclusion and exclusion requirements to determine which individuals qualify for participation. Listed below are key requirements for this clinical trial, but there may be additional requirements to qualify.

Participants Must:

  • Have a gradual and progressive change in memory or ability to think and function for more than 6 months prior to screening

  • Have a family member or close friend who is with the participant at least 10 hours per week and can participate in study appointments

  • Have a mini mental state examination (MMSE) score of 18 to 30 at screening

  • Males who agree to follow contraceptive requirements, or women not of childbearing potential

Participants Must Not:

  • Have significant disease affecting the brain other than Alzheimer's Disease (AD) that could interfere with this study

  • Have other serious illnesses that could interfere with this study

  • Have certain health conditions that prevent them from getting an MRI or positron emission tomography (PET) scan

  • 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

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Clinical Trial Resources

Alzheimer's Research

To learn more about Alzheimer’s, memory loss and ongoing clinical trials in this area, visit our Alzheimer’s Disease Research page.

Learn More

Neurodegenerative Disease Research

To learn more about neurological disorders and ongoing clinical trials in the area, visit our Neurological Disorders Research page.

Clinical Trial Information

A clinical trial helps us learn if a new potential medicine or treatment works and how it works. Clinical trials are also called clinical research studies. To learn more about what to expect when taking part in a clinical trial, visit our Clinical Trial Information page.