Not Yet Enrolling

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

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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
60
Trial Dates
Jun 2024 - Feb 2027
How long will I be in the trial?
The study will last up to approximately 69 weeks for Part A, and, if conducted, 73 weeks for Part B. If conducted, the optional bridging period for Part A participants would last up to approximately 1 year after their completion of Part A
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 Disease and Memory Loss Research Studies

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

Learn More

Neurodegenerative Disease Research

To learn more about neurodegenerative diseases and clinical trials being carried out in the area, visit our Neurodegenerative Disease Research page.

Clinical Trial Participation: What to Expect

A clinical trial is a scientific study. It helps us learn if a new medicine or treatment works and how it works. Clinical trials can also be called clinical research studies. Learn more about clinical research studies and what to expect when taking part in a clinical trial.