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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559
clinical_inquiry_hub@lilly.com


Study Location:

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Be Part of Research - Trial Details - A First-In-Human Study of LY3954068 in Participants With Early Symptomatic Alzheimer's Disease

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

Recruiting

Open to: ALL

Age: 50.0 - 85.0

Medical Conditions

Alzheimer Disease


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


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. Part B is optional, and participants from Part A may also have the opportunity to join an optional bridging period to a separate potential study where participants would receive LY3954068. Each enrolled participant in Part A will receive a single dose of LY3954068 or placebo (no active drug) given into the spinal fluid. If conducted, each participant in Part B would receive 2 doses of either LY3954068 or placebo administered into the spinal fluid.

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.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Aug 2024 Feb 2027

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : Administered IT

Intervention Arm Group : LY3954068 (Optional Part B);LY3954068 (Part A);

Intervention Type : DRUG
Intervention Description : Administered IT

Intervention Arm Group : Placebo (Optional Part B);Placebo (Part A);

Intervention Type : DRUG
Intervention Description : Administered intravenously (IV) prior to Positron Emission Tomography (PET) scan

Intervention Arm Group : LY3954068 (Optional Part B);LY3954068 (Part A);Placebo (Optional Part B);Placebo (Part A);



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Royal Hallamshire Hospital
    Sheffield
    S10 2JF
  • University Hospital Southampton
    Southampton
    SO16 6YD
  • National Hospital for Neurology and Neurosurgery (UCLH)
    London
    WC1N 3BG

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559
clinical_inquiry_hub@lilly.com



The study is sponsored by Eli Lilly and Company




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Read full details for Trial ID: NCT06297590
Last updated 17 April 2025

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