RecruitingPhase 1NCT06297590

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


Sponsor

Eli Lilly and Company

Enrollment

48 participants

Start Date

Aug 15, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 50 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This first-in-human study tests a new experimental drug, LY3954068, in people with early symptomatic Alzheimer's disease to evaluate its safety, how it behaves in the body, and early signs of whether it may slow disease progression. **You may be eligible if...** - You have experienced gradual memory decline for at least 6 months - Your memory and thinking tests show mild impairment (MMSE score 18–30, CDR score 0.5–1.0) - A brain scan (PET) confirms the presence of tau protein — a hallmark of Alzheimer's - You have a study partner (such as a family member or friend) who spends at least 10 hours a week with you and can attend appointments - You meet the BMI requirements (18–40 kg/m²) **You may NOT be eligible if...** - You have other serious medical conditions (heart, liver, kidney, lung, or neurological disease other than Alzheimer's) - You are allergic to flortaucipir (the PET scan tracer used) - You have a contraindication to MRI (such as a metal implant or claustrophobia) - Your life expectancy is less than 24 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLY3954068

Administered IT

DRUGPlacebo

Administered IT

DRUGFlortaucipir F18

Administered intravenously (IV) prior to Positron Emission Tomography (PET) scan


Locations(10)

K2 Medical Research, LLC

Maitland, Florida, United States

Charter Research, LLC

The Villages, Florida, United States

CenExel iResearch, LLC (CenExel iRA)

Decatur, Georgia, United States

Massachusetts General Hospital (MGH)

Charlestown, Massachusetts, United States

CenExel AMRI

Toms River, New Jersey, United States

Duke University

Durham, North Carolina, United States

The University of Tokyo Hospital

Bunkyō City, Japan

National Hospital for Neurology and Neurosurgery (UCLH)

London, United Kingdom

Royal Hallamshire Hospital

Sheffield, United Kingdom

University Hospital Southampton

Southampton, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06297590


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