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RECRUITING
NCT06297590
PHASE1

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

Sponsor: Eli Lilly and Company

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

50 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

48

Start Date

2024-08-15

Completion Date

2027-02

Last Updated

2026-03-12

Healthy Volunteers

No

Interventions

DRUG

LY3954068

Administered IT

DRUG

Placebo

Administered IT

DRUG

Flortaucipir 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