RecruitingPhase 1NCT06657768

A Study of LY4006895 in Healthy Participants With Early Symptomatic Alzheimer's Disease (AD)

A Placebo-Controlled, Single- and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, PK and PD of LY4006895 in Healthy Volunteers and Patients With Early Symptomatic AD


Sponsor

Eli Lilly and Company

Enrollment

128 participants

Start Date

Oct 29, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The main purpose of this study is to evaluate the safety and tolerability of the study drug known as LY4006895. Part A will administer a single-ascending dose in healthy participants or Part B will administer multiple-ascending doses in participants with early symptomatic Alzheimer's Disease (AD). Blood tests will be performed to check how much LY4006895 gets into the bloodstream and how long it takes the body to eliminate it. This is a 2-part study and will last approximately 29 weeks for Part A and 61 weeks for Part B, including a screening period for each part.


Eligibility

Min Age: 45 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new investigational drug called LY4006895 in people who are otherwise healthy (Part B) and in people with early-stage Alzheimer's disease showing mild memory symptoms (Part A). Researchers want to understand how the drug behaves in the body and whether it is safe. **You may be eligible if...** - You are generally in good health - Your body mass index (BMI) is between 18 and 40 - For Part A: You have early Alzheimer's with gradual memory changes for at least 6 months, and your memory test scores fall within a mild-to-moderate range - You have a reliable person (study partner) who spends at least 10 hours per week with you and can attend visits **You may NOT be eligible if...** - You have serious heart, liver, kidney, or other significant health conditions - You have low hemoglobin (anemia) - You have a life expectancy of less than 24 months - You have neurological conditions other than Alzheimer's 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

DRUGLY4006895

Administered IV

DRUGPlacebo

Administered IV


Locations(9)

Collaborative Neuroscience Network - CNS

Los Alamitos, California, United States

K2 Medical Research - The Villages

Lady Lake, Florida, United States

K2 Medical Research

Maitland, Florida, United States

Atlanta Center of Medical Research

Atlanta, Georgia, United States

CenExel iResearch, LLC (CenExel iRA)

Decatur, Georgia, United States

CenExel-HRI

Marlton, New Jersey, United States

Duke Early Phase Research Unit

Durham, North Carolina, United States

The University of Tokyo Hospital

Bunkyō City, Japan

National Center for Geriatrics and Gerontology

Ōbu, Japan

View Full Details on ClinicalTrials.gov

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NCT06657768


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