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

Last updated: August 26, 2025
Sponsor: Eli Lilly and Company
Overall Status: Active - Recruiting

Phase

1

Condition

N/A

Treatment

Placebo

LY4006895

Clinical Study ID

NCT06657768
27263
J5K-MC-OQAA
  • Ages 45-85
  • All Genders
  • Accepts Healthy Volunteers

Study 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 Criteria

Inclusion

Inclusion Criteria for Part A and Part B:

  • Are overtly healthy as determined by medical evaluation. Rescreening is not allowed in this study

  • Have a body mass index (BMI) within the range 18 to 40 kilogram per square meter (kg/m²)

For Part A:

  • Have early symptomatic AD, as defined by:

  • Gradual and progressive change in memory function for at least 6 months, as reported by the participant or informant

  • A Mini-Mental State Exam (MMSE) score of 18 to 30 at screening

  • A Clinical Dementia Rating (CDR) global score of 0.5 to 1.0 (inclusive), with a memory box score greater than or equal to 0.5 at screening

For Part B:

  • Have up to 2 reliable study partners who are in frequent contact with the participant (defined as at least 10 hours per week), one of whom at any one occasion: will accompany the participant to the study visits, will be available by telephone at designated times, and will provide a separate written informed consent to participate

Exclusion Criteria for Part A and Part B:

  • Current serious or unstable illnesses including cardiovascular, hepatic, renal, gastroenterological, respiratory, endocrinologic, neurologic (MAD: other than AD), psychiatric, immunologic, or hematologic disease and other conditions that, in the investigator's opinion, could interfere with the participant's ability to complete the study; or has a life expectancy of less than 24 months

  • Have screening hemoglobin (Hb) less than 12 grams per deciliter (g/dL) or evidence of iron-deficiency (ferritin less than 30 nanograms per milliliter (ng/mL), or presence/history of hemoglobinopathy

  • Are, in the judgment of the investigator, actively suicidal and therefore deemed to be at significant risk for suicide

  • Regularly use known drugs of abuse and/or show positive findings on urinary drug screening that cannot be explained by regular concomitant medications

  • Have previous exposure to any anti-tau therapy

  • Are pregnant or intend to become pregnant or to breastfeed during the study

For Part B:

  • Have a current exposure to an amyloid targeted therapy. Prior exposure to amyloid targeted therapies greater than 1 year from the last dose may be permitted at the discretion of the investigator and in consultation with the sponsor. A listing of amyloid targeted therapies will be provided

  • Have a sensitivity to florataucipir 18F

  • Have contraindication to magnetic resonance imaging (MRI) including claustrophobia or the presence of contraindicated metal (ferrogmagnetic) implants/cardiac pacememaker

Study Design

Total Participants: 68
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 1
Study Start date:
October 29, 2024
Estimated Completion Date:
July 31, 2027

Connect with a study center

  • Collaborative Neuroscience Network - CNS

    Los Alamitos, California 90720
    United States

    Site Not Available

  • PRIM: CenExel - CNS

    Los Alamitos, California 90720
    United States

    Site Not Available

  • Collaborative Neuroscience Network - CNS

    Los Alamitos 5368304, California 5332921 90720
    United States

    Active - Recruiting

  • K2 Medical Research - The Villages

    Lady Lake, Florida 32159
    United States

    Site Not Available

  • K2 Medical Research

    Maitland, Florida 32751
    United States

    Site Not Available

  • K2 Medical Research - The Villages

    Lady Lake 4161118, Florida 4155751 32159
    United States

    Site Not Available

  • K2 Medical Research

    Maitland 4163220, Florida 4155751 32751
    United States

    Site Not Available

  • Atlanta Center of Medical Research

    Atlanta, Georgia 30331
    United States

    Site Not Available

  • CenExel iResearch, LLC (CenExel iRA)

    Decatur, Georgia 30030
    United States

    Site Not Available

  • Atlanta Center of Medical Research

    Atlanta 4180439, Georgia 4197000 30331
    United States

    Site Not Available

  • CenExel iResearch, LLC (CenExel iRA)

    Decatur 4191124, Georgia 4197000 30030
    United States

    Site Not Available

  • CenExel-HRI

    Marlton, New Jersey 08053
    United States

    Site Not Available

  • CenExel-HRI

    Marlton 4502911, New Jersey 5101760 08053
    United States

    Site Not Available

  • Duke Early Phase Research Unit

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Duke Early Phase Research Unit

    Durham 4464368, North Carolina 4482348 27710
    United States

    Site Not Available

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