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Phase 1Recruiting

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

Sponsored by Eli Lilly and Company

About this study

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.

Where this study is enrolling (11)

  • Collaborative Neuroscience Network - CNS

    Los Alamitos, California

    Call 8667874257 or 5627427116

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  • K2 Medical Research - The Villages

    Lady Lake, Florida

    Call 321-278-5590

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  • K2 Medical Research - Tampa

    Tampa, Florida

    Call 813-800-5252

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  • K2 Medical Research

    Maitland, Florida

    Call 407-500-5252

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  • Aqualane Clinical Research

    Naples, Florida

    Call 239-529-6780

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Show all 11 locations

  • Progressive Medical Research

    Port Orange, Florida

    Call 386-304-7070

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  • CenExel iResearch, LLC (CenExel iRA)

    Decatur, Georgia

    Call 404-537-1281

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  • Atlanta Center of Medical Research

    Atlanta, Georgia

    I'm interested

  • QUEST Research Institute

    Farmington Hills, Michigan

    Call 248-957-8940

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  • CenExel-HRI

    Marlton, New Jersey

    Call 856-452-9901

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  • Duke Early Phase Research Unit

    Durham, North Carolina

    Call 919-684-5196

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Who can participate

Inclusion criteria

  • ✓for Part A and Part B:
  • ✓\- Have a body mass index (BMI) within the range 18 to 40 kilogram per square meter (kg/m²)
  • ✓For Part A:
  • ✓Are overtly healthy as determined by medical evaluation. Rescreening is not allowed in this study
  • ✓For Part B:
  • ✓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
  • ✓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 pacemaker

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.