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RecruitingPhase 1

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
45 Years to 85 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Blood tests will be performed to check how much LY4006895 gets into the bloodstream and how long it takes the body to eliminate it."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety of LY4006895 and how well people can handle it. Part A gives one dose to healthy people, and Part B gives repeated doses to people with early Alzheimer's disease symptoms. Blood tests measure how much drug enters the blood and how long it stays in the body.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Both parts: Have a body mass index (BMI), a measure of weight compared with height, from 18 to 40.
  • Part A: Be healthy based on a medical check. You cannot repeat screening.
  • Part B: Have early Alzheimer's disease symptoms, with memory getting worse slowly for at least 6 months.
  • Part B: Score 18 to 30 on the Mini-Mental State Exam, a memory and thinking test.
  • Part B: Have a Clinical Dementia Rating of 0.5 to 1.0, with a memory score of at least 0.5. This test rates memory and daily skills.
  • Part B: Have up to 2 reliable study partners with at least 10 hours of contact each week. One must come to visits, be available for scheduled phone calls, and give written consent.

Who can't join

  • Both parts: Have a serious or unstable illness that could prevent finishing the study, or be expected to live less than 24 months.
  • Both parts: Have hemoglobin below 12 g/dL, ferritin below 30 ng/mL, or a current or past hemoglobin disorder. Hemoglobin carries oxygen in blood; ferritin measures stored iron.
  • Both parts: Be at serious risk of suicide, based on the study doctor's judgment.
  • Both parts: Regularly misuse drugs, or have a positive urine drug test not explained by your regular medicines.
  • Both parts: Have ever received treatment targeting tau, a protein linked to Alzheimer's. Part B also excludes current treatment targeting amyloid, another protein linked to Alzheimer's. Treatment stopped over 1 year ago may be allowed with study doctor and sponsor review.
  • Both parts: Be pregnant, plan to become pregnant, or plan to breastfeed during the study.
  • Part B: Be sensitive to florataucipir 18F.
  • Part B: Be unable to have an MRI scan, including because of fear of enclosed spaces or certain metal implants or heart pacemakers.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (11)

CA

FL

GA

MI

NC

NJ