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Not yet recruitingPhase 1

A Study of LY4560736 in Healthy Participants and Participants With Alzheimer's Disease (AD)

A Placebo-Controlled, Single- and Multiple-Ascending Dose, Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY4560736 in Healthy Participants and Participants With Alzheimer's Disease

Who can join

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

Age
18 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

  • Time periods mentioned: 13 weeks

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
  • "This part of the study lasts up to 13 weeks which includes staying in the Clinical Research Unit (CRU) for at least 4 days."
  • "For participants with Alzheimer's Disease, the study will also look at levels of a specific Alzheimer's-related protein in the brain and will last up to 13 weeks which includes staying in the CRU twice, each lasts about 1 to 2 days."
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 LY4560736 in healthy people and people with Alzheimer's disease. It checks how much and how quickly the drug enters the blood, and how much enters the brain in healthy people. For people with Alzheimer's, it also checks levels of a protein linked to the disease in the brain.

The purpose of this study is to see how safe LY4560736 is and to see how much and how quickly LY4560736 gets into the bloodstream. For healthy participants, the study also looks at how much LY4560736 gets into the brain. This part of the study lasts up to 13 weeks which includes staying in the Clinical Research Unit (CRU) for at least 4 days. This group will include Japanese participants, and the Sponsor may choose to enroll Chinese participants. For participants with Alzheimer's Disease, the study will also look at levels of a specific Alzheimer's-related protein in the brain and will last up to 13 weeks which includes staying in the CRU twice, each lasts about 1 to 2 days. Japanese participants, and potentially Chinese participants, may also be enrolled in this group.

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

Eligibility

Who can join

  • Must meet the rules in the A1D-MC-ATMP screening study before joining this treatment study.
  • To qualify as first-generation Japanese, you, your birth parents, and all four birth grandparents must be only of Japanese ancestry and born in Japan.
  • To qualify as Chinese, all four birth grandparents must be only of Chinese ancestry and born in China.

Who can't join

  • Have a condition that makes you more likely to get an infection.
  • Have an active infection now or have recently had a short-term, active infection.
  • Have active tuberculosis (TB), an infection, or have ever had inactive TB.
  • Are getting antibody medicines, which use immune system proteins to treat disease, or expect to start them during the study.

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

Official eligibility criteria

Inclusion Criteria: * Participants must meet eligibility criteria in the A1D-MC-ATMP screening protocol before entry into the treatment study. * To qualify as a participant of first-generation Japanese origin, the participant, the participant's biological parents, and all the participant's biological grandparents must be of exclusive Japanese descent and born in Japan. * To qualify as Chinese for this study, all four of the participant's biological grandparents must be of exclusive Chinese descent and born in China. Exclusion Criteria: * Have a condition that predisposes the participant to an infection. * Have a current or recent acute, active infection. * Have active tuberculosis (TB), have or have had latent TB. * Are receiving therapeutic antibodies or expected to initiate treatment with therapeutic antibodies during the study.

Study sites (13)

CA

FL

GA

  • Accel Research Sites - NeuroStudies Clinical Research Unit · Decatur, GA 30030 · Study contact · 404-475-0552Marshall Nash · Principal investigatorMore trials in Decatur

MI