68 Participants NeededMy employer runs this trial

LY4405094 for Alzheimer's Disease

Recruiting at 17 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Eli Lilly and Company

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called LY4405094 to assess its safety and how it moves through the body, targeting Alzheimer's disease. Researchers are also examining how LY4405094 affects a specific Alzheimer's-related protein in the brain. The trial includes two groups: healthy volunteers and those with Alzheimer's. Healthy individuals without allergies to the treatment or its components may qualify. Participants with a family history of adhesive skin allergies should not join. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Is there any evidence suggesting that LY4405094 is likely to be safe for humans?

Research has shown that LY4405094 is currently being tested for safety in humans. This is a Phase 1 study, marking the first time the treatment is tried in humans. This phase primarily assesses the treatment's safety and its effects on the body.

Specific information on how well people tolerate LY4405094 is not yet available, as testing is still in its early stages. However, Phase 1 trials are designed to closely monitor for any side effects. Researchers ensure participants' safety by closely observing them throughout the trial.

Although it's too early to determine the exact safety of LY4405094, this trial is a crucial step in understanding its effects on humans and may provide more detailed safety information in the future.12345

Why do researchers think this study treatment might be promising for Alzheimer's?

Researchers are excited about LY4405094 because it offers a fresh approach to tackling Alzheimer's disease. Unlike current treatments that primarily focus on managing symptoms, LY4405094 targets amyloid plaques in the brain, which are believed to play a central role in the disease's progression. This treatment is administered intravenously, potentially allowing for more precise dosing and quicker action. Additionally, the use of amyloid PET scans with tracers like Florbetapir F 18 or Florbetaben F 18 helps in tracking the effectiveness of the drug directly in the brain, providing a more tailored treatment experience.

What evidence suggests that LY4405094 might be an effective treatment for Alzheimer's Disease?

Research has shown that LY4405094 is under investigation for its potential to help with Alzheimer's disease by targeting specific proteins linked to the condition. Alzheimer's disease involves an unusual build-up of proteins in the brain, leading to memory loss and cognitive issues. LY4405094 aims to interact with these proteins to reduce their harmful effects. In this trial, participants will receive LY4405094 in either a single-ascending dose, multiple-ascending dose, or a placebo. Although human data on LY4405094's effectiveness for Alzheimer's is limited, the treatment is based on understanding these proteins' behavior in the brain. Early signs suggest it might help address the protein-related issues of Alzheimer's disease.678910

Who Is on the Research Team?

C1

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

This trial is for healthy adults and people diagnosed with Alzheimer's disease. Participants must be able to stay in a clinical research unit for several days, and those with Alzheimer's need a caregiver. People with certain medical conditions or who can't safely participate will not be included.

Inclusion Criteria

Participants must meet eligibility criteria in the ATMP screening protocol before entry into the treatment study.

Exclusion Criteria

Known allergic reactions to adhesive or hydrogels or a family history of adhesive skin allergies.
Known allergies to LY4405094, related compounds (including remternetug), or any components of the formulation, including LY4405094.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive LY4405094 or placebo. Healthy participants receive a single ascending dose, while participants with Alzheimer's Disease receive multiple ascending doses. Includes a stay in the Clinical Research Unit (CRU).

13 weeks for healthy participants, 25 weeks for participants with Alzheimer's Disease
4-day stay in CRU for healthy participants, 3-day stay in CRU for participants with Alzheimer's Disease

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of Alzheimer's-related protein levels in the brain for participants with Alzheimer's Disease.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • LY4405094

Trial Overview

The study is testing the safety of a new drug called LY4405094 compared to placebo. It also uses brain scans (Florbetapir F18 or Florbetaben F18) to measure Alzheimer’s-related proteins. The study looks at how the drug moves through the body in both healthy people and those with Alzheimer’s.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Placebo Group

Group I: LY4405094 Part B: Multiple Ascending Dose (MAD)Experimental Treatment3 Interventions
Group II: LY4405094 Part A: Single-Ascending Dose (SAD)Experimental Treatment1 Intervention
Group III: Placebo Part APlacebo Group1 Intervention
Group IV: Placebo Part BPlacebo Group3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials
2,708
Recruited
3,720,000+
Dr. Daniel Skovronsky profile image

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks profile image

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

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