179 Participants NeededMy employer runs this trial

Amyloid-Targeting Therapies for Alzheimer's Disease

Recruiting at 18 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Eli Lilly and Company
Must be taking: Cholinesterase inhibitors, Memantine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, LY4405094, to determine if it can safely remove protein clumps in the brain linked to Alzheimer's disease. The trial includes two groups: healthy individuals and those with Alzheimer's. Healthy participants must not have any serious health issues, while those with Alzheimer's should have experienced memory changes for at least six months and need a reliable study partner. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Do I need to stop taking my current medications for the trial?

If you are taking medications for Alzheimer's disease, like cholinesterase inhibitors or memantine, you need to have been on a stable dose for at least 8 weeks before joining the study, and you should continue on that stable dose during the trial. The protocol does not specify requirements for other medications.

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

Research shows that LY4405094 remains in the early testing phase. Since this trial is in Phase 1, the main goal is to determine the drug's safety and how well participants tolerate it. Researchers closely monitor for any side effects or unexpected reactions.

LY4405094 targets amyloid plaques, which are protein clumps that accumulate in the brains of people with Alzheimer's disease. Although specific data from previous human studies on LY4405094 is not yet available, other drugs targeting amyloid have been tested. These studies sometimes report side effects, often mild. Common side effects in similar treatments include headache, nausea, or minor reactions at the injection site.

Without clear data, it is important to remember that early-phase trials are crucial for understanding safety. Researchers closely monitor participants to ensure their well-being.12345

Why are researchers excited about this trial?

Most treatments for Alzheimer's disease focus on managing symptoms rather than targeting the underlying causes. But LY4405094 is different, as it specifically targets amyloid plaques, which are thought to play a key role in the progression of Alzheimer's. This drug is administered either intravenously or subcutaneously, offering flexibility in delivery methods. Researchers are excited about LY4405094 because it could potentially alter the disease course by directly addressing the amyloid buildup, offering hope for more effective long-term management of Alzheimer's disease.

What evidence suggests that this trial's treatments could be effective for Alzheimer's disease?

Research has shown that LY4405094 targets amyloid plaques, clumps of protein in the brain linked to Alzheimer's disease. These plaques likely disrupt communication between brain cells, causing memory loss and thinking problems. Early findings suggest that removing these plaques might slow Alzheimer's progression. Some studies have found that treatments targeting amyloid can reduce plaque levels in the brain. In this trial, participants will receive either LY4405094 or a placebo to further investigate its effects. Although researchers are still studying LY4405094, its approach aligns with other promising strategies for addressing the root causes of Alzheimer's.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 people and those diagnosed with Alzheimer's disease. Participants must meet specific health requirements, but detailed criteria are not provided here.

Inclusion Criteria

Participants with AD have Mini-Mental State Exam (MMSE) score ≥16
Healthy Participants have a body mass index (BMI) of 18.0 to 32.0 kilograms per square meter (kg/m²)
Participants with AD have positive amyloid positron emission tomography (PET)
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Exclusion Criteria

All Participants have currently or history of serious or unstable neurological or psychological disease (except AD for AD cohorts)
All Participants have currently or history of allergies to monoclonal antibodies, diphenhydramine, epinephrine, or methylprednisolone
All Participants have currently or history of clinically significant multiple or severe drug allergies or severe posttreatment hypersensitivity reactions
See 12 more

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 administered intravenously (IV) or subcutaneously (SC) in healthy volunteers and participants with Alzheimer's disease. Florbetapir F 18 or Florbetaben F 18 will be administered IV during amyloid PET scan.

8-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • LY4405094

Trial Overview

The study tests several drugs that target amyloid plaques in the brain, including LY4405094 and imaging agents Florbetaben F18 and Florbetapir F18, compared to a placebo. The goal is to see if these treatments are safe and can reduce amyloid buildup.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: LY4405094 Study AT01 (Healthy ISA)Experimental Treatment2 Interventions
Group II: LY4405094 Study AT01 (AD ISA)Experimental Treatment4 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

Citations

What is Alzheimer's Disease? Symptoms & Causes | alz.org

Alzheimer's disease is a type of dementia that affects memory, thinking and behavior. Symptoms eventually grow severe enough to interfere with daily tasks.

What Is Alzheimer's Disease? | National Institute on Aging

Alzheimer's disease is the most common form of dementia, a brain disorder that slowly destroys a person's memory and thinking skills. It is ...

Alzheimer's disease - Symptoms and causes

Understand more about this brain disease that is the most common cause of dementia. Also learn about new tests and medicines.

About Alzheimer's | Alzheimer's Disease and Dementia

Alzheimer's disease is the most common type of dementia. Early symptoms typically appear after age 60, and the risk increases with age.

5.

alzfdn.org

alzfdn.org/

Alzheimer's Disease: Welcome to the Alzheimer's Foundation ...

Support, services & education for individuals, families & caregivers affected by Alzheimer's disease & related dementias. Research for treatment and a cure.

Alzheimer's Disease Facts and Figures

This report discusses the public health impact of Alzheimer's disease (AD), including incidence and prevalence, mortality rates, costs of care and the overall ...

Trial | NCT05771428

This study will assess how safe and effective ABBV-552 is in treating symptoms of early AD. Adverse events, change in disease activity, how ABBV-552 moves

Alzheimer's disease pipeline takes multiple hits

The majority of drugs in development for AD target amyloid-beta (Aß) aggregation into neurotoxic amyloid plaques in the brain. Despite many ...

10.

alzforum.org

alzforum.org/node

NETWORKING FOR A CURE

In March 2024, a Phase 2 study began testing daridorexant for insomnia in people with mild cognitive impairment or mild to moderate Alzheimer's ...