Amyloid-Targeting Therapies for Alzheimer's Disease
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.12345Why 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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
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.
Follow-up
Participants are monitored for safety and effectiveness after treatment
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
LY4405094 or placebo administered intravenously (IV) or subcutaneously (SC) in healthy volunteers.
LY4405094 or placebo administered IV to participants with AD. Florbetapir F 18 or Florbetaben F 18 will be administered IV during amyloid positron emission tomography (PET) scan.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Eli Lilly and Company
Lead Sponsor
Dr. Daniel Skovronsky
Eli Lilly and Company
Chief Medical Officer since 2018
MD from Harvard Medical School
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.
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.
Publications
Discover and download Alzheimer's Disease data, analyses, and tools from the National Institute on Aging's Alzheimer's Disease Translational Research ...
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 ...
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 ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.