LPS for Alzheimer's Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to understand how microglia (immune cells in the brain) react in people with Alzheimer's Disease compared to those without it. Participants will receive lipopolysaccharide, a compound used to activate immune cells, to stimulate these brain cells, and researchers will observe the differences. This trial suits individuals diagnosed with mild Alzheimer's Disease who have a caregiver and can consent to participate.
As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to contribute to groundbreaking insights into Alzheimer's Disease.
Will I have to stop taking my current medications?
The trial requires that you stop using over-the-counter medications that may affect the immune system, like ibuprofen, and corticosteroids or immunosuppressant drugs at least 3 weeks before the PET scan. Investigational agents are also prohibited 4 weeks prior to entry and during the study.
Is there any evidence suggesting that lipopolysaccharide is likely to be safe for humans?
Research has shown that lipopolysaccharide (LPS) is generally safe and well-tolerated for studying inflammation in people. A review of 155 studies found that negative side effects were rare, indicating the LPS model's reliability for research. However, LPS triggers a strong inflammatory response, which is why researchers use it in these studies. The dose in this trial is lower than the highest safe dose of 4 ng/kg administered intravenously, ensuring safety for participants.12345
Why do researchers think this study treatment might be promising?
Researchers are excited about this trial because it explores a novel way to understand microglia function in Alzheimer's disease using PBR28 brain PET imaging combined with a lipopolysaccharide (LPS) challenge. Unlike standard Alzheimer's treatments, which typically focus on reducing amyloid plaques or tau tangles, this approach targets the role of microglia, the brain's immune cells, potentially offering new insights into the disease's progression. By using LPS, a component that triggers an immune response, researchers hope to better visualize and understand how microglia activity correlates with Alzheimer's, paving the way for innovative therapeutic strategies.
What evidence suggests that lipopolysaccharide might be an effective treatment for Alzheimer's Disease?
Research shows that a substance called lipopolysaccharide (LPS) can cause inflammation in the body. Animal studies have found that LPS affects memory, particularly the ability to remember locations. It also influences the behavior of certain human cells and gene expression. These effects relate to its role in triggering immune responses, providing insight into its potential impact on brain function. In this trial, participants will receive LPS to study its effects. Although no direct proof exists yet that LPS can treat Alzheimer's, its ability to activate immune cells might offer insights into the disease.678910
Who Is on the Research Team?
Adam Mecca, M.D., Ph.D.
Principal Investigator
Yale University
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive LPS (0.4 ng/kg) administered intravenously and undergo PET scanning
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Lipopolysaccharide
Find a Clinic Near You
Who Is Running the Clinical Trial?
Yale University
Lead Sponsor
National Institute on Aging (NIA)
Collaborator