PMN310 for Alzheimer's Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the safety and effectiveness of PMN310, an experimental drug for individuals in the early stages of Alzheimer's disease. Participants will receive either PMN310 or a placebo through an IV infusion to observe the drug's effects on their condition. The trial seeks individuals with mild memory issues due to Alzheimer's who are not residing in a long-term care facility. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Will I have to stop taking my current medications?
The trial allows patients to continue taking FDA-approved acetylcholinesterase inhibitors or memantine as long as the dose has been stable for at least 3 months before screening. However, if you are currently receiving anti-amyloid treatments, you must stop them at least 9 months before screening.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that PMN310 is generally well-tolerated. In earlier studies, patients received monthly doses of PMN310, which reached effective levels in the body without causing major problems. Unlike some treatments that target amyloid plaque and raise safety concerns, PMN310 focuses on harmful proteins called toxic amyloid-beta oligomers, which are linked to Alzheimer's, to avoid these issues.
Animal studies have tested the treatment, and it successfully protected against the harmful effects of these proteins. While this is encouraging, these studies are still early steps in understanding PMN310's safety for humans. As this is a Phase 1 trial, the main goal is to learn more about its safety and how the body processes the treatment.12345Why do researchers think this study treatment might be promising for Alzheimer's?
Most treatments for Alzheimer's disease, like donepezil and memantine, focus on managing symptoms rather than targeting the underlying cause. PMN310 is unique because it targets toxic amyloid-beta oligomers, which are believed to play a key role in the progression of Alzheimer's. Researchers are excited because PMN310's specificity could potentially slow down or halt the disease process, offering more than just symptomatic relief. This approach could represent a significant advancement in treating Alzheimer's by addressing the root of the problem.
What evidence suggests that PMN310 might be an effective treatment for Alzheimer's?
Research has shown that PMN310 is a promising treatment for Alzheimer's disease. It targets the harmful forms of amyloid-beta, a protein linked to Alzheimer's, without affecting the harmless forms. This approach could reduce harmful effects while avoiding unnecessary interactions. Early studies showed positive results regarding the drug's safety and patient tolerance. The U.S. FDA has given PMN310 a Fast Track designation, recognizing its potential to meet the urgent need for better Alzheimer's treatments. These findings suggest that PMN310 could effectively treat Alzheimer's by focusing on the most harmful proteins involved in the disease. Participants in this trial will receive one of three dosages of PMN310 or a placebo, administered as a 60-minute infusion.36789
Are You a Good Fit for This Trial?
This trial is for individuals with early Alzheimer's disease. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and may be required to have a particular stage or severity of Alzheimer's.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive PMN310 or placebo once every 28 days for a total of 12 infusions
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- PMN310
Find a Clinic Near You
Who Is Running the Clinical Trial?
ProMis Neurosciences, Inc
Lead Sponsor