Simufilam for Alzheimer's Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests simufilam, a new treatment for individuals with mild-to-moderate Alzheimer's disease. The goal is to determine the long-term safety of simufilam and monitor any side effects. Participants must have completed a previous study with this medication to join. This trial is crucial for understanding simufilam's effects over an extended period. As a Phase 2 trial, it measures the treatment's effectiveness in an initial, smaller group.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that simufilam is likely to be safe for humans?
Research has shown that simufilam is well-tolerated by people with mild-to-moderate Alzheimer's disease. One study found that simufilam maintained a good safety record. An independent board reviewed the safety data and recommended that the ongoing trials continue without changes. This suggests that simufilam is generally safe for participants. However, while simufilam has a good safety record, it did not achieve key goals for improving memory or daily functioning in some trials. This indicates that while the treatment seems safe, its effectiveness in treating Alzheimer's symptoms is still under investigation.12345
Why do researchers think this study treatment might be promising for Alzheimer's?
Unlike the standard treatments for Alzheimer's disease, which often focus on managing symptoms, simufilam is unique because it targets an underlying biological process. Specifically, simufilam works by stabilizing a protein called filamin A, which researchers believe plays a key role in the dysfunction of neurons in Alzheimer's. This novel approach could potentially slow or even halt the progression of the disease, offering hope beyond the typical symptom relief provided by current medications like donepezil or memantine. Researchers are excited about simufilam because it represents a promising shift towards addressing the root causes of Alzheimer's, rather than just its symptoms.
What evidence suggests that simufilam might be an effective treatment for Alzheimer's?
Research shows that simufilam, which participants in this trial will receive, might help slow memory and thinking problems in people with mild-to-moderate Alzheimer's disease. One study found that people taking simufilam experienced a 38% slower decline in memory and thinking skills over six months compared to those not taking the drug. However, another study did not find significant improvements in memory or daily activities. Despite these mixed results, ongoing trials have found simufilam to be safe, with no major safety concerns. While its effectiveness is still under study, simufilam could potentially help some patients.23467
Who Is on the Research Team?
Chris Cook, JD
Principal Investigator
Chief Operating and Legal Officer
Are You a Good Fit for This Trial?
This clinical trial is open to individuals with mild-to-moderate Alzheimer's Disease who have completed the PTI-125-04 study. It's designed to assess long-term treatment effects and safety over a period of 96 weeks.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Open-label Extension
Participants receive simufilam 100 mg b.i.d. for long-term treatment and safety evaluation
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- simufilam
Find a Clinic Near You
Who Is Running the Clinical Trial?
Cassava Sciences, Inc.
Lead Sponsor