VY7523 for Alzheimer's Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test the safety and effectiveness of a new drug, VY7523, for treating early Alzheimer's disease. Researchers are examining how the drug works in the brain and comparing it to a placebo (a non-active treatment) across three different dose levels. Individuals with early Alzheimer's who have noticed a gradual memory decline over the past six months and are in good overall health might be a good fit for this study. Participants will be monitored for 6 to 12 months, depending on the dose they receive. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.
Will I have to stop taking my current medications?
If you're on an approved Alzheimer's medication, you need to be on a stable dose for at least 8 weeks before joining the study. For other medications, you should be on a stable dose for at least 4 weeks. You cannot participate if you're currently on any anti-amyloid therapies.
Is there any evidence suggesting that VY7523 is likely to be safe for humans?
A previous study tested VY7523 on healthy volunteers and found it to be safe and well-tolerated. No serious or severe side effects occurred, which is promising. The study showed that the drug behaved predictably in the body, being absorbed and processed as researchers expected. This provides some confidence in its safety before testing it in people with early Alzheimer's Disease. Although the drug has not yet received approval for any condition, these early results are encouraging for those considering joining the trial.12345
Why do researchers think this study treatment might be promising for Alzheimer's?
Researchers are excited about VY7523 because it offers a fresh approach to tackling Alzheimer's Disease. Unlike standard treatments like donepezil or memantine, which mainly focus on managing symptoms, VY7523 is designed to target the underlying disease process more directly. It works through a novel mechanism that may influence disease progression, potentially slowing down or altering the course of Alzheimer's. This innovative approach could provide significant benefits over existing therapies, which primarily offer symptomatic relief.
What evidence suggests that VY7523 might be an effective treatment for Alzheimer's Disease?
Research shows that VY7523 is a medicine designed to target tau proteins in the brain, which are linked to Alzheimer's disease. These proteins contribute to the progression of Alzheimer's, making them crucial to address in treatment. Early studies suggest that VY7523 is safe and well-tolerated in healthy individuals, with no serious side effects reported. The drug's behavior in the body changes predictably with varying doses. Although it's still early, these findings offer hope that VY7523 could help slow or treat Alzheimer's by focusing on tau proteins.12356
Who Is on the Research Team?
Chief Medical Officer
Principal Investigator
Voyager Therapuetics, Inc.
Are You a Good Fit for This Trial?
This trial is for individuals with early Alzheimer's Disease. Participants should have a diagnosis of Alzheimer's and be in the initial stages of the disease. They must have previously tolerated similar studies well, if applicable.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive multiple ascending intravenous doses of VY7523 or placebo, with dose escalation based on safety reviews
Follow-up
Participants are monitored for safety and effectiveness after treatment
Extension
Participants in Cohort 3 are monitored for long-term effects and efficacy of the high dose
What Are the Treatments Tested in This Trial?
Interventions
- VY7523
Find a Clinic Near You
Who Is Running the Clinical Trial?
Voyager Therapeutics
Lead Sponsor