NCT06874621

VY7523-102: Randomized, Placebo-Controlled, Double-Blind, Multiple Ascending Dose Study in Participants With Early Alzheimer's Disease

VY7523-102: A Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Multiple Ascending Intravenous Doses of VY7523 in Participants With Early Alzheimer's Disease

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: Voyager Therapeutics · Industry
• Sex: All
• Age: 50 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

This study is to be conducted in participants with early Alzheimer's Disease to test VY7523, a new drug being researched for treatment of Alzheimer's Disease. This study will look at how safe the drug is and how it works in the brain. It was first tested in normal, healthy participants who volunteered to participate. The study will look at three different dose levels, starting with the lowest dose first and moving to higher doses and more participants after safety has been reviewed by doctors and researchers. Some patients will receive drug while others will receive placebo. This will help to better compare how the drug works between participants receiving drug and placebo. The study will last up to 6 months for the lower dose groups and 12 months for the highest dose group.

Conditions

• Alzheimer's Disease (AD)

Interventions

Type	Name	Description
DRUG	VY7523	VY7523 is a recombinant humanized immunoglobulin gamma 4 (IgG4) monoclonal antibody targeting human pathological tau
DRUG	Placebo Comparator	Matching placebo to VY7523

Timeline

• Start date: 2025-03-03
• Primary completion: 2027-05-01
• Completion: 2027-05-01
• First posted: 2025-03-13
• Last updated: 2025-11-19

Locations

23 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study