MedTrace Logo

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

NCT06874621 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2025-11-19

No results posted yet for this study

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

DRUG

VY7523

VY7523 is a recombinant humanized immunoglobulin gamma 4 (IgG4) monoclonal antibody targeting human pathological tau

DRUG

Placebo Comparator

Matching placebo to VY7523

Sponsors & Collaborators

  • Voyager Therapeutics

    lead INDUSTRY

Principal Investigators

  • Chief Medical Officer · Voyager Therapuetics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
50 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-03
Primary Completion
2027-05-31
Completion
2027-05-31
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06874621 on ClinicalTrials.gov