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VY7523

Phase 1

Alzheimer's Disease (AD) | Small molecule | Neurology |Voyager Therapeutics, Inc.|Last Updated: Nov 19, 2025

Success Probability
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Market & Valuation
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment52
FDA Designations
No designations recorded
Clinical trial landscape

VY7523 · 1 trial · 1 indication

Phase 1 1
NCT06874621VY7523-102: Randomized, Placebo-Controlled, Double-Blind, Multiple Ascending Dose Study in Participants With Early Alzheimer's DiseaseAlzheimer's Disease (AD)
ACTIVE NOT_RECRUITING52 Analytics
PHASE1ACTIVE NOT_RECRUITING
VY7523-102: Randomized, Placebo-Controlled, Double-Blind, Multiple Ascending Dose Study in Participants With Early Alzheimer's Disease
Alzheimer's Disease (AD)
NCT0687462152
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Study Endpoints
Primary Endpoints
Characterization of the safety and tolerability of VY7523 in participants with early AD
Cohorts 1 and 2: up to 6 months Cohort 3: up to 12 months

Incidence of treatment-emergent adverse events (TEAEs) and clinically significant changes from baseline

Secondary Endpoints
To characterize the pharmacokinetics (PK) of VY7523 in serum
Cohort 1 & 2: Month 1 - 6 Cohort 3: Month 1-7, 9, 12
To evaluate the ability of VY7523 to prevent the spread of pathologic tau; Cohort 3 only
Month 6, 12
To evaluate the immunogenicity of multiple, escalating intravenous (IV) doses of VY7523
Cohort 1 & 2: Month 1, 3, 4, 5 & 6 Cohort 3: Month 1, 2, 6, 9, 12
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cohort 1 activeEXPERIMENTALLow dose VY7523
Cohort 1 placeboPLACEBO_COMPARATORVY7523 matching placebo for Cohort 1 active dose
Cohort 2 activeEXPERIMENTALmid dose VY7523
Cohort 2 placeboPLACEBO_COMPARATORVY7523 matching placebo for Cohort 2 active dose
Cohort 3 activeEXPERIMENTALhigh dose VY7523
Cohort 3 placeboPLACEBO_COMPARATORVY7523 matching placebo for Cohort 3 active dose
Interventions
NameTypeDescription
VY7523DRUGVY7523 is a recombinant humanized immunoglobulin gamma 4 (IgG4) monoclonal antibody targeting human pathological tau
Placebo ComparatorDRUGMatching placebo to VY7523
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Eligibility Criteria
Age Range50 Years to 90 Years
SexALL
Healthy VolunteersNo
Study Sites23

Inclusion Criteria: 1. Clinical diagnosis of early AD, defined as: 1. Meet the NIA-AA core clinical criteria for MCI due to AD or mild AD. 2. Mini Mental State Examination (MMSE) score between 18 and 30, inclusive, at Screening (Cohort 1 and 2) and score between 22 and 30, inclusive, at Scre...

Countries:United StatesCanada
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Competitive Landscape -Alzheimer's Disease 66 trials (matched to "Alzheimer's Disease (AD)")

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AC Immune SAACIU2PHASE1ACI-24.060 at Dose A in Study Part 1a, ACI-24.060 at Dose B in Study Part 1a, ACI-24.060 at Dose C in Study Part 1a, ACI-24.060 with an additional adjuvant at Dose D in Study Part 1b, ACI-24.060 at Dose A in Study Part 2
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Voyager Therapeutics, Inc.VYGR1PHASE1VY7523
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06874621primaryCompletionDate: changed
LOWMay 24, 2026NCT06874621studyFirstPostDate: changed