VY1706 High Dose / Alzheimer S Disease / VY1706 Mid dose · Phase 1 Trial

An Open Label Dose Escalation Study of VY1706 in Participants With Early Alzheimer's Disease

ClinicalTrials.gov · August 13, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a registered but not-yet-recruiting Phase 1 first-in-human study of VY1706, a gene therapy candidate, in early Alzheimer's disease. The study aims to establish safety and tolerability across three dose levels over 52 weeks. No efficacy data or results are available from this registry record.

What was studied

Phase 1, Interventional, Non Randomized, Sequential, Open label, Treatment purpose. Alzheimer s Disease; age from 30 Years; to 80 Years. Intervention: Low dose IV Infusion; Mid dose IV Infusion; High dose IV Infusion. n = 18. Multicenter (specific sites not detailed in registry record).

Key findings

Safety

Open-label design without control arm limits interpretability of safety signals.

Who this may help

This registry entry documents a planned early-stage investigation and carries no clinical implications until results are available. Clinicians should await peer-reviewed efficacy and safety data before considering VY1706 for therapeutic use.

Plain-language summary

This is a Phase 1, open-label dose escalation study in early recruitment that has not yet posted results; it represents first-in-human work designed to characterize safety and tolerability.

Study design

As stated by the source record.

MethodsPrimary outcome measure: To characterize the safety and tolerability in participants with AD by Incidence of treatment emergent adverse events, changes from baseline in vital signs, physical and neurologi… (assessed at 52 weeks)

DesignPhase 1, Interventional, Non Randomized, Sequential, Open label, Treatment purpose

PopulationAlzheimer s Disease; age from 30 Years; to 80 Years

Sample size18

InterventionLow dose IV Infusion; Mid dose IV Infusion; High dose IV Infusion

SettingMulticenter (specific sites not detailed in registry record)

Reported figures

Quoted from the source exactly as published.

Planned sample size18

Study phasePhase 1

Primary outcome duration52 weeks

Study designOpen-label dose escalation

Primary outcome measureIncidence of treatment emergent adverse events, changes from baseline in vital signs, physical and neurological exams

Clinical bottom line

Caveats

This is a registry record; no results are posted or available.
Open-label design without control arm limits interpretability of safety signals.
First-in-human study; generalizability and clinical relevance unknown.
Recruitment has not yet started; enrollment and timeline are estimated only.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

limited

Open-label, uncontrolled dose escalation design; no comparator arm.

Directness

moderate

Early AD population; primary endpoints are safety and tolerability, not efficacy.

Consistency

insufficient

First-in-human study; no prior human data to evaluate consistency.

Risk of bias

limited

Open-label design with no blinding; recruitment not yet started.

Sample adequacy

limited

18 participants estimated across dose groups in Phase 1 escalation.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07764146). This is a study registration, not published results. Lead sponsor: Voyager Therapeutics. Recruitment status: NOT_YET_RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 18 participants (ESTIMATED). Conditions: Alzheimer s Disease. Interventions: DRUG: VY1706 Low dose; DRUG: VY1706 Mid dose; DRUG: VY1706 High Dose; DEVICE: Anti-AAV9 Total Antibody (TAb) Assay. Primary outcome measures: To characterize the safety and tolerability in participants with AD by Incidence of treatment emergent adverse events, changes from baseline in vital signs, physical and neurological exams and other safety measures , 52 weeks. Brief summary: VY1706 first in human study in early Alzheimer's Disease is a multicenter dose escalation study

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

VY1706 High DoseAlzheimer S DiseaseVY1706 Mid doseAnti-AAV9 Total Antibody (TAb) AssayVY1706 Low doseNCT07764146Voyager Therapeutics