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

ConditionAlzheimer s Disease
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age30-80
SponsorVoyager Therapeutics

About this trial

VY1706 first in human study in early Alzheimer's Disease is a multicenter dose escalation study

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female participants aged 55 to 80 years (inclusive) at Screening or aged 30 to 80 years (inclusive) if presence of a historically documented dominantly inherited mutation associated with monogenic AD.

Clinical diagnosis of mild cognitive impairment (MCI) due to AD or mild AD with MMSE 18-30 and CDR Global score of 0.5-1.

Apart from the clinical diagnosis of early AD, participant must be in good health as determined by the Investigator.

If the participant is receiving an approved symptomatic AD treatment, such as acetylcholinesterase or NMDA inhibitors, the participant must be on a stable dose for at least 8 weeks prior to Screening and until Day 1.

Disqualifiers

Seropositive for anti-AAV9 antibodies at Screening.

History of transient ischemic attack or stroke or any unexplained loss of consciousness within 1 year prior to Screening.

History of seizures within 10 years prior to Screening or history of epileptic syndrome (except for history of febrile seizures in childhood).

Presence of a clinically significant uncontrolled medical disorder that may compromise the participant's safety or their ability to complete all of the study assessments.

Trial design

Design model

Sequential

Treatments tested in this trial

  • VY1706 Low dose

    Drug

    Low dose

  • VY1706 Mid dose

    Drug

    Mid Dose

  • VY1706 High Dose

    Drug

    High dose

  • Anti-AAV9 Total Antibody (TAb) Assay

    Device

    Anti-AAV9 Total Antibody (TAb) Assay

Treatment groups

18 Participants
are divided into 3 treatment groups
Group A: Low dose IV InfusionExperimental treatment 2 interventions
Group B: Mid dose IV InfusionExperimental treatment 2 interventions
Group C: High dose IV InfusionExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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

Incidence of treatment emergent adverse events, clinically significant changes from baseline in vital signs, physical and neurological exams, Columbia Suicide-Severity Rating Scale, Electrocardiogram, Clinical lab parameters and transthoracic echocardiogram

Time frame
52 weeks

Secondary outcomes

1

To evaluate the effect of VY1706 on CSF biomarkers of Tau

Change in baseline in CSF biomarkers of Tau

Time frame
52 weeks
2

To evaluate the effect of VY1706 on Tau pathology

Change from baseline in the SUVR on Tau pathology

Time frame
52 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Voyager Therapeutics

Lead sponsor

Source ClinicalTrials.gov
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