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

NCT07764146 | Recruiting Phase 1 DMC FDA Drug FDA Device

• 1 other identifier: VY1706-101
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Alzheimer s Disease

Keywords

MCI due to AD; Mild AD

Outcome Measures

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

  52 weeks

Secondary Outcomes (2)

• To evaluate the effect of VY1706 on CSF biomarkers of Tau

  52 weeks

• To evaluate the effect of VY1706 on Tau pathology

  52 weeks

Study Arms (3)

Low dose IV Infusion

EXPERIMENTAL

Drug: VY1706 Low dose; Device: Anti-AAV9 Total Antibody (TAb) Assay

Mid dose IV Infusion

EXPERIMENTAL

Drug: VY1706 Mid dose; Device: Anti-AAV9 Total Antibody (TAb) Assay

High dose IV Infusion

EXPERIMENTAL

Drug: VY1706 High Dose; Device: Anti-AAV9 Total Antibody (TAb) Assay

Interventions

VY1706 Low dose DRUG

Low dose

Low dose IV Infusion

VY1706 Mid dose DRUG

Mid Dose

Mid dose IV Infusion

VY1706 High Dose DRUG

High dose

High dose IV Infusion

Anti-AAV9 Total Antibody (TAb) Assay DEVICE

Anti-AAV9 Total Antibody (TAb) Assay

High dose IV Infusion; Low dose IV Infusion; Mid dose IV Infusion

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Evidence of amyloid and tau pathology consistent with AD diagnosis by both:
• 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.
• Stable doses of all other (non-AD-related) concomitant medications for at least 4 weeks prior to Screening and until Day 1.
• Must have an identified reliable Study Partner.

You may not qualify if:

• Any medical or neurological/neurodegenerative or psychiatric condition (other than AD) that may be a contributing cause to cognitive impairment or could confound interpretation of drug effect, affect study assessments, or affect participant's ability to participate and complete the study or lead to safety concerns.
• 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.
• History of significant cardiovascular disease.
• Contraindications to lumbar puncture, MRI imaging, PET imaging or corticosteroids.
• History of, or positive test result for human immunodeficiency virus (HIV), hepatitis C or current acute hepatitis B.
• History within 1 year prior to screening of drug or alcohol abuse.
• History of severe allergies, or history of an anaphylactic reaction (nonactive hay fever is acceptable).
• Previous or current use of an approved AD disease-modifying therapies
• Previous or current participation in a clinical study involving any cell or gene therapies (including but not limited to AAV-based gene therapies) or active immunotherapies targeting Tau or amyloid, or any anti-amyloid or anti-Tau therapies or any therapeutic mAb, protein derived from a mAb, immunoglobulin therapy, antisense oligonucleotides, small interfering ribonucleic acid, or any other agent with purported disease-modifying effect in AD unless it can be documented that the participant only received placebo..

Sponsors & Collaborators

• Voyager Therapeutics: lead

Study Sites (1)

K2 Medical Research, LLC

Maitland, Florida, 32751, United States

RECRUITING

MeSH Terms

Interventions

Biological Assay

Intervention Hierarchy (Ancestors)

Investigative Techniques

Central Study Contacts

Voyager

CONTACT

857-259-5340; clinicaltrials@vygr.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Open label multicenter dose escalation cohort study
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2026
• First Posted: August 13, 2026
• Study Start: September 3, 2026
• Primary Completion (Estimated): April 28, 2029
• Study Completion (Estimated): April 28, 2029
• Last Updated: September 4, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)