Recruiting
Phase 1

VY1706

Sponsor:

Voyager Therapeutics

Code:

NCT07764146

Conditions

Alzheimer s Disease

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

Interventions

VY1706 Low dose

VY1706 Mid dose

VY1706 High Dose

Anti-AAV9 Total Antibody (TAb) Assay

Study Details

Brief summary:

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

Conditions

Alzheimer s Disease

Study ID

NCT07764146

Start date

Sep 3, 2026

Status verified date

Sep, 2026

Completion date

Apr 28, 2029

Anticipated

Primary completion date

Apr 28, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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..

Study Design

Enrollment

18 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Low dose IV Infusion

experimental: Mid dose IV Infusion

experimental: High dose IV Infusion

Interventions

VY1706 Low dose

Low dose

VY1706 Mid dose

Mid Dose

VY1706 High Dose

High dose

Anti-AAV9 Total Antibody (TAb) Assay

Anti-AAV9 Total Antibody (TAb) Assay

Primary 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 neurological exams and other safety measures [ Time Frame: 52 weeks ]

Central Contacts and Locations

Locations

K2 Medical Research, LLC

Recruiting

Maitland, Florida, United States, 32751

Contacts

Recruitment Coordinator

407-676-5252

More Information

Sponsor

Voyager Therapeutics

Last update posted

Sep 4, 2026

Last verified

Sep, 2026

Keywords

  • MCI due to AD
  • Mild AD

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Voyager Therapeutics on 2026-09-04.