Purpose

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

Condition

Eligibility

Eligible Ages
Between 30 Years and 80 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)
Masking Description
Open label multicenter dose escalation cohort study

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Low dose IV Infusion
  • Drug: VY1706 Low dose
    Low dose
  • Device: Anti-AAV9 Total Antibody (TAb) Assay
    Anti-AAV9 Total Antibody (TAb) Assay
Experimental
Mid dose IV Infusion
  • Drug: VY1706 Mid dose
    Mid Dose
  • Device: Anti-AAV9 Total Antibody (TAb) Assay
    Anti-AAV9 Total Antibody (TAb) Assay
Experimental
High dose IV Infusion
  • Drug: VY1706 High Dose
    High dose
  • Device: Anti-AAV9 Total Antibody (TAb) Assay
    Anti-AAV9 Total Antibody (TAb) Assay

Recruiting Locations

K2 Medical Research, LLC
Maitland, Florida 32751
Contact:
Recruitment Coordinator
407-676-5252

More Details

Status
Recruiting
Sponsor
Voyager Therapeutics

Study Contact

Voyager
857-259-5340
clinicaltrials@vygr.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.