Testing increasing doses of VY1706 in people with early Alzheimer's disease
Tests the safety of VY1706 at rising doses in early Alzheimer's disease.
Plain-language title generated from the registry record
Registry title: An Open Label Dose Escalation Study of VY1706 in Participants With Early Alzheimer's Disease
Key facts
- Where
- Maitland and Orlando, United StatesSee the 2 sites
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 30 and 80 years old?
Source: NCT07764146, who can take part
Where in United States
- K2 Medical Research, LLCMaitland, United StatesTaking people
- AdventHealth OrlandoOrlando, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Voyager Therapeutics
- Trial code
- NCT07764146
- Record updated
- 29 October 2026
- Original description
VY1706 first in human study in early Alzheimer's Disease is a multicenter dose escalation studyRead full original descriptionShow less
An Open Label Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of VY1706 in Participants With Early Alzheimer's Disease
VY1706 first in human study in early Alzheimer's Disease is a multicenter dose escalation study
Inclusion: 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: 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); Contraindications to lumbar puncture, MRI imaging, PET imaging or corticosteroids; History within 1 year prior to screening of drug or alcohol abuse; 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; 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; 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; History of, or positive test result for human immunodeficiency virus (HIV), hepatitis C or current acute hepatitis B; History of severe allergies, or history of an anaphylactic reaction (nonactive hay fever is acceptable).