NCT07764146 An Open Label Dose Escalation Study of VY1706 in Participants With Early Alzheimer's Disease

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.

This trial targets 18 participants in total. It began in 2026-09-03 with a primary completion date of 2029-04-28.

Brief Summary

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

Eligibility Criteria

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..

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