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

RecruitingPhase 1Ages 30 Years - 80 YearsAllVoyager Therapeutics
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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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What it tests

  • VY1706 Low dose
  • VY1706 Mid dose
  • VY1706 High Dose
  • Anti-AAV9 Total Antibody (TAb) Assay
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Where

2 sites
K2 Medical Research, LLC
Maitland, United States
AdventHealth Orlando
Orlando, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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