NCT07764146招募中1 期
An Open Label Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of VY1706 in Participants With Early Alzheimer's Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
VY1706 first in human study in early Alzheimer's Disease is a multicenter dose escalation study
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Open label multicenter dose escalation cohort study
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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-
- •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
- •Stable doses of all other (non-AD-related) concomitant medications for at least 4 weeks prior to Screening and until Day
- •Must have an identified reliable Study Partner.
排除标准
- •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..
研究组 & 干预措施
Low dose IV Infusion
Experimental
干预措施: VY1706 Low dose (Drug)
Low dose IV Infusion
Experimental
干预措施: Anti-AAV9 Total Antibody (TAb) Assay (Device)
Mid dose IV Infusion
Experimental
干预措施: VY1706 Mid dose (Drug)
Mid dose IV Infusion
Experimental
干预措施: Anti-AAV9 Total Antibody (TAb) Assay (Device)
High dose IV Infusion
Experimental
干预措施: VY1706 High Dose (Drug)
High dose IV Infusion
Experimental
干预措施: Anti-AAV9 Total Antibody (TAb) Assay (Device)
结局指标
主要结局
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
时间窗: 52 weeks
Incidence of treatment emergent adverse events, clinically significant changes from baseline in vital signs, physical and neurological exams, Columbia Suicide-Severity Rating Scale, Electrocardiogram, Clinical lab parameters and transthoracic echocardiogram
次要结局
- To evaluate the effect of VY1706 on CSF biomarkers of Tau(52 weeks)
- To evaluate the effect of VY1706 on Tau pathology(52 weeks)
研究者
研究点 (1)
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