NCT07566429尚未招募2 期
A Phase 2, Open-label, Single Group, Fixed-dose Study to Evaluate the Safety and Efficacy of a Single Bilateral Intraputaminal Administration of AB-1005 (AAV2-GDNF Gene Therapy) in Japanese Participants With Moderate Stage Parkinson's Disease
Bayer7 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2027年1月25日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 8
- 试验地点
- 7
研究概览
简要总结
The objective of this Phase 2, open-label, single group, one-time, fixed-dose study is to assess the safety and efficacy of bilateral intraputaminal infusion of AB-1005 (AAV2-GDNF gene therapy) in Japanese patients with moderate Parkinson's Disease (PD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female adults 45-75 years of age inclusive, at the time of signing of informed consent
- •Diagnosed with Parkinson's disease in the past 4-10 years (inclusive) and currently meeting all the following criteria:
- •Presence of bradykinesia PLUS any of the following: rigidity, rest tremor, postural instability
- •Presence of motor fluctuations as measured by the PD Motor Diary
- •Stable anti-parkinsonian medication regimen for 4 weeks or more, prior to screening
- •Responsiveness to levodopa therapy
排除标准
- •Known history or current evidence of medical, genetic, or neurological conditions that may provide an alternative to idiopathic PD diagnosis
- •Presence or history of significant vascular and/or cardiovascular disease
- •Presence of clinically significant cognitive impairment
- •Presence or history of psychosis or impulse control disorder
- •History of malignancy other than treated cutaneous squamous or basal cell carcinomas
- •Presence of clinically relevant conditions that could compromise surgical suitability and/or subject safety
- •Contraindication to magnetic resonance imaging and/or use gadolinium-based contrast agents
- •Prior history of brain surgery including, but no limited: DBS, pallidotomy focused ultrasound thalamotomy, or other experimental neurosurgical procedure
- •Chronic immunosuppressive therapy
研究组 & 干预措施
AB-1005 infusion
Experimental
干预措施: AB-1005 (Drug)
研究者
研究点 (7)
Loading locations...
相似试验
招募中
1 期
Study of CM383 in Healthy SubjectsNCT07292688Keymed Biosciences Co.Ltd30
尚未招募
1 期
68Ga-PSMA-0057 and 177Lu-PSMA-0057 in Patients With PSMA-Positive Metastatic Castration-Resistant Prostate CancerNCT07310355Chengdu StarRay Therapeutics Co., Ltd49
尚未招募
不适用
Safety and Preliminary Efficacy of Hibernation-Like Therapy (Chlorpromazine and Promethazine) in Patients With Acute Ischemic Stroke (AIS) Eligible for Reperfusion Therapy.NCT07364344Ji Xunming,MD,PhD57
尚未招募
1 期
BCMA-CD19 cCAR T for the Treatment of Refractory Inflammatory Bowel Disease (IBD)Inflammatory Bowel Diseases (IBD)NCT07544160iCell Gene Therapeutics18
招募中
2 期
MDMA Therapy in Veterans With PTSDPost Traumatic Stress DisorderNCT07569159Sunstone Medical52