NCT06356662招募中1 期
Efficacy and Safety of Tenofovir Disoproxil Fumarate in the Treatment of Parkinson's Disease
The Fourth Affiliated Hospital of Zhejiang University School of Medicine1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年1月23日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- UPDRS III（Unified Parkinson's Disease Rating Scale part 3）
研究概览
简要总结
To evaluate the efficacy and safety of tenofovir disoproxil fumarate in the treatment of Parkinson's disease. The changes of motor symptoms and the occurrence of adverse reactions in early Parkinson's disease patients who took tenofovir disoproxil fumarate and did not take Tenofovir disoproxil fumarate at different time points were compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1: Parkinson's disease: Hoehn Yahr= 1 to 2.5 2: MMSE score≥24
排除标准
- •1: essential tremor, stroke, epilepsy and other well-defined neurological disorders
- •2: Or have received deep brain stimulation and other brain surgery
- •3: Abnormal liver and kidney function
- •4: Infected with chronic hepatitis B or AIDS (HIV-1 infection)
- •5: Severe depression, schizophrenia, other psychiatric disorders or drug dependence
- •6: Other serious physical diseases such as heart, lung, liver, kidney disease, blood disease and malignant tumor
- •7: Pregnant or lactating women and seniors over 65 years of age
- •8: Allergy or other contraindications to the investigational drug
研究组 & 干预措施
Tenofovir
Experimental
patients with parkinson's disease
干预措施: Tenofovir Disoproxil Fumarate (Drug)
Placebo
Placebo Comparator
patients with parkinson's disease
干预措施: Tenofovir Disoproxil Fumarate (Drug)
结局指标
主要结局
UPDRS III（Unified Parkinson's Disease Rating Scale part 3）
时间窗: 1 month、3 month
score：0-132，higher scores mean a worse outcome
次要结局
- creatinine(μmoI/L)(1 month、3 month)
- Non-Motor Symptom Scale（NMSS）(1 month、3 month)
研究者
研究点 (1)
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