Clinical Study to Evaluate the Possible Efficacy of Metformin in Patients With Parkinson's Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- • The primary endpoint is the change in The Unified Parkinson's Disease Rating Scale (UPDRS)
研究概览
简要总结
Parkinson's disease (PD) is one of the most common neurodegenerative diseases characterized by the progressive loss of dopaminergic (DA) neurons in the substantia nigra compacta (SNc) and aggregation of Lewy bodies in neurons. Although aging, oxidative damage and neuroinflammation have been recognized to play crucial roles in the pathogenesis of PD, the precise etiology remains obscure. Emerging evidence suggests PD is a systemic metabolic disease, and metabolic abnormality correlates with functional alternations in PD
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
- Double (Participant, Investigator)
盲法说明
double-blind
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years Both males and females will be included Negative pregnancy test and effective contraception. Diagnosed Parkinson's disease patient taking Levodopa
排除标准
- •Secondary causes of Parkinsonism Diabetic patients Patients taking anti-inflammatory drugs Atypical parkinsonian syndromes Prior stereotaxic surgery for Parkinson's disease Pregnancy and lactation Suffering from active malignancy Addiction to alcohol and/or drugs Known allergy to the studied medications
研究组 & 干预措施
Control Group
Control group ( Levo-dopa group, n =30 ) who will receive levodopa/carbidopa (50/250 mg) three times daily for 3 months
干预措施: levodopa-carbidopa (Drug)
Metformin group
Patients will receive levodopa/carbidopa (50/250 mg) three times daily plus metformin 500 mg two times daily for 3 months
干预措施: levodopa-carbidopa (Drug)
Metformin group
Patients will receive levodopa/carbidopa (50/250 mg) three times daily plus metformin 500 mg two times daily for 3 months
干预措施: Metformin (Drug)
结局指标
主要结局
• The primary endpoint is the change in The Unified Parkinson's Disease Rating Scale (UPDRS)
时间窗: 3 months
• The primary endpoint is the change in the Unified Parkinson's Disease Rating Scale (UPDRS
次要结局
- The secondary endpoint is estimated by changes in serum biomarkers.(3 months)
研究者
Mostafa Bahaa
Teaching Assistant
Tanta University