EUCTR2019-000732-26-SE进行中（未招募）1 期
Effect of Exenatide on disease progression in early Parkinson's disease.
Stockholm Health Care Services0 个研究点目标入组 60 人开始时间: 2019年5月7日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Diagnosis of clinically probable Parkinson’s disease.
- •Males or Females.
- •Hoehn and Yahr stage = 2 in the ON medication state.
- •Patients are on levodopa treatment.
- •No need for extended treatment adjustment, no significant motor fluctuations during the last year.
- •All patients will be =25 and =80 years of age.
- •Ability to self-administer, or to arrange carer administration of the trial drug.
- •Signed informed consent to participate in the trial.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •Atypical or other causes of parkinsonism.
- •Prior intra-cerebral surgical intervention for Parkinson’s disease. Patients who have previously undergone Deep Brain Stimulation, intra-cerebral administration of growth factors, gene therapy or cell therapies will not be eligible.
- •Already actively participating in a trial of a device, drug or surgical treatment for Parkinson’s disease.
- •Previous exposure to Exenatide.
- •Known abnormality on CT or MRI brain imaging considered likely to compromise compliance with trial protocol/FDG-PET acquisition.
- •Patients with body mass index less than 18.5.
- •Patients with diabetes mellitus type 1.
- •Patients with prediabetes, or T2DM.
- •History of pancreatitis.
- •Severe gastrointestinal disease including gastroparesis.
- •History of alcoholism.
- •History of severe cardiac disease.
- •History of pancreas cancer.
- •History or suspicion of thyroid cancer.
- •Personal or family history of medullary thyroid cancer.
- •Patients with Multiple Endocrine Neoplasia 2 (MEN2) syndrome.
- •End-stage renal disease or creatinine clearance < 50 ml/min.
- •Hyperlipidaemia.
- •Concurrent treatment with warfarin.
- •Concurrent severe depression, defined as MADRS score more than 16.
- •Concurrent dementia, defined as MMSE < 22.
- •Pregnancy and Breastfeeding.
- •Known hypersensitivity or allergy or intolerance to GLP-1.
- •Known hypersensitivity to Exenatide or any of its excipients.
- •Potential participants who lack the capacity to give informed consent
- •Any medical, psychiatric or other condition which in the investigator’s opinion compromises the potential participant's ability to participate in the trial.
研究者
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