JPRN-jRCT2051230090招募中2 期
Phase 2 randomized double blind controlled study to investigate disease modifying effect, safety and optimal dose of oral semaglutide tablet for patients with Parkinson's disease - MOST-ABLE study
Kimura Yasuyoshi0 个研究点目标入组 99 人开始时间: 2023年8月23日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 99
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 80age old（—）
- 性别
- All
入选标准
- •1) Aged 20-80 years at the time of informed consent
- •2) Diagnosed with PD by a neurologist [In terms of diagnosis, meet the UK Parkinson's Disease Society Brain Bank clinical diagnostic criteria (UKPDSBB criteria) International Parkinson and Movement Disorder Society (MDS) Clinical Diagnostic criteria (MDS-PD criteria, clinically established PD) or MDS-early PD criteria]
- •3) On-time Modified Hoehn and Yahr classification <=2.5
- •4) Receiving stable PD medication for 4 weeks prior to V1. For MAO-B inhibitors, stable dose and dosage for 12 weeks prior to V1.
- •5) With written informed consent
排除标准
- •1) Diagnosed or supected with Parkinson's syndrome other than PD
- •2) Familial PD
- •3) Showing abnormalities with brain MRI or CT that may affect DaTscan results
- •4) Cannot come to the hospital in an off-state
- •5) Moderate-severe depression with PHQ-9>=16
- •6) Cognitive dysfunction with MMSE<=23 or FAB<=11
- •7) Receiving device aided therapy, previous history of irreversible brain surgery, previous history of gene therapy or cell transplantation as PD treatment
- •8) Currently participating in another investigational study and previously participated in investigational study of disease-modifying therapies
- •9) Body mass index<18.5
- •10) Type1 or Type2 diabetes mellitus
- •11) Severe gastrointestinal disorder, severe Gastro esophageal reflux disease and previous history of gastrectomy
- •12) Previous history of Pancreatitis
- •13) Kidney dysfunction with eGFR<30mL/min
- •14) Decompensated cirrhosis
- •15) Diagnosed or supected Thyroid tumor
- •16) Previous history or family history of Multiple endocrine neoplasia type2
- •17) Pregnant, breastfeeding and unable to contraception during the study period
- •18) Receiving medication to be taken upon waking and unable to change or discontinue during the study period
- •19) Eat, drink, or take oral medication within 8 hours prior to taking the study drug
- •20) Previous use of GLP-1 receptor agonists, including semaglutide
- •21) Answer yes to item 4 or item 5 of the C-SSRS suicidal ideation. Current or past suicidal behavior or received treatment for suicidal attempts or plans
- •22) Unable to DaTscan due to alcohol sensitivity
- •23) Other, unqualified for this study decided by investigator
研究者
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