jRCT2051230090进行中（未招募）不适用
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)
未提供0 个研究点目标入组 99 人开始时间: 2023年11月6日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 99
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 20age old over 至 80age old under（—）
- 性别
- All
入选标准
- •Aged 20-80 years at the time of informed consent
- •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]
- •On-time Modified Hoehn and Yahr classification <=2.5
- •Receiving stable PD medication for 4 weeks prior to V
- •For MAO-B inhibitors, stable dose and dosage for 12 weeks prior to V
- •With written informed consent
排除标准
- •Diagnosed or supected with Parkinson's syndrome other than PD
- •Familial PD
- •Showing abnormalities with brain MRI or CT that may affect DaTscan results
- •Cannot come to the hospital in an off-state
- •Moderate-severe depression with PHQ-9>=16
- •Cognitive dysfunction with MMSE<=23 or FAB<=11
- •Receiving device aided therapy, previous history of irreversible brain surgery, previous history of gene therapy or cell transplantation as PD treatment
- •Currently participating in another investigational study and previously participated in investigational study of disease-modifying therapies
- •Body mass index<18.5
- •Type1 or Type2 diabetes mellitus
- •Severe gastrointestinal disorder, severe Gastro esophageal reflux disease and previous history of gastrectomy
- •Previous history of Pancreatitis
- •Kidney dysfunction with eGFR<30mL/min
- •Decompensated cirrhosis
- •Diagnosed or supected Thyroid tumor
- •Previous history or family history of Multiple endocrine neoplasia type2
- •Pregnant, breastfeeding and unable to contraception during the study period
- •Receiving medication to be taken upon waking and unable to change or discontinue during the study period
- •Eat, drink, or take oral medication within 8 hours prior to taking the study drug
- •Previous use of GLP-1 receptor agonists, including semaglutide
- •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
- •Unable to DaTscan due to alcohol sensitivity
- •Other, unqualified for this study decided by investigator
结局指标
主要结局
-
Change in clinically defined off-state MDS-UPDRS part 3 score at 48week
次要结局
未报告次要终点
研究者
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