NCT06951334尚未招募不适用
Clinical Trial of Vildagliptin in Early Parkinson's Disease
First Affiliated Hospital, Sun Yat-Sen University0 个研究点目标入组 66 人开始时间: 2025年6月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 66
- 主要终点
- The change in the third part of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) after 12 months of oral Vildagliptin treatment compared to baseline
研究概览
简要总结
Investigating the efficacy of Vildagliptin in delaying the progression of Parkinson's disease.
详细描述
Exploring the effectiveness and safety of vildagliptin in delaying the progression of Parkinson's disease.
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
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1: Patients aged 40 to 75 years who were diagnosed with Parkinson's disease according to the UK Brain Bank criteria within the past three years.
- •2: Participants must have received an optimized and stable dopaminergic medication regimen (dopamine agonists, levodopa, or monoamine oxidase B [MAOB] inhibitors, or combinations of these medications) determined by the study site investigators for at least one month prior to the baseline initiation of the trial drug, with the expectation that the participants will be able to continue this regimen for at least six months.
- •3: Sign the informed consent form
排除标准
- •1: The key exclusion criterion is a score of at least 3 on the Hoehn and Yahr scale (ranging from 1 to 5, with higher scores indicating more severe disability), which indicates that Parkinson's disease has led to at least mild to moderate bilateral motor involvement due to some postural instability.
- •2: Presence of motor fluctuations or motor complications (or both).
- •3: The presence of severe psychiatric disorders, such as severe (treatment-resistant) anxiety, depression, or schizophrenia, that cannot be effectively controlled by medication.
- •4: Atypical or secondary Parkinsonism
- •5: A score of 18 or lower on the Montreal Cognitive Assessment (MoCA) (range: 0 to 30, with a score of 26 or higher indicating normal cognitive function), indicating at least mild cognitive impairment.
- •6: Diabetes mellitus (Type 1 and Type 2), as well as prior treatment with dipeptidyl peptidase-4 (DPP-4) inhibitors or glucagon-like peptide-1 (GLP-1) receptor agonists.
- •7: Individuals with severe renal impairment (creatinine clearance <30 ml/min), active liver disease, history of drug or alcohol abuse, idiopathic pancreatitis, chronic pancreatitis, or a history of pancreatectomy.
- •8: Individuals with a body mass index (weight in kilograms divided by the square of height in meters) less than 18.5, or those with a weight change exceeding 5 kilograms within the 3 months prior to screening.
- •9: Currently participating in other relevant clinical trials involving pharmacological or surgical treatments.
- •10: Other situations where the investigator believes that the subject is unable to participate in or cooperate with the entire assessment process of the clinical trial.
研究组 & 干预措施
Conventional medication plus Vildagliptin treatment group
Experimental
Traditional dopamine preparations combined with vildagliptin treatment
干预措施: Vildagliptin 50 mg bid (Drug)
结局指标
主要结局
The change in the third part of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) after 12 months of oral Vildagliptin treatment compared to baseline
时间窗: baseline, pre-intervention；12 months，month 12
MDS-UPDRS Part III mainly includes motor symptoms (total score 0-132 points), with scores ranging from 0 to 132 The higher the symptom, the more severe it is.
次要结局
未报告次要终点
研究者
Zhang Nu
Prof
First Affiliated Hospital, Sun Yat-Sen University
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