Anti-Diabetic Medications to Fight Parkinson's Disease and Lewy Body Dementia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Change in Movement Disorder Society- Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Score
研究概览
简要总结
The purpose of this study is to test the hypothesis that DPP4 inhibitors and SGLT2 inhibitors are well tolerated and have beneficial neurological effects, specifically for Parkinson's disease and Lewy body dementia.
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)
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parkinson's disease or Lewy Body Dementia (diagnosis confirmed by neurologist at Mayo Clinic) with stable neurological treatment in the past approximately three months.
- •Glucose intolerance or mild diabetes: The American Diabetes Association criteria for pre-diabetes/ glucose intolerance includes fasting glucose 100-125, random glucose 140-199, or hemoglobin A1C 5.7-6.4% and diabetes is > 125 mg/dL, > 200 mg/dL, and 6.5% or greater, respectively (40). It has been previously reported that 50-80% of individuals with Parkinson's disease have abnormal glucose tolerance (17), so this should not limit recruitment.
排除标准
- •Use of insulin or other anti-diabetes medications other than metformin.
- •Contraindication to taking a DPP4 inhibitor or SGLT2 inhibitor including: allergy, history of angioedema, pancreatitis, active gallbladder disease, renal impairment with EGFR < 45).
- •Bleeding disorder, use of anticoagulants, thrombocytopenia, or severe anemia.
- •Use of high dose steroids.
- •Current systemic chemotherapy.
- •Pregnancy or breastfeeding.
- •Recent (within 30 days) or recurrent (defined as more than one in the past 12 months) urinary tract infection or yeast infection.
- •Other contraindication that would make study participation unsafe or make study related data unable to be interpreted.
研究组 & 干预措施
Sitagliptin Group
Subjects will receive sitagliptin for the approximately 4-week treatment period.
干预措施: Sitagliptin (Drug)
Dapagliflozin Group
Subjects will receive dapagliflozin for the approximately 4-week treatment period.
干预措施: Dapagliflozin (Drug)
Placebo Group
Subjects will receive placebo for the approximately 4-week treatment period.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Movement Disorder Society- Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Score
时间窗: Baseline, 4 weeks
The Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) measures the severity and progression of Parkinson's disease. It consists of four subscales that assess various aspects of the disease, including: Non-motor experiences of daily living-Part 1 (13 questions), Motor experiences of daily living-Part 2 (13 questions), Motor examination-Part 3 (33 questions), and Motor complications-Part 4 (6 questions). Each subscale is calculated as a sum of the questions, rated from 0 (normal)-4 (severe). Thus, the subscale score ranges are: Non-motor experiences of daily living-Part 1 (range 0-52), Motor experiences of daily living-Part 2 (range 0-52), Motor examination-Part 3 (range 0-132), and Motor complication-Part 4 (range 0-24) with higher scores indicating more severe Parkinson's Disease.
Change in Mini Mental State Examination (MMSE) Score
时间窗: Baseline, 4 weeks
The MMSE consists of 11 questions used by clinicians to check for cognitive impairment. Total scores range from 0 to 30 with lower scores indicating cognitive impairment.
次要结局
- Change in Fasting Glucose(Baseline, 4 weeks)
- Change in Orthostatic Blood Pressure(Baseline, 4 weeks)
研究者
Jessica R. Wilson
Principal Investigator
Mayo Clinic