NCT05266417招募中2 期
A Randomized, Double-Blind, Placebo-Controlled, Phase II Study to Evaluate the Safety, Tolerability, and Efficacy of Intranasal Insulin and Glutathione as an Add-On Therapy in Subjects With Parkinson's Disease (NOSE-PD)
Gateway Institute for Brain Research6 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2022年2月7日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 56
- 试验地点
- 6
- 主要终点
- Verbal Fluency
研究概览
简要总结
This study will be evaluating the safety and efficacy of insulin and glutathione in subjects with Parkinson's Disease compared to placebo.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 30 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented clinical diagnosis of idiopathic PD
- •Able to administer study drug or have a caregiver throughout the duration of the study to help administer drug
- •Willing to continue diet, exercise and medications reported at baseline consistently throughout participation in the trial. Essential changes are permitted
- •If taking PD medications or any nutraceuticals, must be on a stable dose for at least 30 days prior to Screening Visit. Essential changes will be permitted.
- •If subject is taking chronic antidepressant or an anxiolytic, must be on a stable dose for at least 90 days prior to Screening. Essential changes will be permitted.
排除标准
- •Clinical diagnosis of Type 1 or Type 2 Diabetes Mellitus
- •Glycated hemoglobin (HbA1c) level ≥ 6.5%
- •History of symptomatic hypoglycemia and/or documented plasma glucose levels of ≤ 50 mg/dL with symptoms of hypoglycemia.
- •Mini-Mental State Exam (MMSE) score of ≤ 24 at Screening
- •Positive COVID-19 test at Screening and/or within 30 days of Screening
- •Change in or escalation of dose of a chronic therapeutic agent that has the potential to impair cognitive functioning per investigator within the last 8 weeks of Screening or during the study conduct.
- •Chronic inflammation of nasal cavity, history of recurrent epistaxis, and/or clinically significant medical history of uncontrolled allergic rhinitis, rhino-conjunctivitis, or house dust mite allergy at Screening that may prevent absorption of study treatments.
- •Insufficiently controlled respiratory disease (i.e., asthma, COPD).
- •History of any significant neurologic or psychiatric disease other than PD
- •Current diagnosis of epilepsy and had a history of seizures as an adult within 1 year of Screening, or unexplained recent loss of consciousness, or history of significant head trauma with loss of consciousness
- •History of non-lacunar ischemic and/or hemorrhagic stroke with residual neurologic deficits.
- •Unstable or uncontrolled cardiac disease that could expose the subject to additional safety risks
- •Use of the following medications: Insulin or any other anti-hyperglycemic agent(s) except if used during isolated gestational diabetes, Supplementation with GSH or any medication shown to increase glutathione
研究组 & 干预措施
Active
Experimental
Insulin (Novolin R) and Glutathione (INS-GSH)
干预措施: INS-GSH (Drug)
Control
Placebo Comparator
Placebo
干预措施: Matched Placebos (Drug)
结局指标
主要结局
Verbal Fluency
时间窗: 24 Weeks
F, A and S (FAS) words test
次要结局
- Verbal Fluency(28 Weeks)
- Cognitive Function(Week 24)
- Non-Motor Function(Week 24)
- Motor Function(Week 24)
- Patient Reported Outcome(Week 24)
研究者
研究点 (6)
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