A Double-blinded Placebo-controlled Single-center Study to Evaluate the Efficacy of Intranasal Insulin 40 International Units Day as Treatment for Subjects With Parkinson Disease and Multiple System Atrophy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change in Verbal Fluency FAS (F, A or S Words) Total Score
研究概览
简要总结
Parkinson disease (PD) and multiple system atrophy (MSA) are progressive neurodegenerative disorders characterized by abnormal accumulation of α-synuclein. There is no effective treatment that can slow down the disease progression and both disorders are associated with severe cognitive decline. It was shown that intranasal insulin (INI) improves learning and memory in healthy and cognitively impaired non-diabetic adults.
The proof-of-concept, randomized, placebo-controlled, cross-over pilot study ( NCT01206322) has shown that a single 40 international units dose of intranasal insulin improves visuospatial memory in diabetes and control subjects.
This proposal includes randomized, double blinded, placebo-controlled trial of intranasal insulin (40 international units daily) in treatment of PD and MSA.
The study will evaluate 22 patients with PD and 22 patients with MSA. Total duration of the study will be 2 years. The primary goal is to assess the efficacy of INI in treatment of cognitive abnormalities in both PD and MSA. The primary efficacy end point will be change of the cognitive scale ratings.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females older than 17 years.
- •Clinical diagnosis of Parkinson disease or multiple system atrophy.
- •Provide written informed consent to participate in the study.
- •Understand that they may withdraw their consent at any time.
排除标准
- •Women who are pregnant or lactating.
- •In the investigator's opinion, have significant systemic, hepatic, cardiovascular, renal or other illness that can interfere based on investigator judgment with the trial.
- •History of dementia.
- •Unable to walk without help for at least 1 minute.
- •History of allergic reaction to insulin.
- •The presence of inflammation of nasal cavity that may prevents absorption of insulin.
研究组 & 干预措施
Insulin
40 IU of intranasal insulin daily
干预措施: Intranasal Insulin (Drug)
Placebo
Placebo arm using intranasal normal saline
干预措施: Intranasal Insulin (Drug)
结局指标
主要结局
Change in Verbal Fluency FAS (F, A or S Words) Total Score
时间窗: Baseline and post-treatment
Changes in Verbal Fluency FAS (a total number of F, A or S words) generated after 4 weeks of treatment compared to baseline, FAS total score is a sum of F,A, and S raw scores. The verbal fluency FAS test is used to assess phonemic fluency and verbal memory. Participants are asked to name words starting with letters F, A and S over one minute interval. The unit is a on scale, the normative data are adjusted for age and sex. The higher score means better verbal fluency.
次要结局
- Modified Hoehn and Yahr Scale(Baseline and post-treatment)
- Cognitive Impairment Using Montreal Cognitive Assessment (MoCA)(Baseline and post-treatment)
- Beck Depression Inventory Score (BDI)(Baseline and post-treatment)
研究者
Peter Novak
Former Faculty member
University of Massachusetts, Worcester