Device Study for Intranasal Delivery of Insulin
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- CSF Insulin Levels
研究概览
简要总结
The SNIFF Device study will involve using a device to administer insulin through each participant's nose or intra-nasally. Insulin is a hormone that is produced in the body. It works by lowering levels of glucose (sugar) in the blood. This study is measuring how much insulin the device delivers. In addition, this study will look at the effects of insulin or placebo administered intra-nasally using a nebulizer-like device on memory, blood, and cerebral spinal fluid.
详细描述
The aim of this study is to determine the ability of an intranasal delivery device to increase levels of insulin in cerebrospinal fluid (CSF).
A growing body of evidence suggests that insulin plays a role in normal memory processes and that insulin abnormalities may contribute to cognitive and brain changes associated with Alzheimer's disease (AD). Interestingly, insulin administered to the nasal cavity is transported within a few minutes into the brain, but does not affect blood sugar or insulin levels.
The study will consist of a single site, randomized, double-blind trial comparing the acute effects of INI (20 International Units) or placebo delivered with nebulizer-like device on CSF insulin levels, AD biomarkers and memory. At study entry, participants will be randomized to receive either an acute dose of insulin or placebo first, and the other substance on a second visit. Participants who are cognitively normal or who have aMCI (n=30) will be enrolled. The primary outcome measure will be to test the hypothesis that CSF insulin levels will increase 30 minutes after receiving a 20 International Units dose of insulin delivered with a nebulizer-like device, compared to levels achieved 30 minutes after 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Neither participants or site personnel will know whether insulin or saline is being administered. Exceptions will be the study nurse who is directly involved in preparing the insulin or placebo, as well as preparing DSMB reports.
入排标准
- 年龄范围
- 55 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Fluent in English
- •Cognitively normal or diagnosis of aMCI
- •Stable medical condition for 3 months prior to screening visit
- •Stable medications for 4 weeks prior to the screening and study visits
- •Clinical laboratory values must be within normal limits or, if abnormal, must be judged to be clinically insignificant by the study physician
排除标准
- •A diagnosis of dementia
- •History of a clinically significant stroke
- •Current evidence or history in past two years of epilepsy, head injury with loss of consciousness, any major psychiatric disorder including psychosis, major depression, bipolar disorder
- •Diabetes (type I or type II) insulin dependent and non-insulin dependent diabetes mellitus
- •Current or past use of insulin or any other anti-diabetic medication within 5 years of Screening visit.
- •History of cancer five years prior to screening (history of skin melanoma or stable prostate cancer are not exclusionary)
- •History of seizure within past five years
- •Pregnancy or possible pregnancy.
- •Use of anticoagulants warfarin (Coumadin) and dabigatran (Pradaxa)
- •Residence in a skilled nursing facility at screening
- •Use of an investigational agent within two months of screening visit
- •Regular use of alcohol, narcotics, anticonvulsants, antiparkinsonian medications, or any other exclusionary medications
研究组 & 干预措施
Insulin first, then placebo
Participants will be randomly assigned to receive regular insulin (U100, 20 IU) administered with an intranasal nebulizer-like device. Participants in this arm will then receive placebo at visit 3 during second intervention period.
干预措施: Insulin (Drug)
Insulin first, then placebo
Participants will be randomly assigned to receive regular insulin (U100, 20 IU) administered with an intranasal nebulizer-like device. Participants in this arm will then receive placebo at visit 3 during second intervention period.
干预措施: Placebo (Other)
Insulin first, then placebo
Participants will be randomly assigned to receive regular insulin (U100, 20 IU) administered with an intranasal nebulizer-like device. Participants in this arm will then receive placebo at visit 3 during second intervention period.
干预措施: intranasal nebulizer-like device (Device)
Placebo first, then insulin
Participants will be randomly assigned to receive placebo administered with an intranasal nebulizer-like device. At visit 3 during second intervention period, participants in this arm will receive insulin.
干预措施: Insulin (Drug)
Placebo first, then insulin
Participants will be randomly assigned to receive placebo administered with an intranasal nebulizer-like device. At visit 3 during second intervention period, participants in this arm will receive insulin.
干预措施: Placebo (Other)
Placebo first, then insulin
Participants will be randomly assigned to receive placebo administered with an intranasal nebulizer-like device. At visit 3 during second intervention period, participants in this arm will receive insulin.
干预措施: intranasal nebulizer-like device (Device)
结局指标
主要结局
CSF Insulin Levels
时间窗: 30 minutes after intervention administration
Levels of insulin in cerebrospinal fluid after being delivered with the device. This will help to determine the ability of an intranasal delivery device to increase levels of insulin in cerebrospinal fluid (CSF)
次要结局
- The Auditory-Verbal Learning Test (AVLT)(5 minutes before lumbar puncture, and immediately following lumbar puncture)
- CSF Levels of AB42(30 minutes after intervention administration)
- CSF Levels of Total Tau(30 minutes after intervention administration)
- CSF Levels Phospho-tau 181(30 minutes after intervention administration)