Measurement of Insulin Levels in Cerebral Spinal Fluid (CSF) of Healthy Adults After a Single Intranasal Dose
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Insulin Concentration Over Time - Cerebrospinal Fluid
研究概览
简要总结
The purpose of this study is to find out whether insulin, a drug approved by the FDA for the treatment of diabetes mellitus, reaches the brain and spinal cord when delivered as a nasal spray (intranasally). Intranasal insulin has been shown to improve memory and mood in patients with mild cognitive impairment and dementia, but more evidence is needed to support the ability to effectively target the brain through intranasal routes.
12 healthy adults will be randomly assigned to receive a single dose of either 40 units ("low dose" group) or 80 units ("high dose" group) of insulin. Participants will undergo image-guided lumbar puncture (spinal tap) performed by a study radiologist. Samples of cerebrospinal fluid (a fluid surrounding the brain and spinal cord) and blood will be collected at 5 timepoints during the lumbar puncture: once prior to the administration of intranasal insulin, and again at 10, 20, 30, and 40 minutes after the dose is given. Samples will be tested to determine the level of insulin detected in the cerebrospinal fluid and blood at each time point. Results of this study will provide essential information about the ability of the SipNose device to effectively deliver insulin to the central nervous system of humans as measured in the cerebrospinal fluid.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is between ≥18 and ≤ 35 years of age
- •Subject's body mass index is between >=18.5 and <=24.9
- •Subject must be proficient in speaking English to comply with instructions and measures for the study
- •Subject can provide written informed consent
- •Female subjects must have either: (1) a negative pregnancy test at the screening and treatment visits OR (2) be at least 2 years post-menopausal/surgically sterile.
排除标准
- •Subject has medical history and/or clinically determined disorders: chronic sinusitis, previous nasal and/or oto-pharyngeal surgery and severe deviated septum and/or other anomalies.
- •Subject has history of any of the following: active and significant central nervous system, psychiatric illness, pulmonary, or cardiovascular disorders or any other clinically relevant abnormality that inclusion would pose a safety risk to the subject as determined by investigator
- •Subject has participated in a clinical trial investigation within 3 months of this study.
- •Subject has an insulin allergy
- •Subject has Insulin-dependent diabetes
- •Subject is pregnant or breast feeding
- •Contraindication to spinal tap or other safety factors that preclude lumbar puncture in the investigator's opinion
研究组 & 干预措施
Low dose Intranasal Insulin
One dose of 40 international units of regular insulin administered intranasally using the SipNose SP1N1C1 device.
干预措施: Low dose Regular Insulin (Drug)
High dose Intranasal Insulin
One dose of 80 international units of regular insulin administered intranasally using the SipNose SP1N1C1 device.
干预措施: High dose Regular insulin (Drug)
结局指标
主要结局
Insulin Concentration Over Time - Cerebrospinal Fluid
时间窗: 0-40 minutes post-intranasal administration
Insulin concentration detected in cerebrospinal fluid at 5 time points (pre-insulin dose; and 10, 20, 30 ,40 minutes after dose). Values will be reported as μIU/mL. Higher values indicate a greater concentration of insulin in the cerebrospinal fluid. Concentrations for each time point (overall and by dose) will be reported as a mean +/- standard deviation. The limit of detection of the assay was 0.15mU/L (0.0065µg/L).
Cmax of Insulin Concentration - Cerebrospinal Fluid
时间窗: 0-40 minutes post-intranasal administration
CSF insulin concentration will also be reported by Cmax (peak concentration)
Tmax of Insulin Concentration - Cerebrospinal Fluid
时间窗: 0-40 minutes post-intranasal administration
CSF insulin concentration will also be reported by Tmax (time of peak concentration)
AUC (Area Under the Curve) of Insulin Concentration - Cerebrospinal Fluid
时间窗: 0-40 minutes post-intranasal administration
CSF insulin concentration will also be reported by AUC (area under the curve, measured as time x concentration).
次要结局
- AUC (Area Under the Curve) of Insulin Concentration - Serum(0-40 minutes post-intranasal administration)
- Tmax of Insulin Concentration - Serum(0-40 minutes post-intranasal administration)
- Insulin Concentration Over Time - Serum(0-40 minutes post-intranasal administration)
- Cmax of Insulin Concentration - Serum(0-40 minutes post-intranasal administration)