Study of Nasal Insulin to Fight Forgetfulness - Long-acting Insulin Detemir - 21 Days (SNIFF-LONG 21)
研究概览
详细说明
It is well-known that insulin, a hormone that is naturally secreted by the pancreas, plays an important physiological role by regulating blood sugar levels in the body. The investigators now know that insulin plays many important roles in the brain as well. Insulin seems to be especially active in the part of the brain that corresponds to learning and memory. Studies have shown that when people have insufficient insulin in the brain (which, for example, is the case with Type-II diabetes), they are increasingly at risk to develop memory problems and Alzheimer's disease. In a past study, the investigators administered intravenous insulin to participants and found that it improves their memory. However, that particular method would not be a practical intervention for people with Alzheimer's disease due to the risk of hypoglycemia or exacerbation of insulin resistance. Instead, the investigators use an "intranasal" method of administration, in which the insulin is inserted into a device, and administered intranasally. In this method, the insulin travels directly to the brain, and bypasses the body. Our past studies have also demonstrated that this can be a reliable way to improve memory, and it does not change the body's blood glucose levels.
In our past studies, the investigators have used regular insulin, which lasts about 3-4 hours and creates a similar "spike" in insulin that one would have after eating a meal. However, in normal physiology, the pancreas also releases small and more constant "pulses" of insulin throughout the day and night, establishing a base level of insulin. Accordingly, several longer-lasting types of insulin are now available that last closer to 10-12 hours, mimicking that base level of insulin. The current study uses a long-lasting type of insulin called "insulin detemir," to determine if learning and memory will benefit from a more constant supplement of insulin. the investigators want to determine whether this treatment can benefit people who already have a memory impairment-either they already have a diagnosis of Alzheimer's disease or are diagnosed with mild cognitive impairment, a condition that precedes Alzheimer's disease, and whether a lower or higher dose of insulin detemir is more effective. The investigators will examine cognition, daily function, and different markers of Alzheimer's disease that are in the blood as outcome measures.
The investigators have these specific aims:
- The investigators will test the hypothesis that compared to placebo, three weeks of treatment with intranasal insulin detemir will improve cognition and function in adults with Alzheimer's Disease (AD) or Mild Cognitive Impairment (MCI).
- The investigators will determine which of two doses of intranasal insulin detemir produces the greatest improvement in cognition and daily function relative to placebo for adults with AD or MCI.
To examine these hypotheses, the investigators are recruiting approximately 60 participants who have been diagnosed with AD or MCI. They will be randomly selected to take a lower dose of insulin detemir, a higher dose of insulin detemir, or saline (which is an inactive substance and will serve as a placebo). Cognition and the level of daily function will be tested before they begin the study drug, and after 3 weeks of the study drug. The investigators will also measure glucose tolerance and take blood samples to measure markers of AD in the blood.
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
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Washington
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Seattle、Washington、美国、98108
- VA Puget Sound Health Care System
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age 50-89
- Diagnosed with mild cognitive impairment, or mild/moderate AD
Exclusion Criteria:
- Excessively high or low blood pressure, heart rate
- BMI greater than 34
- Pre-existing diabetes not controlled by exercise
- Previous/current use of insulin
- Significant elevations in lipids, liver enzymes
- Menstrual period within the last 12 months
- Significant neurological or medical disorder (other than AD)
- Significant use of nasal decongestants
- Current use of anti-psychotic, anti-convulsive, anxiolytic, glucocorticoids, or sedative medications
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
安慰剂比较:盐水
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saline, taken twice per day for a 3 week duration
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实验性的:Low Dose Insulin Detemir (10IU bid)
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10IU of insulin detemir, administered intranasally twice per day for a 3 week duration
其他名称:
20IU insulin detemir, administered intranasally twice per day for a 3 week duration
其他名称:
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实验性的:High Dose Insulin Detemir (20IU bid)
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10IU of insulin detemir, administered intranasally twice per day for a 3 week duration
其他名称:
20IU insulin detemir, administered intranasally twice per day for a 3 week duration
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Verbal Memory Composite
大体时间:Change from Baseline in Verbal Memory at 3 Weeks
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The composite will consist of the weighted sum of Immediate + Delayed Story Recall and Immediate +Delayed List Recall
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Change from Baseline in Verbal Memory at 3 Weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Neuropsychological Test of Executive Function 1
大体时间:Change from Baseline in Executive Functioning at 3 Weeks
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Computerized Dot Counting Test (test of executive functioning)
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Change from Baseline in Executive Functioning at 3 Weeks
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Glucose Tolerance
大体时间:Change from Baseline in Glucose Tolerance at 3 Weeks
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Subjects will undergo oral glucose tolerance test (OGTT) to assess glucose tolerance
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Change from Baseline in Glucose Tolerance at 3 Weeks
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Functional Ability
大体时间:Change from Baseline in Functional Ability at 3 Weeks
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Subjects will have a collateral informant (i.e., spouse or friend) rate the subjects' ability to carry out activities of daily living on the Dementia Severity Rating Scale.
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Change from Baseline in Functional Ability at 3 Weeks
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Plasma biomarkers of AD
大体时间:Change from Baseline in Plasma Biomarkers at 3 Weeks
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Plasma Abeta (ABeta 38, ABeta 40, and Abeta 42) and Tau (total tau and phosphorylated tau) will be measured in each subject.
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Change from Baseline in Plasma Biomarkers at 3 Weeks
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Neuropsychological Test of Executive Functioning 2
大体时间:Change from Baseline in Executive Functioning at 3 Weeks
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Computerized Stroop Test
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Change from Baseline in Executive Functioning at 3 Weeks
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Neuropsychological Tests of Visual Working Memory
大体时间:Change from Baseline in Visual Working Memory at 3 Weeks
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Benton Visual Retention Test Form F&G (a test of visual working memory)
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Change from Baseline in Visual Working Memory at 3 Weeks
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合作者和调查者
调查人员
- 首席研究员:Suzanne Craft, PhD、VA Puget Sound Health Care System; University of Washington School of Medicine
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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