Study of Nasal Insulin to Fight Forgetfulness (SNIFF) - 3-Week Aptar CPS Device
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 40
- 主要终点
- Percentage of Prescribed Dose Taken
研究概览
简要总结
The SNIFF 3-Week Aptar Device study will involve using a device to administer insulin or placebo 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 an intranasal delivery device on memory, blood, and cerebrospinal fluid (CSF).
详细描述
The proposed study will examine whether an intranasal delivery device can be used by adults with preclinical Alzheimer's disease (cognitively normal but with abnormal brain levels of the hallmark peptide Aβ) to reliably deliver insulin or placebo four times daily over a 4 week period. We will also examine effects of treatment on cognition, CSF biomarkers, and cerebral perfusion. If successful, information gained from the study will inform the design of future Phase III trials of intranasal insulin.
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 which drug intervention (insulin or placebo) is being administered. Exceptions will be the Study Nurse who is directly involved in preparing the insulin or placebo.
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
- •Age 55 to 85 (inclusive)
- •Fluent in English
- •Cognitively normal or diagnosis of amnestic mild cognitive impairment (aMCI) or mild Alzheimer's disease (AD)
- •Amyloid positive by positron emission tomography (PET) or cerebrospinal fluid (CSF) criteria
- •Stable medical condition for 3 months prior to screening visit
- •Stable medications for 4 weeks prior to the screening and study visits (exceptions may be made on a case by case basis by the study physician)
- •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 other than Alzheimer's disease (AD)
- •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 regular use of insulin or any other anti-diabetic medication within 2 months of screening visit
- •History of seizure within past five years
- •Pregnancy or possible pregnancy
- •Use of anticoagulants
- •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, anti-parkinsonian medications, or any other exclusionary medications (exceptions may be made on a case by case basis by the study physician)
研究组 & 干预措施
Humulin® R U-100
Twenty randomly assigned participants with Alzheimer's disease or mild cognitive impairment will receive intranasal administrations of Humulin® R U-100 (40 IU) four times daily for 3 weeks.
干预措施: Insulin (Humulin® R U-100) (Drug)
Humulin® R U-100
Twenty randomly assigned participants with Alzheimer's disease or mild cognitive impairment will receive intranasal administrations of Humulin® R U-100 (40 IU) four times daily for 3 weeks.
干预措施: Aptar Pharma CPS Intranasal Delivery Device (Device)
Placebo
Twenty randomly assigned participants with Alzheimer's disease or mild cognitive impairment will receive intranasal administrations of placebo (insulin diluent) four times daily for 3 weeks.
干预措施: Placebo (Drug)
Placebo
Twenty randomly assigned participants with Alzheimer's disease or mild cognitive impairment will receive intranasal administrations of placebo (insulin diluent) four times daily for 3 weeks.
干预措施: Aptar Pharma CPS Intranasal Delivery Device (Device)
结局指标
主要结局
Percentage of Prescribed Dose Taken
时间窗: Week 4
Participant self-reported medication adherence information will be calculated by study staff on a 0%-100% scale. A score below 80% indicates low medication adherence and a score of 80% or higher indicates high medication adherence.
次要结局
- Change in Cerebrospinal Fluid (CSF) Levels of Phospho-Tau 181(Baseline to Week 8)
- Change in the 14-item Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog 14) Score(Baseline to Week 8)
- Change in Cerebrospinal Fluid (CSF) Levels of Total Tau(Baseline to Week 8)
- Change in amyloid β-peptide (Aβ) 42 (Aβ42) in Cerebrospinal Fluid (CSF)(Baseline to Week 8)
- Change in the Preclinical Alzheimer Cognitive Composite 5 (PACC5) Z-Score(Baseline to Week 8)
- Change in Cerebrospinal Fluid (CSF) Insulin Levels(Baseline to Week 8)
- Change in amyloid β-peptide (Aβ) 40 (Aβ40) in Cerebrospinal Fluid (CSF)(Baseline to Week 8)
- Change in Cerebrospinal Fluid (CSF) Levels of Phospho-Tau 217(Baseline to Week 8)