Study of Nasal Insulin to Fight Forgetfulness - Short-Acting Insulin Aspart
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change in cognition
研究概览
简要总结
This pilot clinical trial will examine the effects of intranasal insulin aspart on cognition, daily function, blood and cerebral spinal fluid markers of Alzheimer's disease, and amyloid deposition in the brain. Participants will be randomly assigned to receive insulin aspart or placebo during a 12-week treatment period.
详细描述
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.
This trial will consist of a randomized double-blind, placebo-controlled parallel group trial in which 30 participants with AD or mild cognitive impairment (MCI) receive twice daily intranasal administrations of insulin aspart (20 IU) or placebo (saline), two times per day for 12 weeks. All participants will appoint a "support person" to answer a collateral questionnaire and supervise the administration of the study drug. All participants and study partners will undergo the intensive, structured training program in the self-management of intranasal insulin administration. Cognitive testing and blood collection will occur at baseline, after 6 weeks of treatment, and at the end of the 12 week treatment period. Participants will also receive a lumbar puncture to measure AD biomarkers in the subject's cerebral spinal fluid.
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
- 50 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previous or subsequent diagnosis of Alzheimer's disease or mild cognitive impairment
- •Ability to communicate in English
排除标准
- •Preexisting diabetes
- •Clinically significant elevations in liver function test
- •Clinically significant elevations in lipid profile
- •Prior lumbar lumbar surgeries or other medical conditions that render lumbar punctures unsafe
- •Hemoglobin <8 g/dl
- •Significant neurologic disease that might affect cognition, other than Alzheimer's disease, including stroke, Parkinson's disease, multiple sclerosis, or recent severe head injury (within the last year) with loss of consciousness >30 minutes or with permanent neurologic sequelae
- •Significant medical illness or organ failure, such as uncontrolled hypertension or cardiovascular disease, chronic obstructive pulmonary disease, liver disease, or kidney disease
- •Current use of antipsychotic, anticonvulsant, anxiolytic, anticoagulant or sedative medications
- •Current or previous use of glucose-lowering agents or insulin;
- •Chronic use (≥ 3 times per week) of nasal sprays of any type for any indication
- •Premenopausal status (defined as having had a period within the last year).
研究组 & 干预措施
Insulin Aspart
Fifteen randomly assigned participants with Alzheimer's disease or mild cognitive impairment will receive twice daily intranasal administrations of insulin aspart (20 IU) for 12 weeks.
干预措施: Insulin aspart (Drug)
Placebo
Fifteen randomly assigned participants with Alzheimer's disease or mild cognitive impairment will receive twice daily intranasal administrations of placebo (saline) for 12 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in cognition
时间窗: 6 weeks and 12 weeks
Alzheimer's Disease Assessment Scale-Cognitive Subscale(ADAS-Cog)/mild cognitive impairment (MCI) scores and memory composite (summed Z scores from delayed story and list recall)
次要结局
- MRI measure of cortical thickness in Alzheimer's disease (AD) -vulnerable regions(Baseline and week 12)
- Cerebral spinal fluid (CSF) and blood amyloid-beta, tau protein, and inflammatory markers(Blood - every 6 weeks for 12 weeks; cerebral spinal fluid (CSF) - baseline and week 12)