Therapeutic Effects of Intranasal Insulin Administration in AD
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 173
- 试验地点
- 1
- 主要终点
- Changes in cognition
研究概览
简要总结
The purpose of this study is to find out if insulin, when administered as a "nasal spray" into the nasal passages, improves memory in adults with mild cognitive impairment (MCI) or Alzheimer's disease.
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 study will consist of a randomized double-blind, placebo-controlled parallel group trial in which 90 participants with AD or MCI receive daily intranasal administrations of either insulin (10 or 20 IU twice a day for a total dose of 20 or 40 IU per day) or placebo (saline twice a day) for 4 months. The study will examine the effects of intranasal insulin administration on cognition, cerebral glucose metabolism, and β-amyloid (Aβ) in cerebrospinal fluid (CSF) and plasma, testing the hypothesis that daily intranasal insulin administration for 4 months will facilitate memory for adults with AD, and adults with mild cognitive impairment (MCI). A subset of participants will have the option to participate in 2 sub-studies: PET scans (prior to and at the end of treatment) to determine whether intranasal insulin increases cerebral glucose metabolism; lumbar punctures (LPs) before and at the end of treatment to determine effects of intranasal insulin administration on CSF Aβ levels.
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
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 55 or greater
- •Good physical health
- •Memory impairment with a diagnosis of mild cognitive impairment (MCI) or Alzheimer's disease (AD)
- •Participants on stable doses of Memantine (Namenda) or cholinesterase inhibitors will be eligible
排除标准
- •Chronic sinus problems/allergies with chronic use of nasal decongestants or antihistamines
- •Significant neurologic disease that might affect cognition (other than AD), such as stroke, Parkinson's disease, multiple sclerosis, severe head injury with loss of consciousness for more than 30 minutes or with permanent neurologic symptoms
- •Significant medical illness or organ failure, such as uncontrolled hypertension or cardiovascular disease, chronic obstructive pulmonary disease, liver disease, or kidney disease
- •Preexisting diabetes or current or previous use of hypoglycemic agents or insulin; participants will be excluded if they have a fasting blood sugar greater than 165 on baseline OGTT
- •Clinically significant elevations in liver function tests, cholesterol, or triglycerides
- •Major psychiatric disorders (e.g., untreated major depression and schizophrenia)
- •Chronic use of the following types of medications: anti-psychotic, anxiolytic, and opiates
研究组 & 干预措施
1
saline
干预措施: Placebo (Drug)
2
10 Units
干预措施: Regular Insulin (Drug)
3
20 Units
干预措施: Regular Insulin (Drug)
结局指标
主要结局
Changes in cognition
时间窗: every 8 weeks for 16 weeks, again at 8 weeks post-treatment (24 weeks)
glucose metabolism
时间窗: every 8 weeks for 16 weeks, again at 8 weeks post-treatment (24 weeks)
plasma biological markers
时间窗: every 8 weeks for 16 weeks, again at 8 weeks post-treatment (24 weeks)
次要结局
- CSF biological markers(every 8 weeks for 16 weeks, again at 8 weeks post-treatment (24 weeks))
- cerebral glucose metabolism(every 8 weeks for 16 weeks, again at 8 weeks post-treatment (24 weeks))