The Effect of Growth Hormone Releasing Hormone on Cognitive Function in Individuals With Mild Cognitive Impairment
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Cognitive Function measured by SLUMS
研究概览
简要总结
This study is examining the effects of growth hormone releasing hormone (GHRH) on mild cognitive impairment (MCI). GHRH will be given at a dose of 1mg/day for 10 weeks to subjects with MCI as well as healthy controls.
详细描述
Subjects with MCI as well as healthy controls will be given GHRH at a dose of 1mg/day for 10 weeks.
This study is designed to investigate the effects of GHRH on the following things: 1) cognitive function as measured by our neuropsychologist with a series of short tests; 2) brain activity as measured by fMRI 3) lean and fat mass of your body as measured by DEXA; 4) physical function as measured by a walking test.
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
- Triple (Participant, Care Provider, Investigator)
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 years
- •Ability to sign consent form (score ≥ on the Mini Mental State Examination, MMSE)
- •MCI group: MMSE scores of 23 - 26
- •Normal Control Group: MMSE scores of 27 - 30
排除标准
- •A neurologic condition other than MCI which might cause cognitive impairment
- •Baseline serum IGF-1 concentration greater than the midrange for healthy young adults (300ng/ml)
- •Presence of a pacemaker or metal implant
- •Heart Failure
- •Active malignancy
- •Carpal tunnel syndrome
- •Disruption of the hypothalamic pituitary axis such that the pituitary is expected to be insensitive to growth hormone secretagogues such as GHRH
- •Known allergy to tesamorelin or mannitol
- •Pregnancy
- •Significant heart, liver, kidney, blood or respiratory disease
- •Active cancer
- •Recent (within 6 months) treatment with anabolic steroids, GHRH or corticosteroids
- •Alcohol or drug abuse
- •MMSE < 23
- •Less than 12 years of education
- •Significant findings on screening tests, including but not limited to, blood counts, blood biochemistries, urinalysis, drug screening, HIV test, hepatitis panel, electrocardiogram
- •Other medical conditions deemed exclusionary by the study investigators
研究组 & 干预措施
Mild Cognitive Impairment, Placebo
Subjects aged 55 - 85 years, scored between 23- 26 on screening Mini Mental Status Exam, receiving placebo Growth Hormone Releasing Hormone (GHRH).
干预措施: Placebo Growth Hormone Releasing Hormone (Drug)
Non-cognitively impaired, Placebo
Subjects aged 55- 85 years, scored between 27-30 on screening Mini Mental Status Exam, receiving placebo Growth Hormone Releasing Hormone (GHRH).
干预措施: Placebo Growth Hormone Releasing Hormone (Drug)
Mild Cognitive Impairment, GHRH
Subjects aged 55 - 85 years, scored between 23- 26 on screening Mini Mental Status Exam, receiving active Growth Hormone Releasing Hormone (GHRH).
干预措施: Growth Hormone Releasing Hormone (GHRH) (Drug)
Non-cognitively impaired, GHRH
Subjects aged 55 - 85 years, scored between 27-30 on screening Mini Mental Status Exam, receiving active Growth Hormone Releasing Hormone (GHRH).
干预措施: Growth Hormone Releasing Hormone (GHRH) (Drug)
结局指标
主要结局
Cognitive Function measured by SLUMS
时间窗: 10 weeks
Cognitive function at 10 weeks measured by the St Louis University Mental Status (SLUMS)
Brain Perfusion measured by fMRI
时间窗: 10 weeks
Brain Perfusion at 10 week measured by MRI
Brain Morphology measured by MRI
时间窗: 10 weeks
Brain Morphology at 10 weeks measured by MRI
次要结局
- Body composition measured by DEXA(10 weeks)
- Physical Function measured by 6 minute walking test(10 weeks)