Creatine to Augment Bioenergetics in Alzheimer's
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in Blood Creatine
研究概览
简要总结
By doing this study, researchers hope to see if creatine monohydrate is a helpful treatment for people with Alzheimer's disease.
详细描述
Alzheimer's disease is a progressive brain disorder that causes memory and thinking problems. Current medications may temporarily help with symptoms but cannot stop the disease from getting worse. As such, new treatments that slow or stop the disease from progressing are needed.
There is some evidence from animal studies that taking creatine monohydrate may improve thinking in Alzheimer's disease and be good for brain health. However, no studies have looked at creatine monohydrate supplementation in humans with Alzheimer's.
Creatine monohydrate is a dietary supplement regulated by the FDA. This is a study that will test if taking creatine monohydrate may be a helpful treatment for people with Alzheimer's disease. In this study, investigators will will evaluate:
- Whether persons with Alzheimer's disease are able to easily take creatine monohydrate for 8 weeks.
- Whether creatine monohydrate affects thinking function in people with Alzheimer's Disease.
- Whether creatine monohydrate affects certain biochemicals in the brain and body.
- Whether creatine monohydrate improves muscle size and strength.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed cognitive impairment due to Alzheimer's disease
- •Agreed cooperation from a study partner
- •Speaks English as primary language
- •Age 60 to 90
- •Stable medication for ≥30 days
- •BMI ≥ 20.0kg/m2
排除标准
- •Insulin-requiring diabetes, cancer requiring chemotherapy or radiation within the past 5 years, or recent cardiac event (i.e., heart attack, etc.)
- •Other neurodegenerative disease
- •Ongoing renal disorder or abnormal renal or liver function
- •Unable to undergo MRI
- •Clinical trial or investigational drug or therapy participation within 30 days of the screening visit
- •Non-English speakers
- •Inability to perform strength testing
- •Weight > 350 lbs.
结局指标
主要结局
Change in Blood Creatine
时间窗: Baseline, 4 weeks, and 8 weeks
Measure of serum creatine levels at baseline, 4 weeks, and 8 weeks.
Adherence to Creatine Monohydrate Intervention
时间窗: 8 weeks
Participants will keep a daily supplement tracker (with the help of a consenting study partner). They will also bring unconsumed creatine monohydrate powder to study visits where study personnel will measure and validate against expected intake.
次要结局
- Change in Cognition(Baseline and 8 weeks)
- Change in Peripheral Mitochondrial Respiration(Baseline and 8 weeks)
- Change in Brain Creatine Status(Baseline and 8 weeks)
- Change in Muscle Strength(Baseline and 8 weeks)
- Change in Muscle Size(Baseline and 8 Weeks)
研究者
Matthew Taylor
Assistant Professor
University of Kansas Medical Center