Brain Small Chain Fatty Acid Metabolism in Parkinson Disease: Ketones
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 4
- 主要终点
- Glucose Metabolism
研究概览
简要总结
Small exploratory open-label pilot study to assess supplementation of a ketone ester (KetoneAid) as a potential therapy for persons with Parkinson disease (PD), Parkinson Disease Dementia/Lewy Body Dementia (PDD/LBD), and healthy controls.
详细描述
The overarching goal of this study is to investigate glucose metabolic, cognitive, clinical and imaging changes in persons with PD and PDD/LBD before and after a month supplementation of a ketone ester (KetoneAid) in a small open label exploratory clinical trial. Positive findings in this small exploratory pilot trial may support future target engagement studies of ketone supplementation in PD and normal adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy control volunteers over 45 years of age
- •People with Parkinson Disease over 45 years of age
- •People with Parkinson's Disease Dementia or Lewy Body Dementia over 45 years of age
排除标准
- •Participants with contra-indications to MR imaging, including pacemakers or claustrophobia;
- •Evidence of large vessel stroke or mass lesion on MRI
- •Regular use of anti-cholinergic, benzodiazepines, high dose (>100mg QD) of quetiapine, or neuroleptic drugs
- •History of significant GI disease
- •Significant metabolic or uncontrolled medical comorbidity
- •Poorly controlled diabetes
- •Pregnancy or breast feeding
- •Current excessive alcohol use
- •Suicidal ideation
结局指标
主要结局
Glucose Metabolism
时间窗: Pre and post approximately 30 days of intervention
Continuous glucose meter 7-10-day average glucose readings before/after open-label treatment with the ketone ester in patients with PD, Parkinson's disease dementia/Lewy body dementia, and normal controls. Healthy fasting blood glucose ranges from 70 to 99 milligrams per deciliter (mg/dL), with a healthy maximum of 180 mg/dL within 2 hours of eating meals.
Clinical Dementia Rating Scale Score
时间窗: Pre and post approximately 30 days of intervention
The clinical dementia rating scale is a measure of functional and cognitive performance relevant to dementia. It is scored from 0 (normal) to 3 (severe dementia). The clinical dementia rating scale will be assessed in patients with Parkinson's disease, Parkinson's disease dementia/Lewy body dementia, and healthy controls before and after open-label treatment with the ketone ester.
次要结局
未报告次要终点
研究者
Nicolaas Bohnen, MD, PhD
Professor
University of Michigan