Functional and Metabolomic Biomarkers of Mitochondrial Dysfunction in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- NAD(H) metabolites
研究概览
简要总结
This study evaluates metabolic and functional parameters in the skeletal muscle of Parkinson's disease patients for comparison to a set of healthy age-matched controls.
详细描述
The goal of this study is to identify the unique signature of bioenergetic markers and mitochondrial (dys)function in muscle of individuals with PD, who are 65-85 of age, read and speak English, have a Hoehn & Yahr score between 2 and 3 (bilateral disease, not severely disabled) and have a clinical diagnosis of PD. Bioenergetic markers and muscle functional properties will be compared to a control dataset collected over the last few years from healthy elderly subjects in the same age range to provide a foundation for future intervention studies.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 65-85 years.
- •Ability to attend a 3-hour study visit in Seattle, WA.
- •Ability to read and speak English.
- •Hoehn & Yahr Stage 2-
- •(bilateral disease, not severely disabled.)
排除标准
- •Any contra-indication to magnetic resonance imaging
- •A history of epilepsy, stroke, brain surgery, or structural brain disease.
- •The presence of other serious illnesses
- •Current or recent enrollment in a clinical trial involving an investigational product or device.
- •Supplementation with NAD, nicotinamide mononucleotide (NMN), nicotinamide riboside (NR), and other nutraceuticals designed to target NAD for 30 days prior to baseline study visit.
- •Current drug or alcohol use or dependence.
- •Inability/unwillingness to provide informed consent. (e.g. diagnosis of dementia, confusion about study goals or participation.)
- •Acute infection (e.g. upper respiratory, dermal) in the previous 30 days.
- •Right limb tremor or dyskinesia that cannot be comfortably controlled for 90 minutes.
结局指标
主要结局
NAD(H) metabolites
时间窗: baseline
Measurement of relative NAD(H) metabolite concentrations in resting skeletal muscle by magnetic resonance spectroscopy
ATPmax
时间窗: baseline
Maximal mitochondrial ATP production rates measured by magnetic resonance spectroscopy
Muscle force and endurance
时间窗: baseline
Maximum voluntary contraction (MVC) force in Newtons and fatigue resistance assessed by the ability to maintain repeated contractions at 70% MVC will be measured in the hand (flexor digitorum interroseus) and leg (tibialis anterior) using isometric contractions in a custom made apparatus.
次要结局
- Relationship between clinical assessment and mitochondrial energetics(baseline)
- Relationship between self report function and mitochondrial energetics(baseline)
- Mitochondrial metabolites(baseline)
研究者
David Marcinek
Professor of Radiology Research
University of Washington