Effects of NAD Restoration on Neurovascular Coupling in Community Dwelling Older Adults
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 214
- 试验地点
- 1
- 主要终点
- Change in neurovascular coupling using functional near infrared spectroscopy (fNIRS)
研究概览
简要总结
Daily consumption of one of the forms of Vitamin B3, the Nicotinamide Riboside (NR), energizes the body and combats cellular aging. This study is designed to test whether NR can also improve brain health and memory.
详细描述
This study is designed to test the hypothesis that restoration of Nicotinamide Adenine Dinucleotide (NAD) levels with Nicotinamide Riboside (NR) in older adults will improve neurovascular coupling (NVC) responses and micro- and macrovascular endothelial function. This hypothesis will be tested by assessing the effects of treatment with oral NR (1g/day per os for 8 weeks) or placebo (8 weeks) in community dwelling older adults (60-85 years of age).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
All data will be unmasked upon completion of the trial, or during performance of data review if requested by the data safety and monitoring board.
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥60 and ≤85 years of age
- •Adequate hearing and visual acuity to participate in the examinations
- •Ability to read and write in English
- •Competence to provide informed consent.
- •Mini-Mental State Exam score ≥24
排除标准
- •Vision or hearing impairment that would impair the ability to complete study assessments
- •Active CNS disease including multiple sclerosis, uncontrolled seizures, active brain cancer
- •Cerebrovascular accident other than TIA within 60 days prior to Visit 0
- •Major psychiatric disease, including major depression not currently controlled on medications, alcohol or drug abuse
- •Abnormal kidney function (creatinine >2mg/dL or EGFR <30mL/min) by most recent labs within 6 months prior to Visit 0
- •Elevated liver enzymes (AST and/or ALT above x2 upper limit of normal) by most recent labs within 6 months prior to Visit 0
- •Treatment with other NAD enhancers (Nicotinamide riboside or nicotinamide mononucleotide) within 4 weeks prior to randomization.
- •Any other medical condition which, in the opinion of investigator, would render the patient inappropriate or too unstable to complete the study protocol
研究组 & 干预措施
NR
Treatment with oral NR (1g/day per os for 8 weeks)
干预措施: Nicotinamide riboside (Drug)
Control
Visually identical placebo (daily, per os, for 8 weeks)
干预措施: Placebo (Drug)
结局指标
主要结局
Change in neurovascular coupling using functional near infrared spectroscopy (fNIRS)
时间窗: 8 weeks
Functional near infrared spectroscopy (fNIRS) will be performed during the cognitive n-back task. fNIRS approach generates data that represent a relative change in oxygenated and deoxygenated hemoglobin measured over the cortical brain tissues. Neurovascular coupling will be evaluated as a change in oxy- and deoxy-hemoglobin between before and after treatment. Units of measure - beta. Reported as a %change from baseline, before and after treatment.
Change in neurovascular coupling using transcranial Doppler
时间窗: 8 weeks
Transcranial Doppler sonography will be used to measure the change in the blood flow velocities during the cognitive n-back task between before and after treatment. Units of measure - % change between the n-back tasks. Reported as a %change from baseline, before and after treatment.
Change in neurovascular coupling using the dynamic retinal vessel analysis
时间窗: 8 weeks
Flicker light-induced dilation of the retinal vessels (percentage increase over baseline diameter) will be measured in the right or left eye of each study participant using the Dynamic Vessel Analyzer (DVA, IMEDOS Systems, Jena, Germany). Units of measure mm, reported as a %change from baseline, before and after treatment.
Change in neuronal activity
时间窗: 8 weeks
EEG signal will be collected to generate spectral data. These data will be used for comparison of EEG activity between before and after treatment. Units of measure - power spectral density. Reported as a %change from baseline, before and after treatment.
次要结局
- Change in microvascular endothelial function(8 weeks)
- Change in macrovascular endothelial function(8 weeks)
- Change in deep tissue oxygen saturation(8 weeks)
- Change in arterial stiffness(8 weeks)
- Change in ECG(8 weeks)
- Change in Glycocalyx - perfused boundary region(8 weeks)
- Change in capillary density(8 weeks)
- Change in red blood cell velocity(8 weeks)
- Change in Attention(8 weeks)
- Change in Episodic Memory(8 weeks)
- Change in Working Memory(8 weeks)
- Change in Language(8 weeks)
- Change in Executive Function(8 weeks)
- Change in Processing Speed(8 weeks)
- Blood collection(8 weeks)