A Medium Chain Triglyceride INTervention for Alzheimer Disease (A MINT for AD)
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Number of participants with adverse events, serious adverse events
研究概览
简要总结
The purpose of this study is to determine safety, tolerability, and pharmacokinetics/dynamics of a ketogenic dietary supplement containing medium chain triglycerides (MCTs) in patients with Alzheimer disease (AD). Novel imaging and laboratory biomarkers in response to this intervention will also be explored.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of mild-moderate Alzheimer disease (AD)
- •Mini-Mental State Examination (MMSE) 16-26
- •Study partner available who has frequent contact with the participant
- •Good visual and auditory acuity for neuropsychological testing
- •Education including completion of at least six grades
- •Must read and speak English fluently
- •Antidepressants permitted, if stable for 4 weeks prior to screening (and participant is not currently depressed and does not have a history of major depression within the past 1 year)
- •Cholinesterase inhibitors permitted, if stable for 12 weeks prior to screening
排除标准
- •Any significant neurologic disease other than AD
- •History of Diabetes Mellitus type I or II
- •Any contraindications to MRI or PET studies
- •Major depression, bipolar disorder as described within the past 1 year.
- •History of schizophrenia
- •History of alcohol or substance abuse or dependence within the past 2 years
- •Any significant systemic illness or unstable medical condition, which could lead to difficulty complying with the protocol
- •Current use of specific psychoactive medications
- •Investigational amyloid lowering therapies are prohibited two months prior to screening and for the duration of the trial. Other investigational agents are prohibited one month prior to screening and for the duration of the trial.
- •History of brain cancer
研究组 & 干预措施
Ketogenic medium chain triglyceride drink
Lactose-free skim milk drink containing 25 g of MCT oil per 250 ml.
干预措施: Ketogenic medium chain triglyceride drink (MCT drink) (Dietary Supplement)
Placebo
Lactose-free skim milk drink containing high-oleic sunflower oil in the equivalent amount of energy as the active arm.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Number of participants with adverse events, serious adverse events
时间窗: From baseline to day 10 of intervention
Plasma ketone concentrations in response to ascending dose of MCT
时间窗: Day 10 of intervention at 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, and 6 hours post MCT dose
Plasma ketone concentrations of betahydroxybutyrate (BHB) and acetoacetate (AcAc) will be measured in response to MCT dosing from 10-50 grams daily.
次要结局
- Area under the plasma concentration versus time curve (AUC) of MCT(Day 10 of intervention at 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, and 6 hours post MCT dose)
研究者
Haakon Nygaard
Principal Investigator
University of British Columbia