Evaluating Cognitive and Functional Impairment in Alzheimer's Dementia With a Ketogenic Diet.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 主要终点
- Behavior
研究概览
简要总结
The present study is being done in a scientifically rigorous manner, using readily available MCT oil (refined from coconut oil) versus a placebo oil to assess any cognitive and functional benefits for AD patients.
详细描述
The proposed study, is a randomized placebo controlled cross-over study for 6 months, with an open label extension for another 6 months designed to test the benefits and safety of MCT oil in patients with established AD. It will be the first study on MCT oil ever done with this design, and for this duration in AD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double blind placebo controlled
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
- •Patients >49years with a clinical diagnosis of AD
- •Mini Mental Status Examination (MMSE) score 10-29/30
- •on stable dose of medications for 3 months (AChEI, memantine and antidepressants allowed)
- •able to speak English
- •patient or designate able to sign informed consent
- •stable chronic medical conditions (Heart disease, thyroid disease)
- •reliable caregiver
排除标准
- •age <50 years
- •medically unstable
- •unable to swallow liquids
- •diagnosis of diabetes mellitus
- •residence in a nursing/long term care home
- •allergy to coconut
- •allergy to olive oil
结局指标
主要结局
Behavior
时间窗: 15 months
Neuropsychiatric Inventory (NPI) 0-96 Higher score with more behaviour problems
cognition
时间窗: 15 months
Cognigram (Cogstate) 0-200. Higher score with higher cognitive function
Cognition
时间窗: 15 months
Montreal Cognitive Assessment (MoCA) 0-30. Higher score with higher cognition
Function
时间窗: 15 months
Katz Activities of Daily Living Scale 0-6 Higher score with poorer ADL function
次要结局
- maximum tolerated daily dose (ml) of placebo (olive) oil(4 months)
- Serum cholesterol mmol/l(15 months)
- maximum tolerated daily dose (ml) of MCT oil(11 months)
- Serum Low density lipoprotein (LDL) mmol/l(15 months)
- Dual Energy Absorptiometry (DXA) Body fat(15 months)
- Incidence of treatment-emergent Adverse events(15 months)
- Serum Triglyceride mmol/l(15 months)
研究者
Angela Juby
Professor of Medicine
University of Alberta