Therapeutic Diets in Alzheimer's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Change in cognitive performance on the Mini-Mental State Exam (MMSE)
研究概览
简要总结
By doing this study, researchers hope to learn how the ketogenic and Therapeutic Lifestyles Changes diets affect cognition in patients with Alzheimer's disease.
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
- Single (Outcomes Assessor)
盲法说明
All outcomes assessors are masked from participant group assignment.
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 AD by current McKhann et al. criteria
- •CDR global score of 0.5 or 1
- •Agreed cooperation from an appropriate study partner
- •Speaks English as primary language
- •Age 50 to 90
- •No medication changes within the past 30 days
排除标准
- •Resides in a nursing home or dementia special care unit, or cannot control diet
- •A potentially confounding serious medical risk including insulin-requiring diabetes, cancer requiring chemotherapy or radiation within the past 5 years, or a recent cardiac event (i.e. heart attack, angioplasty, etc.)
- •Participating in another clinical trial or using an investigational drug or therapy within 30 days of the Screening Visit
- •A history of renal stones
研究组 & 干预措施
Ketogenic Diet
Study partners will be instructed to assist participants in adherence to a 1:1 ketogenic diet (approximately 70% fat, <10% carbohydrate, and 20% protein as energy). The diet will encourage ≥4 servings of non-starchy vegetables and 1/2 cup of berries daily. Participants will be provided an emulsified medium chain triglyceride supplement with a target intake of 1-2 tablespoons per day and micronutrient supplements consisting of multivitamin, vitamin D, calcium, and phosphorus. After the 3-month ketogenic diet, participants will complete a 1-month washout period in which they halt adherence to the ketogenic diet and resume their normal diet.
干预措施: Ketogenic Diet (Behavioral)
Therapeutic Lifestyles Changes Diet
Study partners will be instructed to assist participants in adherence to the Therapeutic Lifestyles Changes diet. The diet consists of 20-35% fat, 50-60% carbohydrate, and ~15% protein as energy. Fat intake will comprise <7% saturated fat, ≤20% monounsaturated fat, and ≤10% polyunsaturated fat as total energy. Cholesterol consumption will be ≤200mg per day. Participants are encouraged to eat ≥2 servings of fruit and ≥5 servings of vegetables per day.
干预措施: Therapeutic Lifestyles Changes Diet (Behavioral)
结局指标
主要结局
Change in cognitive performance on the Mini-Mental State Exam (MMSE)
时间窗: Baseline, 12 Weeks
Global cognitive performance will be assessed by a psychometrician using the Mini-Mental State Exam (MMSE). The MMSE is a brief cognitive questionnaire with a maximum score of 30 points where higher scores indicate better cognitive performance.
Change in cognitive performance on the Logical Memory Test (LMT)
时间窗: Baseline, 12 Weeks
The Logical Memory, subtest of the WMS-R is a standardized assessment of narrative episodic memory. A short story is orally presented, and the examinee is asked to recall the story immediately.
Change in cognitive performance by Stroop test
时间窗: Baseline, 12 Weeks
Reaction time and accuracy will be assessed by a psychometrician using the Stroop test.
Change in cognitive performance on the Alzheimer's Disease Assessment Scale Cognitive Subscale (ADASCog11)
时间窗: Baseline, 12 Weeks
Cognitive performance will be assessed by a psychometrician using the Alzheimer's Disease Assessment Scale Cognitive Subscale (ADASCog11). The ADAS-Cog is an Alzheimer's disease specific, multi-domain cognitive assessment scored from 0-70 points with higher scores indicating poorer cognitive performance.
Change in Clinical Dementia Rating (CDR)
时间窗: Baseline, 12 Weeks
The Clinical Dementia Rating is a 5-point scale (CDR 0, 0.5, 1, 2, and 3) used to characterize six domains of cognitive and functional performance applicable to Alzheimer disease and related dementias. CDR 0 indicates no dementia and higher values indicate more severe dementia. The scores of all six domains are averaged to form a global CDR score. Change in score from baseline to 3 months will be assessed.
Change in Cognitive Performance on the Alzheimer's Disease Assessment Scale Cognitive Subscale (ADASCog11)
时间窗: Baseline, 12 Weeks
Cognitive performance will be assessed by a psychometrician using the Alzheimer's Disease Assessment Scale Cognitive Subscale (ADASCog11). The ADAS-Cog is an Alzheimer's disease specific, multi-domain cognitive assessment scored from 0-70 points with higher scores indicating poorer cognitive performance.
次要结局
- Change in self-reported symptoms by study partner(Baseline, 6 Weeks, 12 Weeks)
- Change in cerebral concentration of N-Acetylaspartate (NAA)(Baseline, 12 Weeks)
- Change in blood platelet mitochondrial function(Baseline, 6 Weeks, 12 Weeks)
- Change in Cognitive Performance on the Mini-Mental State Exam (MMSE)(Baseline, 12 Weeks)
- Change in Cognitive Performance on the Logical Memory Test 1 (LMT1)(Baseline, 12 Weeks)
- Change in Cognitive Performance on the Logical Memory Test 2 (LMT2)(Baseline, 12 weeks)
- Change in Cognitive Performance on the Stroop Word Test(Baseline, 12 Weeks)
- Change in Cognitive Performance on the Stroop Color Test(Baseline, 12 weeks)
- Change in Cognitive Performance on the Stroop Color-Word Test(Baseline, 12 weeks)
- Change in Clinical Dementia Rating (CDR)(Baseline, 12 Weeks)
- Change in Frontal Lobe Concentration of N-Acetylaspartate (NAA)(Baseline, 12 Weeks)
- Change in Frontal Lobe Concentration of Glutamate Plus Glutamine (Glx)(Baseline, 12 weeks)
- Change in Blood Platelet COX/CS Vmax(Baseline, 6 Weeks, 12 Weeks)
研究者
Russell Swerdlow
Professor
University of Kansas Medical Center