Feasibility and Efficacy of the Ketogenic Diet in Alzheimer's Disease

Study Overview
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Brief Summary
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The purpose of the KDRAFT study is to assess the feasibility and preliminary cognitive efficacy of a ketogenic diet therapy in patients with Alzheimer's disease.

Official Title
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Alzheimer's Disease Ketogenic Diet Retention and Feasibility Trial

Conditions
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Alzheimer Disease

Intervention / Treatment
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* Behavioral: Ketogenic Diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Alzheimer's disease (CDR 0.5, 1, & 2) Active study partner BMI > 21 English speaking Exclusion Criteria: BMI < 21 Consume greater than 14 drinks of alcohol per week Insulin Dependent Diabetes Mellitus Diagnosis of active cancer Myocardial infarction or symptoms of coronary artery disease (e.g. angina) in last year
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ketogenic Diet Arm<br>All participants will be assigned to the 3-month ketogenic diet intervention. Study partners will be instructed to assist participants in adherence to a 1:1 ketogenic diet (approximately 70% fat, <10% carbohydrate, and 20% protein). Participants will be provided medium chain triglyceride oil 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. | Behavioral: Ketogenic Diet<br>* All participants will be assigned to the 3-month 1:1 ketogenic diet intervention (approximately 70% fat, <10% carbohydrate, and 20% protein).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of days positive for urinary ketone production | Participants will measure and report daily urinary ketone status using Ketostix (Bayer, Germany). | Daily for 90 days (the length of the diet intervention) | 
| Change in blood ketone levels induced by ketogenic diet | Serum beta-hydroxybutyrate levels will be measured at five monthly study visits; baseline prior to diet initiation, three monthly collections during the ketogenic diet intervention, and after the 1-month washout return to a regular diet. | Change from baseline serum beta-hydroxybutyrate levels at month 1, 2, 3 (end of ketogenic diet), and 4 (after 1-month washout). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cognitive performance on the Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-Cog) | Global cognitive performance will be assessed by a psychometrician using the Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-Cog). 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 from baseline global cognitive scores at month 3 (end of ketogenic diet) and change from month 3 global cognitive scores at month 4 (end of 1-month washout). | 
| Change in cognitive performance on the Mini-Mental State Exam (MMSE) | 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 from baseline global cognitive scores at month 3 (end of ketogenic diet) and change from month 3 global cognitive scores at month 4 (end of 1-month washout). | 
| Dietary intake characterization prior to and after ketogenic diet initiation | Changes in food and nutrient intake will be assessed by monthly 3-day food records completed by participant study partners. | Dietary intake will be collected at Baseline, Month 1, Month 2, Month 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ketogenic Diet, Alzheimer's disease