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

University of Kansas Medical Center15 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Alzheimer Disease

Interventions

Ketogenic DietBEHAVIORAL

All participants will be assigned to the 3-month 1:1 ketogenic diet intervention (approximately 70% fat, \<10% carbohydrate, and 20% protein).

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Proportion of days positive for urinary ketone production

Participants will measure and report daily urinary ketone status using Ketostix (Bayer, Germany).

Time frame: 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.

Time frame: Change from baseline serum beta-hydroxybutyrate levels at month 1, 2, 3 (end of ketogenic diet), and 4 (after 1-month washout).

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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

Data from ClinicalTrials.gov

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