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

Alzheimer's Disease Ketogenic Diet Retention and Feasibility Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03690193

Acronym

KDRAFT

Enrollment

Registered

2018-10-01

Start date

2013-12-03

Completion date

2017-01-06

Last updated

2018-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease

Keywords

Ketogenic Diet, Alzheimer's disease

Brief summary

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.

Interventions

BEHAVIORALKetogenic Diet

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Proportion of days positive for urinary ketone production	Daily for 90 days (the length of the diet intervention)	Participants will measure and report daily urinary ketone status using Ketostix (Bayer, Germany).
Change in blood ketone levels induced by ketogenic diet	Change from baseline serum beta-hydroxybutyrate levels at month 1, 2, 3 (end of ketogenic diet), and 4 (after 1-month washout).	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.

Secondary

Measure	Time frame	Description
Change in cognitive performance on the Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-Cog)	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).	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 in cognitive performance on the Mini-Mental State Exam (MMSE)	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).	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.
Dietary intake characterization prior to and after ketogenic diet initiation	Dietary intake will be collected at Baseline, Month 1, Month 2, Month 3	Changes in food and nutrient intake will be assessed by monthly 3-day food records completed by participant study partners.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026