Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2026-02-22 @ 6:46 PM
Study NCT ID:
NCT03690193
Status:
COMPLETED
Last Update Posted:
2018-10-01
First Post:
2018-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility and Efficacy of the Ketogenic Diet in Alzheimer's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055423', 'term': 'Diet, Ketogenic'}], 'ancestors': [{'id': 'D050528', 'term': 'Diet, Carbohydrate-Restricted'}, {'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2017-01-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-27', 'studyFirstSubmitDate': '2018-08-01', 'studyFirstSubmitQcDate': '2018-09-27', 'lastUpdatePostDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-01-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of days positive for urinary ketone production', 'timeFrame': 'Daily for 90 days (the length of the diet intervention)', 'description': 'Participants will measure and report daily urinary ketone status using Ketostix (Bayer, Germany).'}, {'measure': 'Change in blood ketone levels induced by ketogenic diet', 'timeFrame': 'Change from baseline serum beta-hydroxybutyrate levels at month 1, 2, 3 (end of ketogenic diet), and 4 (after 1-month washout).', 'description': '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.'}], 'secondaryOutcomes': [{'measure': "Change in cognitive performance on the Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-Cog)", 'timeFrame': '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).', 'description': "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."}, {'measure': 'Change in cognitive performance on the Mini-Mental State Exam (MMSE)', 'timeFrame': '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).', 'description': '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.'}, {'measure': 'Dietary intake characterization prior to and after ketogenic diet initiation', 'timeFrame': 'Dietary intake will be collected at Baseline, Month 1, Month 2, Month 3', 'description': 'Changes in food and nutrient intake will be assessed by monthly 3-day food records completed by participant study partners.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ketogenic Diet', "Alzheimer's disease"], 'conditions': ['Alzheimer Disease']}, 'referencesModule': {'references': [{'pmid': '30931426', 'type': 'DERIVED', 'citation': 'Taylor MK, Swerdlow RH, Burns JM, Sullivan DK. An Experimental Ketogenic Diet for Alzheimer Disease Was Nutritionally Dense and Rich in Vegetables and Avocado. Curr Dev Nutr. 2019 Feb 20;3(4):nzz003. doi: 10.1093/cdn/nzz003. eCollection 2019 Apr.'}]}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Alzheimer's disease (CDR 0.5, 1, \\& 2)\n* Active study partner\n* BMI \\> 21\n* English speaking\n\nExclusion Criteria:\n\n* BMI \\< 21\n* Consume greater than 14 drinks of alcohol per week\n* Insulin Dependent Diabetes Mellitus\n* Diagnosis of active cancer\n* Myocardial infarction or symptoms of coronary artery disease (e.g. angina) in last year"}, 'identificationModule': {'nctId': 'NCT03690193', 'acronym': 'KDRAFT', 'briefTitle': "Feasibility and Efficacy of the Ketogenic Diet in Alzheimer's Disease", 'organization': {'class': 'OTHER', 'fullName': 'University of Kansas Medical Center'}, 'officialTitle': "Alzheimer's Disease Ketogenic Diet Retention and Feasibility Trial", 'orgStudyIdInfo': {'id': '13796'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ketogenic Diet Arm', 'description': '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.', 'interventionNames': ['Behavioral: Ketogenic Diet']}], 'interventions': [{'name': 'Ketogenic Diet', 'type': 'BEHAVIORAL', 'description': 'All participants will be assigned to the 3-month 1:1 ketogenic diet intervention (approximately 70% fat, \\<10% carbohydrate, and 20% protein).', 'armGroupLabels': ['Ketogenic Diet Arm']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Kansas Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Debra K Sullivan, PhD, RD, Chair and Endowed Professor of Clinical Nutrition', 'investigatorFullName': 'Debra K. Sullivan, PhD, RD', 'investigatorAffiliation': 'University of Kansas Medical Center'}}}}