Ignite Creation Date:
2025-12-24 @ 3:54 PM
Ignite Modification Date:
2026-01-06 @ 6:08 AM
Study NCT ID:
NCT03860792
Status:
COMPLETED
Last Update Posted:
2025-12-17
First Post:
2019-02-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Therapeutic Diets 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': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'All outcomes assessors are masked from participant group assignment.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 84}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-06-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-11', 'studyFirstSubmitDate': '2019-02-28', 'studyFirstSubmitQcDate': '2019-02-28', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in blood ketone levels induced by ketogenic diet', 'timeFrame': 'Baseline, 6 Weeks, 12 Weeks', 'description': 'We will measure serum beta-hydroxybutyrate levels.'}, {'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': 'Dietary intake characterization prior to and after ketogenic diet initiation', 'timeFrame': 'Baseline, 6 Weeks, 12 Weeks', 'description': 'Changes in food and nutrient intake will be assessed by monthly 3-day food records completed by participant study partners.'}], 'primaryOutcomes': [{'measure': "Change in cognitive performance on the Alzheimer's Disease Assessment Scale Cognitive Subscale (ADASCog11)", 'timeFrame': 'Baseline, 12 Weeks', 'description': "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."}, {'measure': 'Change in cognitive performance on the Mini-Mental State Exam (MMSE)', 'timeFrame': 'Baseline, 12 Weeks', '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': 'Change in cognitive performance on the Logical Memory Test (LMT)', 'timeFrame': 'Baseline, 12 Weeks', 'description': '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.'}, {'measure': 'Change in cognitive performance by Stroop test', 'timeFrame': 'Baseline, 12 Weeks', 'description': 'Reaction time and accuracy will be assessed by a psychometrician using the Stroop test.'}, {'measure': 'Change in Clinical Dementia Rating (CDR)', 'timeFrame': 'Baseline, 12 Weeks', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Change in cerebral concentration of N-Acetylaspartate (NAA)', 'timeFrame': 'Baseline, 12 Weeks', 'description': 'Concentration of cerebral N-Acetylaspartate is measured using magnetic resonance spectroscopy in a 3T clinical scanner.'}, {'measure': 'Change in blood platelet mitochondrial function', 'timeFrame': 'Baseline, 6 Weeks, 12 Weeks', 'description': 'Cytochrome c oxidase activity of blood platelets will be determined as a pseudo first order-rate constant (sec-1/mg protein) by measuring the oxidation of reduced cytochrome c at 550 nm.'}, {'measure': 'Change in self-reported symptoms by study partner', 'timeFrame': 'Baseline, 6 Weeks, 12 Weeks', 'description': 'Severity of symptoms will be measured via a self-reported symptoms questionnaire, answered by participant study partners.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alzheimer Disease']}, 'descriptionModule': {'briefSummary': "By doing this study, researchers hope to learn how the ketogenic and Therapeutic Lifestyles Changes diets affect cognition in patients with Alzheimer's disease."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of AD by current McKhann et al. criteria\n* CDR global score of 0.5 or 1\n* Agreed cooperation from an appropriate study partner\n* Speaks English as primary language\n* Age 50 to 90\n* No medication changes within the past 30 days\n\nExclusion Criteria:\n\n* Resides in a nursing home or dementia special care unit, or cannot control diet\n* 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.)\n* Participating in another clinical trial or using an investigational drug or therapy within 30 days of the Screening Visit\n* A history of renal stones'}, 'identificationModule': {'nctId': 'NCT03860792', 'acronym': 'TDAD', 'briefTitle': "Therapeutic Diets in Alzheimer's Disease", 'organization': {'class': 'OTHER', 'fullName': 'University of Kansas Medical Center'}, 'officialTitle': "Therapeutic Diets in Alzheimer's Disease", 'orgStudyIdInfo': {'id': 'STUDY00143457'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ketogenic Diet', 'description': '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.', 'interventionNames': ['Behavioral: Ketogenic Diet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Therapeutic Lifestyles Changes Diet', 'description': '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.', 'interventionNames': ['Behavioral: Therapeutic Lifestyles Changes Diet']}], 'interventions': [{'name': 'Ketogenic Diet', 'type': 'BEHAVIORAL', 'description': 'Three-month 1:1 ketogenic diet intervention (approximately 70% fat, \\<10% carbohydrate, and 20% protein).', 'armGroupLabels': ['Ketogenic Diet']}, {'name': 'Therapeutic Lifestyles Changes Diet', 'type': 'BEHAVIORAL', 'description': 'Three-month diet intervention that is low in fat and cholesterol, high in fruits, vegetables, and whole grains, and moderate in protein.', 'armGroupLabels': ['Therapeutic Lifestyles Changes Diet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66205', 'city': 'Fairway', 'state': 'Kansas', 'country': 'United States', 'facility': 'Clinical and Translational Science Unit', 'geoPoint': {'lat': 39.02223, 'lon': -94.6319}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Kansas Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Russell Swerdlow', 'investigatorAffiliation': 'University of Kansas Medical Center'}}}}