Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2026-03-26 @ 10:13 PM
Study NCT ID:
NCT04466735
Status:
COMPLETED
Last Update Posted:
2025-06-03
First Post:
2020-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BRain Energy Activation With Ketones to Prevent Alzheimer's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Investigators, participants and outcome assessors will be fully blinded.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial. First phase :Two parallel groups, one placebo, one active Second phase : All participants will be invited to take part in an open phase on the active product only.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-03-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-28', 'studyFirstSubmitDate': '2020-07-07', 'studyFirstSubmitQcDate': '2020-07-09', 'lastUpdatePostDateStruct': {'date': '2025-06-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acetoacetate brain uptake', 'timeFrame': '6 months', 'description': 'CMRacac measured by PET Scan'}, {'measure': 'Glucose brain uptake', 'timeFrame': '6 months', 'description': 'CMRgluc measured by PET Scan'}], 'secondaryOutcomes': [{'measure': 'Cognition', 'timeFrame': '0-3-6-9 months'}, {'measure': 'Plasma biomarkers', 'timeFrame': '9 months', 'description': 'glucose, fatty acids, ketones'}, {'measure': 'Structural and functional brain measures', 'timeFrame': '6 months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['MCI']}, 'descriptionModule': {'briefSummary': 'A six month randomized controlled intervention with an exogenous ketone salt (EKS) supplement in mild cognitive impairment. Participants will receive 15 g of the supplement twice daily (equivalent to 24 g/day of EKS). Outcomes: brain energy metabolism, cognition, plasma biomarkers, brain imaging (volumetric, functional, structural) and quality of life will be analyzed before and after the intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '55 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The participant must answer Yes to the question ''Do you think your memory is not as good as it was?''\n* Have a MoCA Score between 20/30 and 26/30\n* Have a QAF score of less than 9/30\n* Understand, read and talk French\n* Having good visual and hearing acuity\n\nExclusion Criteria:\n\n* Major cognitive decline or neurodegenerative disease.\n* Already consuming a daily medium chain triglyceride or ketone supplement.\n* Soy, milk, gluten or allergy to the study product\n* Controlled or uncontrolled diabetes\n* Uncontrolled chronic disease\n* Vitamin B12 deficit\n* Clinical anomaly in the blood chemistry profile\n* QSP-9 score over 19/27\n* Taking an anti-cholinergic drugs\n* Recent change in medication\n* Active cancer in the last 2 years\n* General anesthesia in the last 6 months\n* history of alcohol abuse or dependence in the last 2 years\n* Participation in other interventional or PET research project\n* Unable to undergo an MRI or PET scan\n* History of kidney stones or hypercalcemia\n* History of cardiovascular events or insufficiency\n* Renal failure and / or creatinine \\<58 umol or\\> 110 umol for men and \\<46 umol or\\> 92 umol for women or if the GFR (glomerular filtration rate) \\<60 ml / min / 1.73 m2\n* Chronic disease of the digestive system or intestinal malabsorption (celiac disease, chronic pancreatitis, Crohn's disease, etc.)\n* Body mass index \\<20 or voluntary weight loss of more than 5% in the last 6 months."}, 'identificationModule': {'nctId': 'NCT04466735', 'acronym': 'BREAK-AD', 'briefTitle': "BRain Energy Activation With Ketones to Prevent Alzheimer's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Université de Sherbrooke'}, 'officialTitle': '6 Month Randomized Controlled Trial With D-beta-hydroxybutyrate in Mild Cognitive Impairment', 'orgStudyIdInfo': {'id': '2020-3448'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active group', 'description': 'Participants will be on the active intervention for 6 months', 'interventionNames': ['Dietary Supplement: Active group']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Group', 'description': 'Participants will be on the placebo intervention for 6 months', 'interventionNames': ['Dietary Supplement: Placebo group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Open phase on active product', 'description': 'At the end of the 6-month randomized controlled phase, participants will be unblinded and invited to continue on the active product for an additional 3 months.', 'interventionNames': ['Dietary Supplement: Active group']}], 'interventions': [{'name': 'Active group', 'type': 'DIETARY_SUPPLEMENT', 'description': '2 x 12 g of EKS/day', 'armGroupLabels': ['Active group', 'Open phase on active product']}, {'name': 'Placebo group', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Isocaloric placebo supplement with similar salt load but no EKS', 'armGroupLabels': ['Placebo Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'J1H4C4', 'city': 'Sherbrooke', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Rearsh Centre on Aging', 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Université de Sherbrooke', 'class': 'OTHER'}, 'collaborators': [{'name': "Alzheimer's Association", 'class': 'OTHER'}, {'name': 'Nestle Health Science', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}