Veech Ketone Ester to Support Brain Energy in Mild Cognitive Impairment and Early Alzheimer's Disease
Simultaneous PET/MR Imaging of Brain Glucose and Oxygen Metabolism to Assess Energy Deficits Related to Alzheimer's Disease and the Response to Intervention
2 other identifiers
interventional
17
1 country
1
Brief Summary
It is projected that by 2030, one in every five Americans will be of retirement age, and this demographic shift is expected to result in more people suffering from dementia. A key feature of the brain is its need for a constant supply of glucose and oxygen to meet the high energy costs of mental activity. This study aims to develop clinically practical, noninvasive imaging methods based on combined positron emission tomography and magnetic resonance imaging to assess brain energy in order to better understand how this critical component of brain health is impacted by aging.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 6, 2025
CompletedFirst Posted
Study publicly available on registry
January 9, 2025
CompletedStudy Start
First participant enrolled
September 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2028
August 26, 2026
August 1, 2026
1.5 years
January 6, 2025
August 25, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Cerebral Metabolic Rate of Oxygen (CMRO2)
Statistical analysis of imaging data sets under placebo and ketosis conditions will be used to investigate increases in regional CMRO2 caused by ketosis.
CMRO2 will be measured in both imaging sessions (placebo and ketosis)
Cerebral Metabolic Rate of Glucose (CMRGlu)
Statistical analysis of imaging data sets under placebo and ketosis conditions will be used to investigate changes in regional CMRGlu caused by ketosis. Unlike CMRO2, no difference in CMRGlu is expected between the two conditions for Alzheimer's patients.
CMRGlu will be measured in both imaging session (placebo and ketosis)
Secondary Outcomes (1)
Cognitive Function
Baseline and 7 Days
Study Arms (2)
Alzheimer's Disease Patients - Treatment
ACTIVE COMPARATORPatients within the Alzheimer's continuum will be selected based on the National Institute of Aging - Alzheimer's Association Diagnostic Framework and be either classified as having mild cognitive impairment or mild-to-moderate dementia. Participants will undergo two PET/MR sessions in which CMRGlu and CMRO2 will be imaged simultaneously by PET and qBOLD MRI. For validation, CMRO2 will also be imaged by PMROx prior to FDG injection. The study will follow a crossover design in which participants will receive a ketogenic supplement prior to imaging.
Alzheimer's Disease Patients - Placebo
PLACEBO COMPARATORPatients within the Alzheimer's continuum will be selected based on the National Institute of Aging - Alzheimer's Association Diagnostic Framework and be either classified as having mild cognitive impairment or mild-to-moderate dementia. Participants will undergo two PET/MR sessions in which CMRGlu and CMRO2 will be imaged simultaneously by PET and qBOLD MRI. For validation, CMRO2 will also be imaged by PMROx prior to FDG injection. The study will follow a crossover design in which participants will receive a placebo drink prior to imaging.
Interventions
D-Beta-Hydroxybutyrate bonded to R-1,3 Butanediol
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Lawson Research Institute
London, Ontario, N6A 4BQ, Canada
Related Publications (2)
Panse N, Lafrenaye A, Bergman C, Gerk PM. In vivo pharmacokinetic evaluation of Veech ketone monoester and metabolites in rats after IV (bolus and infusion) and oral administration. Int J Pharm. 2025 Nov 10;684:126130. doi: 10.1016/j.ijpharm.2025.126130. Epub 2025 Sep 6.
PMID: 40921289BACKGROUNDPanse N, Gerk PM. Characterizing the Hepatic Metabolic Pathway of Ketone Ester and Subsequent Metabolites Using Human and Rat Liver Fractions. AAPS J. 2025 Mar 14;27(2):65. doi: 10.1208/s12248-025-01044-7.
PMID: 40087222BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Keith St Lawrence, PhD
Lawson Research Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Participants will not know if they have consumed the ketone monoester supplement drink or a placebo drink.
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 6, 2025
First Posted
January 9, 2025
Study Start
September 1, 2026
Primary Completion (Estimated)
March 1, 2028
Study Completion (Estimated)
May 1, 2028
Last Updated
August 26, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data release will follow a 36-month optional embargo to allow time for publication in a peer-reviewed journal.
- Access Criteria
- Data submitted to OpenNeuro are first associated with metadata from the BIDS dataset and with submitter-provided metadata, then indexed for searching. Copies of absorbed content -- from each submitted dataset version -- are subsequently assigned persistent digital object identifiers (DOIs). Datasets will be made publicly available through OpenNeuro with nominal restrictions using multiple open protocols. Prior to being made public, access to a dataset is controlled through strict authentication policies and an isolated storage backend to further guard against unintended access.
Data sets to be shared include imaging data and participant demographics. Data will be made publicly available through the data sharing and archiving platform OpenNeuro.