Veech Ketone Ester to Support Brain Energy in Mild Cognitive Impairment and Early Alzheimer's Disease
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorUniversity of Pennsylvania
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Alzheimer's Disease Participants: Positive amyloid and tau biomarkers (as noted by PET imaging, cerebrospinal fluid or blood), Mild cognitive impairment or mild-to-moderate dementia, BMI of 18.5-30
Disqualifiers
None
Trial design
Design model
Crossover
Treatments tested in this trial
Ketogenic Supplement
Dietary supplementD-Beta-Hydroxybutyrate bonded to R-1,3 Butanediol
Placebo Drink
Other interventionPlacebo drink containing flavored water.
Treatment groups
17 Participants
are divided into 2 treatment groupsGroup A: Alzheimer's Disease Patients - TreatmentActive comparator 1 intervention
Group B: Alzheimer's Disease Patients - PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
CMRO2 will be measured in both imaging sessions (placebo and ketosis)2
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.
Time frame
CMRGlu will be measured in both imaging session (placebo and ketosis)Secondary outcomes
1
Cognitive Function
A psychometrist will assess baseline cognition using the Mini-Mental State Examination, the Montreal Cognitive Assessment, and the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog). The ADAS-cog will be repeated at the end of the second imaging session to test the potential cognitive benefits of the ketogenic supplement.
Time frame
Baseline and 7 DaysSponsors and contacts
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University of Pennsylvania
Lead sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
University of Western Ontario, Canada
Collaborator
Source ClinicalTrials.gov
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