Alzheimer Disease and Related Dementias (ADRD)NCT06767124
Veech Ketone Ester to Support Brain Energy in Mild Cognitive Impairment and Early Alzheimer's Disease
A study testing Ketogenic Supplement in people with Alzheimer Disease and Related Dementias (ADRD), run by University of Pennsylvania at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Alzheimer Disease and Related Dementias (ADRD)
- What is being tested?
- Ketogenic Supplement
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2026to May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria - 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
Exclusion Criteria: Contraindications to MRI (claustrophobia, metal implants, pacemakers, etc.), Pregnant or breastfeeding women, Neurological disease (healthy participants only), Mental illness, Overt cardio- or neurovascular disease, Recent participation in any procedure(s) involving radioactive agents
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Lawson Research Institute
London, Ontario, N6A 4BQ
Keith St Lawrence, PhD, (519) 646-6100 ext. 65737, kstlawr@uwo.ca
Keith St Lawrence, PhD
About this study
Official title: Simultaneous PET/MR Imaging of Brain Glucose and Oxygen Metabolism to Assess Energy Deficits Related to Alzheimer's Disease and the Response to Intervention
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.
Read the detailed description
There are now close to six million people in the Unites States living with dementia and this number is only expected to grow as the population continues to age. The current lack of effective treatments for Alzheimer's disease (AD) speaks to the need to better understand the multiple factors that contribute to this complex disease. There is growing evidence that age-related metabolic dysfunction in the brain plays a role in the disease's etiology. This concept has led to treatments aimed at improving brain energy production. Notably, ketogenic dietary supplements have been shown to increase brain ketone metabolism and improve cognitive performance in AD patients. However, the overall benefits to brain metabolism in the AD brain are unknown given the complexity of imaging both oxygen and glucose metabolism in a single session by positron emission tomography (PET). Taking advantage of hybrid PET/MR imaging, this study will combine PET and MRI methods to investigate the effects of a ketogenic supplement on brain oxygen and glucose metabolism in AD patients.
- Being tested
- Ketogenic Supplement, Placebo Drink
- Keywords
- PET/MR, Ketone Supplement, Brain Energy Metabolism
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketogenic SupplementDietary supplement
Also called KetoneAid, Veech Ketone Monoester
D-Beta-Hydroxybutyrate bonded to R-1,3 Butanediol
Placebo DrinkOther
Placebo drink containing flavored water.
| Study group | Role | What they receive |
|---|---|---|
| Alzheimer's Disease Patients - Treatment | Active comparator | Patients 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. Receives: Dietary Supplement: Ketogenic Supplement |
| Alzheimer's Disease Patients - Placebo | Placebo comparator | Patients 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. Receives: Other: Placebo Drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline and 7 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start1 Sep 2026 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alzheimer Disease and Related Dementias (ADRD)Studies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Each patient receives a placebo and the active treatment on separate occasions undergoing the same imaging protocol.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 17 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), University of Western Ontario, Canada
- Responsible party
- Sponsor
- Investigators
- Keith St Lawrence, PhD, Principal investigator, Lawson Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06767124
- Sponsor's protocol ID
- 126350
- Other IDs
- 1R01NS131235-01A1
- Status last verified
- Aug 2026
- First submitted
- 6 Jan 2025
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 40921289Panse 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.
PubMed 40087222
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simultaneous PET/MR Imaging of Brain Glucose and Oxygen Metabolism to Assess Energy Deficits Related to Alzheimer's Disease and the Response to Intervention
- ClinicalTrials.gov ID
- NCT06767124
- Acronym / sponsor ID
- 126350
- Keywords
- PET/MR, Ketone Supplement, Brain Energy Metabolism
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 17 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), University of Western Ontario, Canada
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 9 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
There are now close to six million people in the Unites States living with dementia and this number is only expected to grow as the population continues to age. The current lack of effective treatments for Alzheimer's disease (AD) speaks to the need to better understand the multiple factors that contribute to this complex disease. There is growing evidence that age-related metabolic dysfunction in the brain plays a role in the disease's etiology. This concept has led to treatments aimed at improving brain energy production. Notably, ketogenic dietary supplements have been shown to increase brain ketone metabolism and improve cognitive performance in AD patients. However, the overall benefits to brain metabolism in the AD brain are unknown given the complexity of imaging both oxygen and glucose metabolism in a single session by positron emission tomography (PET). Taking advantage of hybrid PET/MR imaging, this study will combine PET and MRI methods to investigate the effects of a ketogenic supplement on brain oxygen and glucose metabolism in AD patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Each patient receives a placebo and the active treatment on separate occasions undergoing the same imaging protocol.
| Arm | Type | Receives |
|---|---|---|
| Alzheimer's Disease Patients - Treatment | Active comparator | Dietary Supplement: Ketogenic SupplementPatients 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 comparator | Other: Placebo DrinkPatients 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketogenic SupplementAlso: KetoneAid, Veech Ketone MonoesterD-Beta-Hydroxybutyrate bonded to R-1,3 Butanediol | Dietary supplement | Alzheimer's Disease Patients - Treatment |
| Placebo DrinkPlacebo drink containing flavored water. | Other | Alzheimer's Disease Patients - Placebo |
Primary outcome
Cerebral Metabolic Rate of Oxygen (CMRO2)
Time frame: CMRO2 will be measured in both imaging sessions (placebo and ketosis)
Statistical analysis of imaging data sets under placebo and ketosis conditions will be used to investigate increases in regional CMRO2 caused by ketosis.
Cerebral Metabolic Rate of Glucose (CMRGlu)
Time frame: CMRGlu will be measured in both imaging session (placebo and ketosis)
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.
1 secondary outcome
Cognitive Function
Time frame: Baseline and 7 Days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Background: PubMed 40921289Panse 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.
- Background: PubMed 40087222Panse 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Keith St Lawrence, PhD principal investigator
Lawson Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketogenic Supplement in people with Alzheimer Disease and Related Dementias (ADRD), run by University of Pennsylvania at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Keith St Lawrence, PhD ((519) 646-6100 ext. 65737, kstlawr@uwo.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebral Metabolic Rate of Oxygen (CMRO2) (time frame: CMRO2 will be measured in both imaging sessions (placebo and ketosis)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06767124, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026; AzTrials last refreshed its copy on 6 Nov 2026.