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Not yet recruitingNCT06767124ClinicalTrials.gov record

Veech Ketone Ester to Support Brain Energy in Mild Cognitive Impairment and Early Alzheimer's Disease

Alzheimer Disease and Related Dementias (ADRD)

THE QUICK READ

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type
Interventional
Phase
Not applicable
Age range
21 years - Not specified
Sex eligible
All sexes
Healthy volunteers
Not accepted
Participants
17 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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 full 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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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

Understand screening

Treatment, groups and participation

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Assignment
Random assignment
Masking
Single masked
Alzheimer's Disease Patients - Treatment

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.

Dietary Supplement: Ketogenic Supplement

Alzheimer's Disease Patients - Placebo

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.

Other: Placebo Drink

Ketogenic Supplement DIETARY_SUPPLEMENT

D-Beta-Hydroxybutyrate bonded to R-1,3 Butanediol

Placebo Drink OTHER

Placebo drink containing flavored water.

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

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.

Secondary measures

Cognitive Function

Time frame: Baseline and 7 Days

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.

No results are flagged as posted.

Review the complete result tables and limitations in the official record.

Open official results ↗

Research locations (1)

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1 locations

Lawson Research InstituteLondon, Ontario, CanadaStatus unknown
Keith St Lawrence, PhDCONTACTkstlawr@uwo.ca(519) 646-6100 65737
Keith St Lawrence, PhDPRINCIPAL_INVESTIGATOR
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Study team and timeline

Lead sponsor
University of Pennsylvania
Study start
Dec 1, 2026 Estimated
Primary completion
2028-03 Estimated
Study completion
2028-05 Estimated
First posted
Jan 9, 2025 Actual
Last updated
Nov 10, 2026 Actual

Official study contacts

Keith St Lawrence, PhDCONTACTkstlawr@uwo.ca(519) 646-6100 65737
Official study 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

A HUMAN NEXT STEP

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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.

Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026