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

August 25, 2026 updated by: University of Pennsylvania

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Keith St Lawrence, PhD
  • Phone Number: 65737 (519) 646-6100
  • Email: kstlawr@uwo.ca

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 4BQ
        • Lawson Research Institute
        • Contact:
          • Keith St Lawrence, PhD
          • Phone Number: 65737 (519) 646-6100
          • Email: kstlawr@uwo.ca
        • Principal Investigator:
          • Keith St Lawrence, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 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
Placebo drink containing flavored water.
Active Comparator: 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
D-Beta-Hydroxybutyrate bonded to R-1,3 Butanediol
Other Names:
  • KetoneAid
  • Veech Ketone Monoester

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
CMRO2 will be measured in both imaging sessions (placebo and 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.
CMRGlu will be measured in both imaging session (placebo and ketosis)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 7 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)
University of Western Ontario, Canada

Investigators

  • Principal Investigator: Keith St Lawrence, PhD, Lawson Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

May 1, 2028

Study Registration Dates

First Submitted

January 6, 2025

First Submitted That Met QC Criteria

January 6, 2025

First Posted (Actual)

January 9, 2025

Study Record Updates

Last Update Posted (Actual)

August 26, 2026

Last Update Submitted That Met QC Criteria

August 25, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 126350
  • 1R01NS131235-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Data release will follow a 36-month optional embargo to allow time for publication in a peer-reviewed journal.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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