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NCT Number: NCT06767124

Supplementing Neuro-Energy to Aid Cognition

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lawson Research Institute

London, Ontario, N6A 4BQ, Canada

Location contact

Keith St Lawrence, PhD

CONTACT

[email protected]

(519) 646-6100 ext. 65737

Keith St Lawrence, PhD

PRINCIPAL_INVESTIGATOR

About this study

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 can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

- Healthy Participants: Males and females, Age 21 - 80 years, BMI of 18.5-30

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

Treatment and study plan

Ketogenic Supplement

Dietary Supplement

Commercially available ketone ester drink

Other names: Ketone-IQTM

Placebo drink

Other

Placebo drink containing sunflower oil.

Primary outcomes

  1. 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.

  2. Cerebral Metabolic Rate of Glucose (CMRGlu)

    Time frame: CMRGlu will be measued in both imaging session (placebo and ketosis)

    Statistical analysis of imaging data sets under palcebo and ketosis conditions will be used to investigate changes in regional CMRGlu caused by ketosis. Unlikek CMRO2, no difference in CMRGlu is expected between the two conditions for Alzheimer's patients.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Keith St Lawrence, PhD

CONTACT

[email protected]

(519) 646-6100 ext. 65737

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

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

Registry information

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jan 9, 2025
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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