Supplementing Neuro-Energy to Aid Cognition

Not Applicable

Not yet recruiting

• Conditions: Alzheimer Disease and Related Dementias (ADRD)

• Registration Number: NCT06767124
• Lead Sponsor: University of Pennsylvania

Brief 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. 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 Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-06
• Study First Submitted QC: 2025-01-06
• Last Update Submitted: 2025-01-06
• Study First Posted: 2025-01-09
• Last Update Posted: 2025-01-09
• Study Start: 2025-07-01
• Primary Completion: 2028-02-29
• Study Completion: 2028-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

Not provided

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Cerebral Metabolic Rate of Oxygen (CMRO2)	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)	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 Outcome Measures

Name	Time	Method
Cognitive Function	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.

Trial Locations

Locations (1)

Lawson Research Institute; 🇨🇦 London, Ontario, Canada