Clinical trial NCT06767124: Supplementing Neuro-Energy to Aid Cognition
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Alzheimer Disease and Related Dementias (ADRD)
Keywords: PET/MR, Keytone Supplement, Brain Energy Metabolism
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
name: University of Western Ontario, Canada
First posted: 2025-01-09
Enrollment: 17
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Each patient receives a placebo and the active treatment on separate occasions undergoing the same imaging protocol.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cerebral Metabolic Rate of Oxygen (CMRO2)
timeFrame: CMRO2 will be measured in both imaging sessions (placebo and ketosis)
measure: Cerebral Metabolic Rate of Glucose (CMRGlu)
timeFrame: CMRGlu will be measued in both imaging session (placebo and ketosis)
Secondary outcomes:
measure: Cognitive Function
timeFrame: Baseline and 7 Days
Other outcomes:
Locations:
city: London
country: Canada
facility: Lawson Research Institute
state: Ontario
Study officials:
affiliation: Lawson Research Institute
name: Keith St Lawrence, PhD
role: PRINCIPAL_INVESTIGATOR
References: