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Completed

NCT Number: NCT03130036

Biodistribution of [11C]Acetoacetate/[18F]Fluorodeoxyglucose in Subjects With Risk Factors for Alzheimer's Disease

This is a single center imaging study that will recruit 60 participants who are enrolled in the Effect of a Ketogenic Diet on Alzheimer's Disease Biomarkers and Symptoms: Brain Energy for Amyloid Transformation in AD (BEAT-AD) Study protocol. This cohort of patients will receive a maximum of 3 [11C]Acetoacetate (AcAc)/[18F]Fluorodeoxyglucose (FDG) PET scans over 18 weeks as part of this supplemental trial.

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Key information

Conditions

Mild Cognitive Impairment Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest School of Medicine

Winston-Salem, North Carolina, 27157, United States

About this study

The main objective of this study is to examine the brain biodistribution of [11C]AcAc/[18F]FDG, a proxy for acetoacetate (ketone body)/glucose metabolism in 3 study groups; 1) those without identifiable risk of Alzheimer's disease, 2) asymptomatic individuals with increased risk of Alzheimer's disease (such as pre diabetes),and 3) those with early Alzheimer's disease or MCI. Secondary objectives include determining the association between adipose tissue distribution/function and biomarkers of AD pathology.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Mild cognitive impairment or subjective memory complaints
  • Stable medical condition and medications
  • Ability to complete baseline assessments

Exclusion criteria

  • History of a clinically significant stroke
  • Sensory impairment (visual, auditory)
  • Diabetes requiring medication
  • Current use of cholesterol/lipid lowering medications, anticonvulsants, drugs with potential interfering CNS effects (other than cholinesterase inhibitors or memantine), medications with significant anticholinergic activity, anti-parkinsonian medications or regular use of narcotic analgesics
  • Untreated hypothyroidism or B12 deficiency

Treatment and study plan

[11C]Acetoacetate[18F]Fluorodeoxyglucose positron emission tomography scan

Other

A PET scan to measure uptake of acetoacetate and glucose in the brain will be administered to all participants enrolled in the study

Primary outcomes

  1. Brain biodistribution of [11C]AcAc

    Time frame: Baseline

    To assess brain metabolism of ketones (cerebral metabolic rate of acetoacetate/micromilliliters/100 g/min)

  2. Brain biodistribution of [11C]AcAc

    Time frame: Change between baseline and four months

    To assess change in brain metabolism of ketones (cerebral metabolic rate of acetoacetate/micromilliliters/100 g/min)

  3. Brain biodistribution of [18F]FDG -

    Time frame: Baseline

    To assess brain uptake of glucose (cerebral metabolic rate of glucose /micromilliliters/100 g/min)

  4. Brain biodistribution of [18F]FDG -

    Time frame: Change between baseline and 4 months

    To assess change in brain uptake of glucose (cerebral metabolic rate of glucose /micromilliliters/100 g/min)

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

Biodistribution of [11C]Acetoacetate/[18F]Fluorodeoxyglucose in Subjects With Varying Risk Factors for Alzheimer's Disease and Subjects on a Diet Intervention

Acronym: AcAc PET

Important dates

Study start
2015
Primary completion
2024
Study completion
2024
First posted
Apr 26, 2017
Registry last updated
Jul 28, 2025

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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