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

Not Applicable

Completed

• Conditions: Mild Cognitive Impairment
• Interventions: Other: [11C]Acetoacetate[18F]Fluorodeoxyglucose positron emission tomography scan

• Registration Number: NCT03130036
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2015-06-09
• Study First Submitted: 2017-04-18
• Study First Submitted QC: 2017-04-21
• Study First Posted: 2017-04-26
• Primary Completion: 2024-06-19
• Study Completion: 2024-06-19
• Status Verified: 2024-10
• Last Update Submitted: 2024-11-27
• Last Update Posted: 2024-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Asymptomatic	[11C]Acetoacetate[18F]Fluorodeoxyglucose positron emission tomography scan	Asymptomatic subjects with increased risk of Alzheimer's disease
No risk of disease	[11C]Acetoacetate[18F]Fluorodeoxyglucose positron emission tomography scan	Subjects with no identifiable risk of Alzheimer's Disease
Early Alzheimer's or Mild Cognitive Impairment	[11C]Acetoacetate[18F]Fluorodeoxyglucose positron emission tomography scan	Subjects with early Alzheimer's Disease or Mild Cognitive Impairment (MCI)

Primary Outcome Measures

Name	Time	Method
Brain biodistribution of [11C]AcAc	Change between baseline and four months	To assess change in brain metabolism of ketones (cerebral metabolic rate of acetoacetate/micromilliliters/100 g/min)
Brain biodistribution of [18F]FDG -	Change between baseline and 4 months	To assess change in brain uptake of glucose (cerebral metabolic rate of glucose /micromilliliters/100 g/min)

Trial Locations

Locations (1)

Wake Forest School of Medicine; 🇺🇸 Winston-Salem, North Carolina, United States