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

Wake Forest University Health Sciences42 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Enrollment

Conditions

Mild Cognitive Impairment

Interventions

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

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

Eligibility

Sex: ALLMin age: 50 YearsMax age: 85 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Wake Forest School of Medicine

Winston-Salem, North Carolina, United States

Outcomes

Primary Outcomes

Brain biodistribution of [11C]AcAc

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

Time frame: Baseline

Brain biodistribution of [11C]AcAc

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

Time frame: Change between baseline and four months

Brain biodistribution of [18F]FDG -

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

Time frame: Baseline

Brain biodistribution of [18F]FDG -

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

Time frame: Change between baseline and 4 months

Data from ClinicalTrials.gov

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