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

Wake Forest University (WFU)

Status: Completed

Conditions: Mild Cognitive Impairment

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03130036

IRB00033365

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 patients

Sex: All

Ages: 50 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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42 participants in 3 patient groups

No risk of disease

Experimental group

Description:

Subjects with no identifiable risk of Alzheimer's Disease

Treatment:

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

Asymptomatic

Experimental group

Description:

Asymptomatic subjects with increased risk of Alzheimer's disease

Treatment:

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

Early Alzheimer's or Mild Cognitive Impairment

Experimental group

Description:

Subjects with early Alzheimer's Disease or Mild Cognitive Impairment (MCI)

Treatment:

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