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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-09

Study Completion Date

2024-06-19

Brief Summary

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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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Detailed Description

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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.

Conditions

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Mild Cognitive Impairment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Investigators

No masking is used

Study Groups

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No risk of disease

Subjects with no identifiable risk of Alzheimer's Disease

Group Type EXPERIMENTAL

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

Intervention Type OTHER

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

Asymptomatic

Asymptomatic subjects with increased risk of Alzheimer's disease

Group Type EXPERIMENTAL

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

Intervention Type OTHER

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

Early Alzheimer's or Mild Cognitive Impairment

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

Group Type EXPERIMENTAL

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

Intervention Type OTHER

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

Interventions

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

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes