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

December 12, 2023 updated by: Wake Forest University Health Sciences

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

48 years to 83 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: No risk of disease
Subjects with no identifiable risk of Alzheimer's Disease
Other: [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
Experimental: Asymptomatic
Asymptomatic subjects with increased risk of Alzheimer's disease
Other: [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
Experimental: Early Alzheimer's or Mild Cognitive Impairment
Subjects with early Alzheimer's Disease or Mild Cognitive Impairment (MCI)
Other: [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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brain biodistribution of [11C]AcAc
Time Frame: Baseline
To assess brain metabolism of ketones (cerebral metabolic rate of acetoacetate/micromilliliters/100 g/min)
Baseline
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)
Change between baseline and four months
Brain biodistribution of [18F]FDG -
Time Frame: Baseline
To assess brain uptake of glucose (cerebral metabolic rate of glucose /micromilliliters/100 g/min)
Baseline
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)
Change between baseline and 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Investigators

  • Principal Investigator: Suzanne Craft, PhD, Wake Forest University Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 9, 2015

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

April 18, 2017

First Submitted That Met QC Criteria

April 21, 2017

First Posted (Actual)

April 26, 2017

Study Record Updates

Last Update Posted (Estimated)

December 13, 2023

Last Update Submitted That Met QC Criteria

December 12, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00033365

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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