Back to resultsBiodistribution of [11C]Acetoacetate/[18F]Fluorodeoxyglucose in Subjects With Risk Factors for Alzheimer's Disease (AcAc PET)
Primary Purpose
Mild Cognitive Impairment
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
[11C]Acetoacetate[18F]Fluorodeoxyglucose positron emission tomography scan
Sponsored by
About this trial
This is an interventional basic science trial for Mild Cognitive Impairment focused on measuring Memory, Cognitive
Eligibility Criteria
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
Sites / Locations
- Wake Forest School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
No risk of disease
Asymptomatic
Early Alzheimer's or Mild Cognitive Impairment
Arm Description
Subjects with no identifiable risk of Alzheimer's Disease
Asymptomatic subjects with increased risk of Alzheimer's disease
Subjects with early Alzheimer's Disease or Mild Cognitive Impairment (MCI)
Outcomes
Primary Outcome Measures
Brain biodistribution of [11C]AcAc
To assess brain metabolism of ketones (cerebral metabolic rate of acetoacetate/micromilliliters/100 g/min)
Brain biodistribution of [11C]AcAc
To assess change in brain metabolism of ketones (cerebral metabolic rate of acetoacetate/micromilliliters/100 g/min)
Brain biodistribution of [18F]FDG -
To assess brain uptake of glucose (cerebral metabolic rate of glucose /micromilliliters/100 g/min)
Brain biodistribution of [18F]FDG -
To assess change in brain uptake of glucose (cerebral metabolic rate of glucose /micromilliliters/100 g/min)
Secondary Outcome Measures
Full Information
NCT ID
NCT03130036
First Posted
April 18, 2017
Last Updated
December 22, 2022
Sponsor
Wake Forest University Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT03130036
Brief Title
Biodistribution of [11C]Acetoacetate/[18F]Fluorodeoxyglucose in Subjects With Risk Factors for Alzheimer's Disease
Acronym
AcAc PET
Official Title
Biodistribution of [11C]Acetoacetate/[18F]Fluorodeoxyglucose in Subjects With Varying Risk Factors for Alzheimer's Disease and Subjects on a Diet Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
June 9, 2015 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
Memory, Cognitive
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
No masking is used
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
No risk of disease
Arm Type
Experimental
Arm Description
Subjects with no identifiable risk of Alzheimer's Disease
Arm Title
Asymptomatic
Arm Type
Experimental
Arm Description
Asymptomatic subjects with increased risk of Alzheimer's disease
Arm Title
Early Alzheimer's or Mild Cognitive Impairment
Arm Type
Experimental
Arm Description
Subjects with early Alzheimer's Disease or Mild Cognitive Impairment (MCI)
Intervention Type
Other
Intervention Name(s)
[11C]Acetoacetate[18F]Fluorodeoxyglucose positron emission tomography scan
Intervention Description
A PET scan to measure uptake of acetoacetate and glucose in the brain will be administered to all participants enrolled in the study
Primary Outcome Measure Information:
Title
Brain biodistribution of [11C]AcAc
Description
To assess brain metabolism of ketones (cerebral metabolic rate of acetoacetate/micromilliliters/100 g/min)
Time Frame
Baseline
Title
Brain biodistribution of [11C]AcAc
Description
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
Title
Brain biodistribution of [18F]FDG -
Description
To assess brain uptake of glucose (cerebral metabolic rate of glucose /micromilliliters/100 g/min)
Time Frame
Baseline
Title
Brain biodistribution of [18F]FDG -
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzanne Craft, PhD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest School of Medicine
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Biodistribution of [11C]Acetoacetate/[18F]Fluorodeoxyglucose in Subjects With Risk Factors for Alzheimer's Disease
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