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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No risk of disease | Experimental | Subjects with no identifiable risk of Alzheimer's Disease |
|
| Asymptomatic | Experimental | Asymptomatic subjects with increased risk of Alzheimer's disease |
|
| Early Alzheimer's or Mild Cognitive Impairment | Experimental | Subjects with early Alzheimer's Disease or Mild Cognitive Impairment (MCI) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [11C]Acetoacetate[18F]Fluorodeoxyglucose positron emission tomography scan | Other | A PET scan to measure uptake of acetoacetate and glucose in the brain will be administered to all participants enrolled in the study |
| Measure | Description | Time Frame |
|---|---|---|
| Brain biodistribution of [11C]AcAc | To assess brain metabolism of ketones (cerebral metabolic rate of acetoacetate/micromilliliters/100 g/min) | Baseline |
| Brain biodistribution of [11C]AcAc | 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 - | To assess brain uptake of glucose (cerebral metabolic rate of glucose /micromilliliters/100 g/min) | Baseline |
| Brain biodistribution of [18F]FDG - | To assess change in brain uptake of glucose (cerebral metabolic rate of glucose /micromilliliters/100 g/min) | Change between baseline and 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Suzanne Craft, PhD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest School of Medicine | Winston-Salem | North Carolina | 27157 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Dec 19, 2023 | Nov 27, 2024 |
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No masking is used
| ICF_000.pdf |
| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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