Mild Cognitive Impairment
Conditions
Keywords
Memory, Cognitive
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.
Interventions
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
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Investigator)
Masking description
No masking is used
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Brain biodistribution of [11C]AcAc | Baseline | To assess brain metabolism of ketones (cerebral metabolic rate of acetoacetate/micromilliliters/100 g/min) |
| Brain biodistribution of [18F]FDG - | Baseline | To assess brain uptake of glucose (cerebral metabolic rate of glucose /micromilliliters/100 g/min) |
Countries
United States
Outcome results
None listed