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

Mild Cognitive Impairment Clinical Trial

— 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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03130036
• Other study ID #: IRB00033365
• Status: Enrolling by invitation
• Phase: N/A
• Start date: June 9, 2015
• Est. completion date: June 2024

Study information

• Verified date: December 2023
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

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

Locations

Country	Name	City	State
United States	Wake Forest School of Medicine	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brain biodistribution of [11C]AcAc	To assess brain metabolism of ketones (cerebral metabolic rate of acetoacetate/micromilliliters/100 g/min)	Baseline
Primary	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
Primary	Brain biodistribution of [18F]FDG -	To assess brain uptake of glucose (cerebral metabolic rate of glucose /micromilliliters/100 g/min)	Baseline
Primary	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