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

NCT03130036 | Completed

• 1 other identifier: IRB00033365
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment

Keywords

Memory; Cognitive

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (3)

No risk of disease

EXPERIMENTAL

Subjects with no identifiable risk of Alzheimer's Disease

Other: [11C]Acetoacetate[18F]Fluorodeoxyglucose positron emission tomography scan

Asymptomatic

EXPERIMENTAL

Asymptomatic subjects with increased risk of Alzheimer's disease

Other: [11C]Acetoacetate[18F]Fluorodeoxyglucose positron emission tomography scan

Early Alzheimer's or Mild Cognitive Impairment

EXPERIMENTAL

Subjects with early Alzheimer's Disease or Mild Cognitive Impairment (MCI)

Other: [11C]Acetoacetate[18F]Fluorodeoxyglucose positron emission tomography scan

Interventions

[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

Asymptomatic; Early Alzheimer's or Mild Cognitive Impairment; No risk of disease

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mild cognitive impairment or subjective memory complaints
• Stable medical condition and medications
• Ability to complete baseline assessments

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest School of Medicine

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Suzanne Craft, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: No masking is used
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2017
• First Posted: April 26, 2017
• Study Start: June 9, 2015
• Primary Completion: June 19, 2024
• Study Completion: June 19, 2024
• Last Updated: July 28, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)