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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03130036
Recruitment Status : Active, not recruiting
First Posted : April 26, 2017
Last Update Posted : April 21, 2020
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

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.

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Other: [11C]Acetoacetate[18F]Fluorodeoxyglucose positron emission tomography scan Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Masking Description: No masking is used
Primary Purpose: Basic Science
Official Title: Biodistribution of [11C]Acetoacetate/[18F]Fluorodeoxyglucose in Subjects With Varying Risk Factors for Alzheimer's Disease and Subjects on a Diet Intervention
Actual Study Start Date : June 9, 2015
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : February 2023


Arm Intervention/treatment
Experimental: No risk of disease
Subjects with no identifiable risk of Alzheimer's Disease
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

Experimental: Asymptomatic
Asymptomatic subjects with increased risk of Alzheimer's disease
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

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




Primary Outcome Measures :
  1. Brain biodistribution of [11C]AcAc [ Time Frame: Baseline ]
    To assess brain metabolism of ketones (cerebral metabolic rate of acetoacetate/micromilliliters/100 g/min)

  2. Brain biodistribution of [11C]AcAc [ Time Frame: Change between baseline and four months ]
    To assess change in brain metabolism of ketones (cerebral metabolic rate of acetoacetate/micromilliliters/100 g/min)

  3. Brain biodistribution of [18F]FDG - [ Time Frame: Baseline ]
    To assess brain uptake of glucose (cerebral metabolic rate of glucose /micromilliliters/100 g/min)

  4. Brain biodistribution of [18F]FDG - [ Time Frame: Change between baseline and 4 months ]
    To assess change in brain uptake of glucose (cerebral metabolic rate of glucose /micromilliliters/100 g/min)



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03130036


Locations
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United States, North Carolina
Wake Forest School of Medicine
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
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Principal Investigator: Suzanne Craft, PhD Wake Forest University Health Sciences
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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03130036    
Other Study ID Numbers: IRB00033365
First Posted: April 26, 2017    Key Record Dates
Last Update Posted: April 21, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wake Forest University Health Sciences:
Memory
Cognitive
Additional relevant MeSH terms:
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Alzheimer Disease
Cognitive Dysfunction
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders
Fluorodeoxyglucose F18
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action