ClinicalTrials.gov
ClinicalTrials.gov Menu

Biodistribution of [11C]Acetoacetate/[18F]Fluorodeoxyglucose Using Positron Emission Tomography (PET) Scanning

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 : Completed
First Posted : April 26, 2017
Last Update Posted : August 1, 2018
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief Summary:
This is a single center imaging study that will recruit 30 participants who are enrolled in the Brain Energy And Memory study (BEAM) protocol. This cohort of patients, aged 50-85, 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
Alzheimer Disease Mild Cognitive Impairment Other: Low-Carbohydrate Diet Other: Low-Fat Diet Not Applicable

Detailed Description:
This study will examine the brain biodistribution of [11C]AcAc/[18F]FDG, a proxy for acetoacetate (ketone body)/glucose metabolism, in asymptomatic individuals with increased risk of Alzheimer's disease, those without identifiable risk of Alzheimer's disease, and those with early Alzheimer's disease or MCI. Data collected in this study will help provide a more comprehensive understanding of brain energy metabolism (both glucose and ketone bodies) in several groups of participants including adults with and without signs of memory impairment.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Masking Description: The PI and cognitive assessor were blinded as to diet condition.
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 Ketogenic Diet
Actual Study Start Date : June 9, 2015
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017


Arm Intervention/treatment
Experimental: LOW-CARBOHYDRATE DIET
The low-carbohydrate diet will consist of a meal plan of less than 20 grams of carbohydrates per day to be consumed over 6 weeks. Foods that provide high levels of healthy fats (preferably low in saturated fats) will be generously included in the diet plan. Various lean meats, fish, and nutrient rich foods that meet the requirement of less than 20 grams total carbohydrates per day will be included in the meal plans. Carbohydrates will be expected to make up less than 10% of total caloric intake. Participants in the low-carbohydrate diet group will receive a supply of extra virgin olive oil at study visits to incorporate into their individualized meal plans.
Other: Low-Carbohydrate Diet
Participants assigned to the Modified Ketogenic-Mediterranean Diet will keep their carbohydrate consumption below 20 grams per day throughout the 6-week intervention.

Experimental: LOW-FAT DIET
The low-fat diet will consist of a low-fat, higher-carbohydrate meal plan to be consumed over 6 weeks. Participants will be encouraged to limit their amount of fat intake to less than 40 grams per day, while eating plentiful fruits, vegetables, and carbohydrates containing adequate fiber. Various lean meats and other sources of protein will be included in the diet plan. Carbohydrates will be expected to make up 50-60% of total caloric intake.
Other: Low-Fat Diet
Participants assigned to the Low-Fat Diet will be encouraged to limit their amount of fat intake to <40 grams/day, while eating plentiful fruits, vegetables, and carbohydrates containing adequate fiber.




Primary Outcome Measures :
  1. Brain biodistribution of [11C]AcAc/[18F]FDG [ Time Frame: 18 weeks ]
    Differences in brain glucose and acetoacetate metabolism and how this relates to cognitive performance, metabolism, and other measures.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
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
Principal Investigator: Suzanne Craft, PhD Wake Forest University Health Sciences

Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03130036     History of Changes
Other Study ID Numbers: IRB00033365
First Posted: April 26, 2017    Key Record Dates
Last Update Posted: August 1, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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:
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