Mild Cognitive ImpairmentAcAc PETNCT03130036
Biodistribution of [11C]Acetoacetate/[18F]Fluorodeoxyglucose in Subjects With Risk Factors for Alzheimer's Disease
A study testing [11C]Acetoacetate[18F]Fluorodeoxyglucose positron emission tomography scan in people with Mild Cognitive Impairment, run by Wake Forest University Health Sciences at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- [11C]Acetoacetate[18F]Fluorodeoxyglucose positron emission tomography scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jun 2015to 19 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Mild cognitive impairment or subjective memory complaints
- Stable medical condition and medications
- Ability to complete baseline assessments
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest School of Medicine
Winston-Salem, North Carolina, 27157
About this study
Official title: Biodistribution of [11C]Acetoacetate/[18F]Fluorodeoxyglucose in Subjects With Varying Risk Factors for Alzheimer's Disease and Subjects on a Diet Intervention
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.
Read the 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.
- Conditions
- Mild Cognitive Impairment
- Being tested
- [11C]Acetoacetate[18F]Fluorodeoxyglucose positron emission tomography scan
- Keywords
- Memory, Cognitive
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[11C]Acetoacetate[18F]Fluorodeoxyglucose positron emission tomography scanOther
A PET scan to measure uptake of acetoacetate and glucose in the brain will be administered to all participants enrolled in the study
| Study group | Role | What they receive |
|---|---|---|
| No risk of disease | Experimental | Subjects with no identifiable risk of Alzheimer's Disease Receives: Other: [11C]Acetoacetate[18F]Fluorodeoxyglucose positron emission tomography scan |
| Asymptomatic | Experimental | Asymptomatic subjects with increased risk of Alzheimer's disease Receives: 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) Receives: Other: [11C]Acetoacetate[18F]Fluorodeoxyglucose positron emission tomography scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain biodistribution of [11C]AcAc
To assess brain metabolism of ketones (cerebral metabolic rate of acetoacetate/micromilliliters/100 g/min)
Measured: Baseline
Brain biodistribution of [11C]AcAc
To assess change in brain metabolism of ketones (cerebral metabolic rate of acetoacetate/micromilliliters/100 g/min)
Measured: 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)
Measured: Baseline
Brain biodistribution of [18F]FDG -
To assess change in brain uptake of glucose (cerebral metabolic rate of glucose /micromilliliters/100 g/min)
Measured: Change between baseline and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2017
- Study start9 Jun 2015
- Primary completion19 Jun 2024
- Study completion19 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Suzanne Craft, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03130036
- Sponsor's protocol ID
- IRB00033365
- Acronym
- AcAc PET
- Status last verified
- Oct 2024
- First submitted
- 18 Apr 2017
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biodistribution of [11C]Acetoacetate/[18F]Fluorodeoxyglucose in Subjects With Varying Risk Factors for Alzheimer's Disease and Subjects on a Diet Intervention
- ClinicalTrials.gov ID
- NCT03130036
- Acronym / sponsor ID
- AcAc PET / IRB00033365
- Conditions
- Mild Cognitive Impairment
- Keywords
- Memory, Cognitive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 9 Jun 2015 (actual)
- Primary completion
- 19 Jun 2024 (actual)
- Study completion
- 19 Jun 2024 (actual)
- First posted
- 26 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No risk of disease | Experimental | Other: [11C]Acetoacetate[18F]Fluorodeoxyglucose positron emission tomography scanSubjects with no identifiable risk of Alzheimer's Disease |
| Asymptomatic | Experimental | Other: [11C]Acetoacetate[18F]Fluorodeoxyglucose positron emission tomography scanAsymptomatic subjects with increased risk of Alzheimer's disease |
| Early Alzheimer's or Mild Cognitive Impairment | Experimental | Other: [11C]Acetoacetate[18F]Fluorodeoxyglucose positron emission tomography scanSubjects with early Alzheimer's Disease or Mild Cognitive Impairment (MCI) |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Mild cognitive impairment or subjective memory complaints
- Stable medical condition and medications
- Ability to complete baseline assessments
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [11C]Acetoacetate[18F]Fluorodeoxyglucose positron emission tomography scanA PET scan to measure uptake of acetoacetate and glucose in the brain will be administered to all participants enrolled in the study | Other | Asymptomatic, Early Alzheimer's or Mild Cognitive Impairment, No risk of disease |
Primary outcome
Brain biodistribution of [11C]AcAc
Time frame: Baseline
To assess brain metabolism of ketones (cerebral metabolic rate of acetoacetate/micromilliliters/100 g/min)
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)
Brain biodistribution of [18F]FDG -
Time frame: Baseline
To assess brain uptake of glucose (cerebral metabolic rate of glucose /micromilliliters/100 g/min)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suzanne Craft, PhD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing [11C]Acetoacetate[18F]Fluorodeoxyglucose positron emission tomography scan in people with Mild Cognitive Impairment, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain biodistribution of [11C]AcAc (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2025; AzTrials last refreshed its copy on 7 Nov 2026.