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PET Scans for Alzheimer's Disease (AcAc PET Trial)

N/A
Waitlist Available
Led By Suzanne Craft, PhD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Mild cognitive impairment or subjective memory complaints
Ability to complete baseline assessments
Must not have
History of a clinically significant stroke
Sensory impairment (visual, auditory)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights
No Placebo-Only Group

Summary

This trial will study Alzheimer's Disease biomarkers and symptoms in patients following a ketogenic diet. Up to 60 patients will receive 3 PET scans over 18 weeks.

Who is the study for?
This trial is for individuals with mild cognitive impairment or memory concerns who are stable medically and can complete initial assessments. It's not suitable for those with a significant stroke history, sensory impairments, diabetes needing drugs, untreated thyroid or B12 issues, or those on certain medications like cholesterol-lowering drugs.
What is being tested?
The study tests how [11C]Acetoacetate and [18F]Fluorodeoxyglucose distribute in the brain using PET scans. Participants from the BEAT-AD Study will have up to three scans over 18 weeks to see how these compounds behave in people at risk for Alzheimer's.
What are the potential side effects?
As this is an imaging study involving PET scans, side effects may include discomfort from lying still during the scan and exposure to a small amount of radiation comparable to that received during some medical imaging procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I experience memory problems or have been told I have mild cognitive issues.
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I can complete initial health questionnaires and tests.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a serious stroke in the past.
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I have a significant hearing or vision problem.
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I take medication for my diabetes.
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I have not treated my underactive thyroid or B12 deficiency.
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I am currently taking medication for cholesterol, seizures, or other drugs that might affect my brain function.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Brain biodistribution of [11C]AcAc
Brain

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: No risk of diseaseExperimental Treatment1 Intervention
Subjects with no identifiable risk of Alzheimer's Disease
Group II: Early Alzheimer's or Mild Cognitive ImpairmentExperimental Treatment1 Intervention
Subjects with early Alzheimer's Disease or Mild Cognitive Impairment (MCI)
Group III: AsymptomaticExperimental Treatment1 Intervention
Asymptomatic subjects with increased risk of Alzheimer's disease

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,398 Previous Clinical Trials
2,460,168 Total Patients Enrolled
Suzanne Craft, PhDPrincipal InvestigatorWake Forest University Health Sciences
16 Previous Clinical Trials
1,977 Total Patients Enrolled

Media Library

[11C]Acetoacetate[18F]Fluorodeoxyglucose positron emission tomography scan Clinical Trial Eligibility Overview. Trial Name: NCT03130036 — N/A
Mild Cognitive Impairment Research Study Groups: Asymptomatic, Early Alzheimer's or Mild Cognitive Impairment, No risk of disease
Mild Cognitive Impairment Clinical Trial 2023: [11C]Acetoacetate[18F]Fluorodeoxyglucose positron emission tomography scan Highlights & Side Effects. Trial Name: NCT03130036 — N/A
[11C]Acetoacetate[18F]Fluorodeoxyglucose positron emission tomography scan 2023 Treatment Timeline for Medical Study. Trial Name: NCT03130036 — N/A
~4 spots leftby Dec 2025
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