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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 change between baseline and four months

Awards & highlights

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ change between baseline and 4 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change between baseline and 4 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and change between baseline and 4 months 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

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

0 / 7Eligibility criteria met

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Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor

1,266 Previous Clinical Trials

1,013,647 Total Patients Enrolled

Suzanne Craft, PhDPrincipal InvestigatorWake Forest University Health Sciences

16 Previous Clinical Trials

2,007 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

~0 spots leftby Oct 2024

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