RecruitingPhase 1NCT07169630

PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)

PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer s Disease (AD) or Mild Cognitive Impairment (MCI)


Sponsor

National Institute of Mental Health (NIMH)

Enrollment

90 participants

Start Date

May 7, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

Background: About 5 million adults in the United States have age-related brain disorders. These include Alzheimer disease (AD), mild cognitive impairment (MCI), and other dementias. The number of people with these disorders will likely increase as the population ages and life span increases. Inflammation is thought to play a role in AD and MCI. Researchers want to know if an enzyme called PDE4B increases inflammation in people with AD or MCI. Objective: To test whether medical imaging using a new radiotracer (\[18F\]PF-06445974) can measure PDE4B in the brains of people with AD or MCI. Eligibility: People aged 50 years and older with AD or MCI. Healthy volunteers are also needed. Design: Participants will have up to 5 clinic visits with 3 imaging scans of the brain. They will have be screened. They will have a physical exam with blood tests. This will include tests of their heart and nerve function, including memory. Participants will have 2 positron emission tomography (PET) scans. One will use a standard radiotracer. The other will use the study radiotracer. They will receive each tracer through a tube attached to a needle inserted into a vein. During the scan with the study tracer, participants will have a second tube inserted into a vein in the wrist; this tube will be used to draw blood during the scan. Participants will lie on a bed that slides into a doughnut-shaped machine. These visits will take about 6 hours each. Participants will have 1 magnetic resonance imaging (MRI) scan. They will lie on a bed that slides into a cylinder. This visit will take up to 2 hours....


Eligibility

Min Age: 50 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study uses a special brain imaging technique (PET scan) with a tracer that highlights an enzyme called PDE4, which plays a role in brain signaling and may be affected in Alzheimer's disease and mild cognitive impairment (MCI). The goal is to better understand brain changes in these conditions — this is not a treatment trial. **You may be eligible if...** - You are 50 years or older - A neurologist or psychiatrist has diagnosed you with Alzheimer's disease or mild cognitive impairment (MCI) - You are in generally good health - You are able to understand the study and consent to participate (or have a legal representative who can) - Your wrist pulse indicates adequate circulation for the scan procedure **You may NOT be eligible if...** - You have conditions that prevent safe PET scanning (such as certain implanted devices) - You are unable to lie still in the scanner - You have other major neurological conditions unrelated to Alzheimer's - You are unable to provide or have a representative provide informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG18F-PF974

Injected IV followed by PET scanning

DRUG18F-florbetaben

Injected IV followed by PET scanning


Locations(1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

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NCT07169630


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