Actively Recruiting

Phase 1
Age: 50Years - 100Years
All Genders
Healthy Volunteers
NCT07169630

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

Led by National Institute of Mental Health (NIMH) · Updated on 2026-05-14

90

Participants Needed

1

Research Sites

203 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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....

CONDITIONS

Official Title

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

Who Can Participate

Age: 50Years - 100Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 50 years or older
  • Able to understand the study and sign informed consent (or have a legally authorized representative do so)
  • Diagnosed by a neurologist or psychiatrist with Alzheimer's disease or mild cognitive impairment
  • In good general health based on medical history and physical exam
  • Have adequate ulnar collateral blood flow and no metal or foreign objects in both wrists
  • Agree to follow lifestyle considerations
  • Healthy volunteers must be 50 or older, able to consent, in good health, have no cognitive impairment, and meet wrist blood flow and metal object criteria
Not Eligible

You will not qualify if you...

  • Clinically significant abnormalities in EKG or lab tests including CBC and acute care panel
  • Taken NSAIDs in the 2 weeks before PET scan; no aspirin, corticosteroids (except skin products), or immunosuppressants in the prior month
  • Other major neurological or medical diseases causing cognitive dysfunction
  • Unstable medical conditions making participation unsafe
  • Unable to travel to the NIH
  • Recent exposure to research-related radiation exceeding limits
  • Unable to lie flat and still on scanner bed for at least two hours due to claustrophobia, excessive weight, or behavioral symptoms
  • Substance use or alcohol use disorder
  • Current or prior treatment with amyloid antibodies like lecanemab
  • Unable to have MRI scan due to implanted devices or metal objects
  • Pregnant or breastfeeding
  • HIV infection
  • Non-English speaking
  • Children excluded due to radiation risk
  • Pregnancy test required for women of childbearing potential

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

National Institutes of Health Clinical Center

Bethesda, Maryland, United States, 20892

Actively Recruiting

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Research Team

T

Tara N Turon, C.R.N.P.

CONTACT

P

Paul A Parcon, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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