Actively Recruiting
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
Eligibility Criteria
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
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
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
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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