PET Imaging of PDE4 in Alzheimer's Disease and Mild Cognitive Impairment
This study is looking at how an enzyme called PDE4B might be involved in Alzheimer's disease (AD) and mild cognitive impairment (MCI). Researchers believe that PDE4B could increase inflammation in the brain for people with these conditions. The study uses special brain scans called PET scans with two injected drugs, 18F-PF974 and 18F-florbetaben, to measure PDE4B levels. The main goal is to see if people with AD or MCI have higher levels of PDE4B in a specific brain area compared to healthy volunteers. You can join if you are 50 years or older and have a suspected diagnosis of AD or MCI, or if you are a healthy volunteer.
- Study design
- This interventional study plans to enroll 90 participants, including those with Alzheimer's disease, mild cognitive impairment, and healthy volunteers.
- What's involved
- Participants will have up to 5 clinic visits, including 3 brain imaging scans (two PET scans and one MRI scan).
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint is measured at 48 months.
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NCT07169630
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Recruiting
PHASE1Ages 50+InterventionalDiagnosticNational Institute of Mental Health (NIMH)Government-funded
~90 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:18F-PF97418F-florbetaben
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To determine whether PDE4B radioligand binding is increased in medial temporal lobe of participants with AD or MCI (both A <= positive) compared to age-and sex matched HVs (who are A <= negative.
Measured over 48 months
Conditions
Where it's being run
1 sites across 1 statesMaryland1
Study leadership
- Paul A Parcon, M.D. · PRINCIPAL_INVESTIGATOR · National Institute of Mental Health (NIMH)
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Aged 50 or older.
Be able (or have their Legally Authorized Representative (LAR) be able) to understand the study and be willing to sign a written informed consent document.
Have been diagnosed by a neurologist or psychiatrist with MCI or AD.
Be in good general health as evidenced by medical history and physical examination.
Have had their radial artery pulse checked for the presence of adequate ulnar collateral flow and the absence of any metal or foreign objects in both wrists.
Agree to adhere to the lifestyle considerations.
Aged 50 or older.
Able to provide informed consent.
Be in good general health, as evidenced by medical history and physical examination, and have no cognitive impairment.
Have had their radial artery pulse checked for the presence of adequate ulnar collateral flow and the absence of any metal or foreign objects in both wrists.
Agree to adhere to the lifestyle considerations.
Exclusion
Clinically significant abnormalities on EKG or laboratory testing. This includes CBC and acute care panel (Na, K, Cl, CO2, creatinine, glucose, urea nitrogen).
Participants should not have taken non-steroidal anti-inflammatory drugs (NSAIDs) for two weeks prior to the PET scan. Aspirin, corticosteroids (with the exception of skin products), or immunosuppressants (e.g., methotrexate) must not have been taken in the prior month.
Have other major neurological or medical diseases that may cause cognitive dysfunction, such as structural brain diseases, metabolic diseases, paraneoplastic syndromes, infectious diseases, or other significant neurological abnormalities.
Have an unstable medical condition that, in the opinion of the investigators, makes participation unsafe (e.g., an active infection or untreated malignancy).
Are unable to travel to the NIH.
Have recent exposure to radiation related to research (e.g., PET from other research) that, when combined with this study, would be above the allowable limits.
Have an inability to lie flat and/or lie still on the camera bed for at least two hours, including claustrophobia, overweight greater than the maximum for the scanner, and uncontrollable behavioral symptoms, which will be screened by an interview with the volunteer and/or caregiver during the screening visit.
Participants must not have substance use disorder or alcohol use disorder.
Participants should not be under treatment or previously treated with an amyloid antibody such as lecanemab.
Are unable to have an MRI scan (e.g., because of pacemakers or other implanted electrical devices, brain stimulators, dental implants, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, implanted delivery pumps, shrapnel fragments, or metal fragments in the eye).
Pregnancy or breast feeding.
HIV infection.
Non-English speaking participants.
What this trial measures
- To determine whether PDE4B radioligand binding is increased in medial temporal lobe of participants with AD or MCI (both A <= positive) compared to age-and sex matched HVs (who are A <= negative.48 months