PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cogni… (NCT07169630) | Clinical Trial Compass
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
United States90 participantsStarted 2026-07-01
Plain-language 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....
Who can participate
Age range
50 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* INCLUSION CRITERIA:
Participants will be referred by a physician with the suspected diagnosis of AD or MCI. However, the PI of this protocol will provide the final diagnosis. For this reason, this protocol will have just one consent form for participants suspected of having either AD or MCI.
AD and MCI Study Groups:
Participants must meet all the following criteria:
* 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.
Healthy Volunteers:
Participants must meet all the following criteria:
* 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 CRITERIA:
Both the study groups will be excluded if they meet any of the following criteria:
* Clinicall…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This is a Phase 1 imaging study — does that mean it's primarily about testing the safety and usefulness of the PET scan itself rather than trying to treat my Alzheimer's or MCI, and what would I actually gain from participating?
2The trial involves a PET radioligand called a PDE4B tracer — can you explain what that radioligand is, how much radiation exposure it involves, and whether that level of exposure is a concern given my age and health?
3The study requires participants to be 'amyloid positive' — do I already have amyloid imaging or biomarker results that would confirm whether I meet that criterion, or would I need additional testing first?
4Since this trial is measuring a brain protein called PDE4B in the medial temporal lobe, would the scan results give me or my doctors any actionable information about my diagnosis or care, or would the data primarily benefit future research?
5Given that this is a research imaging study rather than a treatment trial, would it make more sense to prioritize enrolling in a treatment-focused trial first, or could I potentially pursue both at the same time?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.