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PET Imaging of PDE4 in Alzheimer's or Mild Cognitive Impairment

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What is being tested

18F-PF974

+ 18F-florbetaben
Drug
Who is being recruted

Alzheimer s Disease

+ Mild Cognitive Impairment
+ Healthy
From 50 to 100 Years
+25 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Diagnostic Study

Phase 1
Interventional
Study Start: November 2025

See protocol details

Summary

Principal SponsorNational Institute of Mental Health (NIMH)
Study ContactTara N Turon, C.R.N.P.
Last updated: November 5, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: November 10, 2025Actual date on which the first participant was enrolled.

This study focuses on understanding the presence of a specific protein, called PDE4B, in the brains of individuals with Alzheimer's Disease (AD) or Mild Cognitive Impairment (MCI). Researchers believe that people with these conditions may have higher levels of PDE4B in certain areas of the brain compared to healthy individuals of the same age. This study is important because it could help identify a new marker for detecting and understanding these conditions better, potentially leading to improved diagnosis and treatment options for those affected by Alzheimer's and similar cognitive impairments. Participants in this study undergo several brain scans, including two types of PET scans and an MRI. These scans help researchers measure the levels of PDE4B and beta-amyloid, another protein linked to Alzheimer's. By comparing these measurements between patients with AD or MCI and healthy volunteers, the study aims to see if there is a noticeable difference in PDE4B levels that correlates with the disease. Additionally, the study looks at other factors like age, sex, and clinical tests to see how they might relate to the protein levels. The safety of participants is ensured throughout the process, with the main aim being to gather valuable information rather than testing new treatments.

Official TitlePET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer s Disease (AD) or Mild Cognitive Impairment (MCI) 
Principal SponsorNational Institute of Mental Health (NIMH)
Study ContactTara N Turon, C.R.N.P.
Last updated: November 5, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
90 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Diagnostic Study
Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 50 to 100 YearsRange of ages for which participants are eligible to join.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Alzheimer s Disease
Mild Cognitive Impairment
Healthy
Criteria
8 inclusion criteria required to participate
Agree to adhere to the lifestyle considerations.
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.
Aged 50 or older.
Be in good general health, as evidenced by medical history and physical examination, and have no cognitive impairment.

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17 exclusion criteria prevent from participating
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 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.

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
All subjects will receive the same tests.
Study Objectives
Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Recruiting
National Institutes of Health Clinical CenterBethesda, United StatesSee the location
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One Study Center