PET Imaging for Alzheimer's Disease

Overseen By Paul A Parcon, M.D.

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: National Institute of Mental Health (NIMH)

Must not be taking: NSAIDs, Aspirin, Corticosteroids, Immunosuppressants

Disqualifiers: Neurological diseases, Unstable conditions, Radiation exposure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new PET scan can detect inflammation-related enzymes in individuals with Alzheimer's or mild cognitive impairment. By using a special tracer, such as 18F-florbetaben or 18F-PF974, the researchers hope to gain a better understanding of how these brain conditions develop. Individuals aged 50 or older, diagnosed with Alzheimer's or mild cognitive impairment, or those who are healthy, might be suitable candidates. Participants will need to visit the clinic for several scans and health checks. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative brain scan.

Will I have to stop taking my current medications?

The trial requires that you stop taking non-steroidal anti-inflammatory drugs (NSAIDs) two weeks before the PET scan and avoid aspirin, corticosteroids (except skin products), or immunosuppressants for a month before the scan. If you're on these medications, you may need to pause them to participate.

What prior data suggests that this imaging technique is safe for humans?

Research shows that 18F-florbetaben is generally safe for brain scans. Studies have found that this tracer does not cause safety issues when used in the recommended amounts. Patients usually tolerate it well, and it has been used in Alzheimer's disease imaging without major problems.

For the new tracer, 18F-PF-06445974, less information is available. Researchers are testing this new tracer to see if it can help image an enzyme called PDE4B, which is linked to inflammation in Alzheimer's and mild cognitive impairment. Since this trial is in an early stage, researchers are still collecting safety data. This phase mainly focuses on safety, so any problems will be watched closely.

In summary, 18F-florbetaben has a strong safety record, while 18F-PF-06445974 is still being studied for safety. Researchers will closely monitor participants in this trial to ensure their safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for Alzheimer's disease because they utilize innovative PET imaging agents, 18F-florbetaben and 18F-PF974, which can help visualize amyloid plaques in the brain with high precision. Unlike traditional treatments that often focus on symptom management, these imaging agents aim to enhance early and accurate diagnosis by directly targeting the pathological hallmark of Alzheimer's. This could revolutionize how Alzheimer's is detected, potentially leading to earlier interventions and better disease management.

What evidence suggests that this imaging method is effective for Alzheimer's Disease?

Research has shown that 18F-florbetaben PET imaging effectively detects amyloid beta plaques in the brain, which are linked to Alzheimer's disease. This aids in diagnosing Alzheimer's and other types of dementia. Studies indicate it provides a clear picture of plaque presence, facilitating early diagnosis.

In this trial, all participants will receive both 18F-florbetaben and 18F-PF974 imaging. Early animal research has shown that 18F-PF974 can successfully measure an enzyme called PDE4B. This enzyme is believed to increase inflammation in Alzheimer's and mild cognitive impairment (MCI). Although human data is limited, these findings suggest potential for this new tracer in understanding Alzheimer's disease. ^{2 4 6 7 8}

Who Is on the Research Team?

Paul A Parcon, M.D.

Principal Investigator

National Institute of Mental Health (NIMH)

Are You a Good Fit for This Trial?

This trial is for people aged 50 or older with Alzheimer's Disease (AD) or Mild Cognitive Impairment (MCI), as well as healthy volunteers. Participants will undergo physical exams, blood tests, and memory function assessments to ensure they're fit for the study.

Inclusion Criteria

Participants referred by a physician with the suspected diagnosis of AD or MCI, with final diagnosis provided by the PI

Participants in good general health as evidenced by medical history and physical examination

Healthy volunteers able to provide informed consent

Exclusion Criteria

Clinically significant abnormalities on EKG or laboratory testing, including CBC and acute care panel

Unstable medical condition making participation unsafe

Substance use disorder or alcohol use disorder

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Imaging

Participants undergo 2 PET scans and 1 MRI scan to measure PDE4B and beta-amyloid in the brain

Up to 5 visits

3 imaging visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging procedures

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• 18F-florbetaben
• 18F-PF974

Trial Overview The trial is testing a new radiotracer called [18F]PF-06445974 to see if it can measure an enzyme linked to inflammation in AD or MCI patients' brains. It involves up to five clinic visits with three brain scans: two PET scans using different tracers and one MRI scan.

How Is the Trial Designed?

Group I: One-Arm Experimental Treatment 2 Interventions

All subjects will receive the same tests.

Who Is Running the Clinical Trial?

National Institute of Mental Health (NIMH)

Lead Sponsor

Trials

3,007

Recruited

2,852,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07169630

PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers ... 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 ...

2. jnm.snmjournals.org jnm.snmjournals.org/content/63/12/1919

First-in-Human Evaluation of 18F-PF-06445974, a PET ... In vivo, PET imaging of 18F-PF-06445974 in cynomolgus monkeys showed good brain uptake, a high percentage of specific (i.e., blockable) binding, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11320856/

18F-FDG PET can effectively rule out conversion to dementia ... We aimed to estimate the value of brain 18 F-FDG PET for predicting the risk of dementia conversion and the risk of occurrence of a neurodegenerative pathology.

4. bmcneurosci.biomedcentral.com bmcneurosci.biomedcentral.com/articles/10.1186/s12868-025-00978-0

Comparative study of 18 F-labeled PET radiopharmaceuticals ... This study demonstrated that 18F-FBB and 18F-FMM are effective radiopharmaceuticals for amyloid imaging in AD mouse models, with 18F-FBB showing ...

5. patlynk.com patlynk.com/trial/NCT07169630

PET Imaging of PDE4 in Alzheimer's or Mild Cognitive ... This study focuses on understanding the presence of a specific protein, called PDE4B, in the brains of individuals with Alzheimer's Disease ...

6. jnm.snmjournals.org jnm.snmjournals.org/content/66/supplement_1/251138

Evaluation of [18F]PF974 as a PET Radiotracer for Imaging ... This study introduces [18 F]PF974, a novel PET radiotracer with high affinity and selectivity for PDE4B and evaluated its kinetic properties and reliability.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/22173840/

Effectiveness and safety of 18F-FDG PET in the evaluation ... These data support the role of (18)F-FDG PET as an effective and useful adjunct to other diagnostic information in the assessment of patients with symptoms of ...

8. alzdiscovery.org alzdiscovery.org/uploads/cognitive_vitality_media/CP2_UPDATE_%28drug_in_development%29.pdf

1 Last updated on May 17, 2024 Cognitive Vitality Reports ... Cognitive Vitality Reports® are reports written by neuroscientists at the Alzheimer's Drug. Discovery Foundation (ADDF).