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4-Fluoro-N-[2-[4-(2-Methoxyphenyl)Piperazin-1-Yl]Ethyl]-N-Pyridin-2-Ylbenzamide

This article discusses a clinical trial investigating the use of [18F]-MPPF, a radioactive tracer, in positron emission tomography (PET) imaging to study pain in Parkinson’s disease (PD). The trial aims to explore the serotonin system’s role in pain experienced by PD patients and compare brain activity between those with and without pain. This research could lead to a better understanding of pain mechanisms in Parkinson’s disease and potentially improve treatment strategies.

Table of Contents

What is 18F-MPPF?

18F-MPPF is a radioactive substance used in medical research, specifically for studying Parkinson’s disease (PD) and pain associated with it. Its full chemical name is 4-fluoro-N-[2-[4-(2-methoxyphenyl)piperazin-1-yl]ethyl]-N-pyridin-2-ylbenzamide. This compound is not a medication, but rather a tool used in brain imaging studies.[1]

Purpose of the Study

Researchers are using 18F-MPPF to better understand how pain works in Parkinson’s disease. The main goal is to explore the role of the brain’s serotonin system in PD-related pain. This study compares Parkinson’s patients who experience pain with those who don’t, to see if there are differences in how their brains process pain signals.[1]

How 18F-MPPF Works

18F-MPPF is injected into the bloodstream and travels to the brain. It’s designed to attach to specific receptors in the brain called serotonin 1A receptors. These receptors are involved in pain processing and mood regulation. By using a special imaging technique called Positron Emission Tomography (PET), doctors can see where 18F-MPPF accumulates in the brain, giving them information about the serotonin system’s activity.[1]

Eligibility Criteria

To participate in this study, patients must meet certain criteria:

  • Have Parkinson’s disease diagnosed according to specific medical criteria
  • Be between 40 and 80 years old
  • Have stable Parkinson’s medication for at least 4 weeks
  • Score above 25 on a cognitive test called MOCA (Montreal Cognitive Assessment)
  • Not have severe depression (score 11 or less on a depression scale called HADS-D)

Some factors that would prevent participation include:

  • Having had deep brain stimulation or using medication pumps for Parkinson’s
  • Significant psychiatric history
  • Using certain antidepressants in the past 4 weeks
  • Being unable to have an MRI scan
  • Pregnancy or breastfeeding

These criteria help ensure the safety of participants and the reliability of the study results.[1]

Study Objectives

The main objectives of this research are:

  1. To measure and compare the distribution of 18F-MPPF in the brains of Parkinson’s patients with and without pain
  2. To understand how 18F-MPPF uptake relates to pain intensity and characteristics in patients who experience pain
  3. To examine how pain perception thresholds differ between the two groups
  4. To compare pain-related brain networks using functional MRI
  5. To investigate how brain structure relates to pain experiences in Parkinson’s disease

These objectives aim to provide a comprehensive understanding of pain mechanisms in Parkinson’s disease.[1]

Potential Benefits

While this study doesn’t directly treat pain, it could lead to significant advancements in understanding and treating pain in Parkinson’s disease. By learning more about how the serotonin system is involved in pain processing, researchers may be able to develop new treatments or improve existing ones for Parkinson’s patients suffering from pain.[1]

Safety Considerations

18F-MPPF is given as an intravenous injection, meaning it’s injected directly into a vein. The maximum dose used in this study is 220 MBq/kg (megabecquerels per kilogram). This is a measure of radioactivity, not weight. The exposure to radiation is carefully controlled and monitored to ensure participant safety.

It’s important to note that this compound is used for research purposes only and is not a treatment. Participants will also undergo MRI scans, which do not involve radiation but require lying still in a confined space for some time.[1]

Aspect Details
Study Drug [18F]-MPPF (4-Fluoro-N-[2-[4-(2-Methoxyphenyl)Piperazin-1-Yl]Ethyl]-N-Pyridin-2-Ylbenzamide)
Primary Objective Measure [18F]-MPPF distribution in the brain of Parkinson’s disease patients with and without pain
Secondary Objectives Assess relationship between [18F]-MPPF uptake and pain characteristics, compare pain-related functional networks, evaluate links between brain structure and pain parameters
Participant Age Range 40-80 years
Key Inclusion Criteria Parkinson’s disease diagnosis, stable anti-parkinsonian treatment, MOCA score > 25, HADS-D score ≤ 11
Key Exclusion Criteria Second-line therapy for PD, significant psychiatric history, contraindications to MRI, disabling dyskinesias
Imaging Techniques PET with [18F]-MPPF, MRI (structural and functional)
Maximum Dose 220 MBq/kg
Administration Route Intravenous

FAQ

  • What is the main goal of this clinical trial? The main goal is to measure and compare the distribution of [18F]-MPPF in the brains of Parkinson's disease patients with and without pain using PET imaging. This will help researchers understand the role of the serotonin system in pain experienced by PD patients.
  • Who can participate in this study? Participants must be men and women aged 40-80 years with Parkinson's disease, stable anti-parkinsonian treatment for at least 4 weeks, a MOCA score > 25, and a HADS-D score ≤ 11. They must also be able to provide informed consent and meet other specific criteria.
  • What does the [18F]-MPPF drug do? The [18F]-MPPF is a radioactive tracer used in PET imaging. It binds to serotonin receptors in the brain, allowing researchers to visualize and measure serotonin system activity, which may be related to pain perception in Parkinson's disease patients.
  • Are there any risks associated with participating in this trial? While the trial information doesn't explicitly state risks, participants will undergo PET imaging and MRI scans. These procedures involve exposure to radiation and magnetic fields, respectively. The researchers will ensure that proper safety measures are in place, and participants are screened for any contraindications to these imaging techniques.
  • What other assessments will be done besides PET imaging? In addition to PET imaging, participants will undergo MRI scans to assess brain structure and function. The study will also evaluate pain intensity, pain characteristics, pain-induced functional discomfort, and pain perception thresholds. Researchers will analyze the relationship between these factors and the [18F]-MPPF uptake in the brain.

Ongoing Clinical Trials on 4-Fluoro-N-[2-[4-(2-Methoxyphenyl)Piperazin-1-Yl]Ethyl]-N-Pyridin-2-Ylbenzamide

  • A study using MPPF imaging to examine serotonin pathways in the brainstem of patients with Dravet Syndrome epilepsy

    Recruiting

    2 1 1
    Investigated drugs:
    France

  • Study on Pain in Parkinson’s Disease: Examining the Effects of 18F-MPPF in Patients with and without Pain

    Recruiting

    2 1 1
    Investigated drugs:
    France

Glossary

  • Parkinson's disease (PD): A progressive neurological disorder that affects movement, balance, and coordination. It is caused by the loss of dopamine-producing brain cells.
  • Positron Emission Tomography (PET): An imaging technique that uses radioactive tracers to visualize and measure activity in the body's tissues and organs, particularly useful for studying brain function.
  • [18F]-MPPF: A radioactive tracer used in PET imaging that binds to serotonin receptors in the brain, allowing researchers to study the serotonin system's activity.
  • Serotonin: A neurotransmitter that plays a role in mood regulation, pain perception, and various other bodily functions.
  • Distribution Volume Ratio (DVR): A measure used in PET imaging to quantify the distribution of a radioactive tracer in different brain regions relative to a reference region.
  • MOCA score: Montreal Cognitive Assessment score, a screening tool used to assess cognitive function.
  • HADS-D score: Hospital Anxiety and Depression Scale – Depression subscale score, used to assess depression symptoms.
  • Resting-state functional MRI: A type of MRI that measures brain activity while a person is at rest, used to study functional networks in the brain.
  • Dyskinesia: Abnormal, uncontrolled, involuntary movements often associated with long-term use of certain Parkinson's disease medications.
  • UKPDSBB criteria: United Kingdom Parkinson's Disease Society Brain Bank clinical diagnostic criteria, a set of guidelines used to diagnose Parkinson's disease.

References

  1. http://clinicaltrials.eu/trial/study-on-pain-in-parkinsons-disease-examining-the-effects-of-18f-mppf-in-patients-with-and-without-pain/