In short
Clinical trials are investigating 1-[[(3S)-2,3-DIHYDRO-1,4-BENZODIOXIN-3-YL]METHYL]-4-[3-((11C)METHOXYMETHYL)-2-PYRIDINYL]PIPERAZINE in a neurology study. The trial aims to measure brain receptor availability with PET and MRI in older adults and people with Parkinson's disease, and to learn how aging affects this target.
Key points
- Clinical trials of 1-[[(3S)-2,3-DIHYDRO-1,4-BENZODIOXIN-3-YL]METHYL]-4-[3-((11C)METHOXYMETHYL)-2-PYRIDINYL]PIPERAZINE are studying brain imaging in neurology. The main trial is in Phase 2 and is authorised. It focuses on normal aging and Parkinson's disease. Researchers are measuring PET binding potential maps and MRI findings in the locus coeruleus. The planned enrollment is 165 participants.
Trial overview
The available trial is NA2C-TEP-IRM, which is listed as an interventional study in neurology.1 It is authorised and planned to enroll 165 people.1
The study uses the radiotracer [¹¹C]ORM-13070 to evaluate the effect of normal aging and Parkinson's disease on the availability of α₂C-adrenergic receptors in the human brain.1
Who is being studied
The brief summary says the study is focused on normal aging and Parkinson's disease.1 The trial data do not give full participation rules, but they show that the target population includes people relevant to these two neurology groups.1
Because the study is about brain imaging, participants are being assessed with PET and MRI scans rather than with a treatment plan for symptom control.1
Study design and phase
This is a Phase 2 trial.1 Phase 2 studies are usually used to look more closely at a research question in a defined group after earlier work has already started the testing process.
The trial is interventional, which means the research team gives the study product and then measures the results.1 In this study, the intervention is listed as a drug injection of [11C]ORM-13070 at 350 MBq.1
What is being measured
The primary outcome uses PET data to calculate binding potential (BPND) parametric maps with compartmental modelling techniques.1 In simple terms, this means the scan data are turned into maps that help researchers estimate how strongly the tracer is associated with the target in the brain.1
The MRI outcome measures the locus coeruleus, a small brain region, using a neuromelanin-sensitive MRI sequence and then calculates signal intensity for each participant.1 Neuromelanin-sensitive MRI means a scan method designed to highlight a natural brain pigment linked with certain nerve cells.1
Together, these outcomes are meant to compare how aging and Parkinson's disease may change receptor availability and related brain signals.1
Why this study matters
This trial is not described as a treatment study for symptoms; instead, it is a research study about brain biology in people with and without Parkinson's disease.1 The results may help researchers better understand how the noradrenergic system changes with age and disease, based on the trial's stated objective.1
Only one trial record was provided, so the overall clinical trial picture for 1-[[(3S)-2,3-DIHYDRO-1,4-BENZODIOXIN-3-YL]METHYL]-4-[3-((11C)METHOXYMETHYL)-2-PYRIDINYL]PIPERAZINE is limited to this Phase 2 neurology imaging study.1