Table of Contents
- Trial overview
- Who is being studied
- Study design and phase
- What is being measured
- Why this study matters
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]
