---
title: Distinguish Parkinson from related disorders
nct_id: NCT07509125
phase: NA
status: RECRUITING
sponsor: Universitaire Ziekenhuizen KU Leuven
study_type: INTERVENTIONAL
canonical_url: "https://parkinsonspathways.com/trial/NCT07509125"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07509125"
last_fetched: "2026-05-10T14:07:55.416Z"
source: "Parkinson's Pathways (curated)"
---
# Distinguish Parkinson from related disorders

**Goal (in five words):** Distinguish Parkinson from related disorders

**Official Title:** Ultra-High Resolution PET of the Human Brain and Spinal Cord in Healthy Aging, Dementia, Movement Disorders, ALS and Psychotic Disorders

**Trial ID:** [NCT07509125](https://clinicaltrials.gov/study/NCT07509125)

## Key Facts

- **Phase:** NA
- **Status:** RECRUITING
- **Study Type:** INTERVENTIONAL
- **Sponsor:** Universitaire Ziekenhuizen KU Leuven
- **Target Enrollment:** 300 participants
- **Start Date:** 2026-02-13
- **Completion Date:** 2029-09
- **Conditions:** Alzheimer Dementia (AD), ALS - Amyotrophic Lateral Sclerosis, Parkinson s Disease, REM Sleep Behavior Disorder (iRBD), PSP - Progressive Supranuclear Palsy, MSA - Multiple System Atrophy, Dementia With Lewy Bodies (DLB), ALS With Frontotemporal Dementia (ALS/FTD), Adult Onset Psychotic Disorder, Very Late Onset Psychotic Disorder
- **Interventions:** UHR PET/CT scan of the brain with ¹⁸F-FDG, UHR PET/CT scan of the brain with ¹⁸F-PE2I, UHR PET/CT scan of the brain with ¹⁸F-SynVesT-1, UHR PET/CT scan of the brain with ¹⁸F-MK6240, 3T MRI imaging of the brain
- **Intervention Types:** OTHER

## Summary For Families

The goal is to create ultra-high resolution maps of metabolism, dopamine terminals, synapses and tau in the brain and spinal cord, so clinicians can better tell Parkinson's and related disorders apart and spot early changes. Participants get PET scans with 18F-FDG to measure glucose use, 18F-PE2I to image dopamine transporters and reveal nigrostriatal nerve terminal loss, 18F-SynVesT-1 to quantify synaptic density, and 18F-MK6240 to detect tau, plus a 3T MRI; these are diagnostic imaging tests, they do not treat symptoms and do not interact with levodopa. The study enrolls healthy adults and people with a range of conditions, including Parkinson's, dementia syndromes, ALS, movement disorders, REM sleep behavior disorder and psychosis. For Parkinson's specifically, adults aged 18 to 90 with clinically established PD by MDS criteria, an abnormal 18F-PE2I PET, and no significant cognitive impairment (MoCA 26 or higher) who can tolerate PET/MRI are eligible.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 90 Years
- **Sex:** ALL

### Full Criteria

```
Inclusion Criteria:

* WP1: Healthy controls
* Age between 18 and 90 years old (15 aged 18-50 years and 25 aged 50 90 years);
* Subject is judged to be in good health by the investigator on the basis of medical history, physical examination including vital signs and clinical laboratory tests;
* No history or evidence of current major neurological, internal or psychiatric disorder, based on the medical assessment as described hereabove and neuropsychological assessment;
* No evidence of cognitive impairment as assessed by a Montreal Cognitive Assessment (MoCA) score of 26 or higher at baseline;
* In subjects \< 60 years of age, a normal structural MRI scan as assessed by expert radiologist.
* In subjects \>= 60 years of age white matter hyperintensities corresponding to a WML (white matter lesion) score \<= 2 (of 3) on the Age-Related White Matter changes scale are acceptable;
* When older than 50 years of age, the volunteer is willing to undergo a p- tau217 blood sample.
* WP2: Dementia
* Patient has a clinical diagnosis of biomarker-proven prodromal AD
* WP3: ALS spectrum
* Subject must meet El Escorial Criteria (30) and Awaji-Shima criteria (31) for at least possible ALS;
* WP4: Movement disorders
* (all): Patient (or legal representative, when applicable) is able to understand the patient information form and give written informed consent.
* Parkinson´s disease (PD):
* Patient has clinically established PD based on the Movement Disorder Society (MDS) diagnostic criteria (32);
* Patient has an abnormal 18F-PE2I PET;
* No evidence of cognitive impairment as assessed by a Montreal Cognitive Assessment (MoCA) score of 26 or higher at baseline.
* Multiple system atrophy (MSA)
* Patient has clinically established or clinically probable MSA-P based on the
* Movement Disorder Society (MDS) diagnostic criteria (33);
* Patient has an abnormal 18F-PE2I PET.
* Progressive supranuclear palsy (PSP)
* Patient has an abnormal 18F-PE2I PET;
* Patient has clinically established probable PSP according to the latest MDS criteria
* Dementia with Lewy bodies (DLB)
* Patient has probable DLB by consensus criteria (cognitive impairment MoCA \< 26 + visual hallucinations and/or fluctuating alertness);
* Patient has an abnormal 18F-PE2I PET.
* Idiopathic REM sleep behavior disorder (iRBD)
* Patient has Polysomnography-confirmed iRBD;
* No evidence of cognitive impairment as assessed by a Montreal Cognitive Assessment (MoCA) score of 26 or higher at baseline;
* No clinical evidence of parkinsonism at baseline.
* WP5: Psychosis
* DSM 5 criteria for a non-affective schizophrenia spectrum psychotic disorder;
* Age between 18 and 55 years old for adult-onset psychosis, onset of psychosis (and age) above 60 years old for very late onset psychosis.

Exclusion Criteria:

* Subject has a history of any major (other) internal, psychiatric or neurological disease that may interfere with the investigations (especially liver and kidney disease, uncontrolled diabetes, cancer, severe depression, stroke, severe TBI);
* Subject is currently a user (including recreational use) of any illicit drugs, including cannabis, or has a history of drug or alcohol abuse;
* Subject chronically uses medication that has central nervous system effects (e.g. strong painkillers such as opioids, neuroleptics,..; ) (other than prescribed for the illness in case of patients);
* Subject has had exposure to ionizing radiation (\> 1 mSv) in other research studies within the last 12 months;
* Subject has a contra-indication for MRI scanning;
* Subject suffers from claustrophobia or cannot tolerate confinement during PET-MRI scanning procedures; subject cannot lie still for (at least) 60 minutes inside the scanner;
* (For subjects with arterial sampling): The subject is hypersensitive to lidocaine (used for local anaesthesia during the placement of the arterial catheter), has an abnormal Allen test (a test to check blood flow in the arteries of the forearm) or is on anti-coagulant therapy;
* Subject (or his/her legal representative) does not understand the study procedures;
* Subject is unwilling or unable to perform all of the study procedures, or is considered unsuitable in any way by the principal investigator;
* Subject is potentially pregnant (hCG test can be done if doubt exists).
```

## Locations (1)

- UZ Leuven, Leuven, Vlaams-Brabant, Belgium _(50.8796, 4.7009)_
  - Koen Van Laere, Prof. Dr. — (CONTACT) — +32 16 34 37 11 — koen.vanlaere@uzleuven.be

## Central Contacts

- Koen Van Laere, Prof. Dr. — (CONTACT) — +32 16 34 37 11 — koen.vanlaere@uzleuven.be
- Francine Reniers — (CONTACT) — +32 16 34 37 15 — francine.reniers@uzleuven.be

---

*Canonical: https://parkinsonspathways.com/trial/NCT07509125*  
*HTML version: https://parkinsonspathways.com/trial/NCT07509125*  
*Source data: https://clinicaltrials.gov/study/NCT07509125*