---
title: Accurately diagnose Lewy body dementia
nct_id: NCT06120049
phase: PHASE2, PHASE3
status: RECRUITING
sponsor: prof. dr. Koen Van Laere
study_type: INTERVENTIONAL
canonical_url: "https://parkinsonspathways.com/trial/NCT06120049"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06120049"
last_fetched: "2026-05-10T14:07:54.744Z"
source: "Parkinson's Pathways (curated)"
---
# Accurately diagnose Lewy body dementia

**Goal (in five words):** Accurately diagnose Lewy body dementia

**Official Title:** Prospective Head-to-head Comparison of Cardiac [18F]-MFBG PET Versus [123I]-MIBG SPECT in the Differentiation Between Parkinson's Disease and Multiple System Atrophy and Between Dementia With Lewy Bodies and Alzheimer's Disease

**Trial ID:** [NCT06120049](https://clinicaltrials.gov/study/NCT06120049)

## Key Facts

- **Phase:** PHASE2, PHASE3
- **Status:** RECRUITING
- **Study Type:** INTERVENTIONAL
- **Sponsor:** prof. dr. Koen Van Laere
- **Target Enrollment:** 113 participants
- **Start Date:** 2024-01-19
- **Completion Date:** 2026-07
- **Conditions:** Parkinson Disease, Dementia With Lewy Bodies, MSA - Multiple System Atrophy, Alzheimer Disease
- **Interventions:** [18F]-MFBG PET CT, [18F]-FE-PE2I PET CT or PET MRI, [123I]-MIBG SPECT CT, [18F]-MFBG PET dosimetry scans
- **Intervention Types:** DIAGNOSTIC_TEST

## Summary For Families

The goal is to see if a newer PET scan, cardiac [18F]-MFBG, can more accurately tell Parkinson's disease from multiple system atrophy, and dementia with Lewy bodies from Alzheimer's, by measuring how healthy the heart's sympathetic nerves are. The approach uses [18F]-MFBG PET to image the norepinephrine transporter in cardiac nerves, which gives more quantitative, higher-resolution data than standard [123I]-MIBG SPECT; participants also get brain DAT scans like [18F]-FE-PE2I to confirm dopaminergic loss, and dosimetry scans check radiation exposure. They are looking for adults 45 to 85 with clinically established PD or MSA-P, adults 50 to 85 with probable DLB or Alzheimer's, and healthy volunteers aged 18 to 85. Key requirements include the ability to give informed consent, prior abnormal DAT imaging for many patient groups, and no major heart disease or medications that interfere with the cardiac norepinephrine transporter or PET/MR scanning.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 85 Years
- **Sex:** ALL

### Full Criteria

```
Inclusion Criteria:

1. Healthy Controls:

   * Voluntary written informed consent.
   * Use of highly effective methods of birth control.
   * Age between 18 and 85 years.
   * Good health based on medical history, physical examination, clinical laboratory tests, and urinalysis.
   * No history or evidence of major neurological, internal, or psychiatric disorders.
   * Normal structural MRI scan for subjects \< 60 years or minor lesions for subjects \>= 60 years.
2. Parkinson's Disease:

   * Age 45-85 years.
   * Clinically established PD based on Movements Disorder Society diagnostic criteria.
   * Disease duration since onset of motor symptoms: 5 years or longer for one group and less than 5 years for another.
   * Previous abnormal \[18F\]-FE-PE2I PET or \[123I\]-FP-CIT SPECT scan.
   * Ability to understand the patient information brochure and provide written informed consent.
3. Multiple System Atrophy - Parkinsonian Variant:

   * Age 45-85 years.
   * Clinically established or clinically probable MSA-P based on MDS diagnostic criteria.
   * Previous abnormal \[18F\]-FE-PE2I PET or \[123I\]-FP-CIT SPECT scan.
   * Ability to understand the patient information brochure and provide written informed consent.
4. Dementia Due to Alzheimer's Disease:

   * Age 50-85 years.
   * Diagnosis of probable AD with evidence of the AD pathophysiological process.
   * Ability to understand the patient information brochure and provide written informed consent.
5. Dementia with Lewy Bodies:

   * Age 50-85 years.
   * Diagnosis of probable DLB.
   * Previous abnormal \[18F\]-FE-PE2I PET or \[123I\]-FP-CIT SPECT scan.
   * Ability to understand the patient information brochure and provide written informed consent.

Exclusion Criteria:

1. Healthy controls:

   * Major diseases that may interfere with the investigations.
   * Evidence of cognitive impairment.
   * History or evidence of psychiatric disease.
   * Use of illicit drugs or history of drug or alcohol abuse.
   * Chronic medication interfering with cardiac neuronal norepinephrine transporter (NET) or \[18F\]-FE-PE2I imaging.
   * Exposure to ionizing radiation \> 1 mSv in other research studies within the last 12 months.
   * Contraindication for MRI scanning.
   * Claustrophobia or inability to tolerate confinement during PET-MRI scanning.
   * Unwillingness to avoid strenuous physical activity.
   * Lack of understanding of the study procedures.
   * Pregnancy or breastfeeding.
   * Lack of agreement to communicate incidental findings to the general practitioner.
   * Abnormal Allen test or lidocaine hypersensitivity/allergy for subjects willing to undergo arterial sampling.
2. Parkinson's Disease:

   * Neuropsychiatric diseases other than PD.
   * Major internal medical comorbidity, especially diabetes or heart disease.
   * White matter lesion load on FLAIR Fazekas score 2 or higher or other relevant MRI abnormalities.
   * History of alcohol or drug abuse.
   * Previous participation in research studies involving ionizing radiation.
   * Contraindications for MR.
   * Claustrophobia or inability to tolerate confinement during PET scanning.
   * Unwillingness to avoid strenuous physical activity.
   * Lack of understanding of the study procedures.
   * Pregnancy or breastfeeding.
   * Lack of agreement to communicate incidental findings to the general practitioner.
   * Anticoagulant therapy.
3. Multiple System Atrophy - Parkinsonian Variant:

   * Same as for Parkinson's disease.
4. Dementia Due to Alzheimer's Disease:

   * Same as for Parkinson's disease.
5. Dementia with Lewy Bodies:

   * Same as for Parkinson's disease.
```

## Locations (2)

- UZ Ghent, Ghent, Gent, Belgium _(51.0500, 3.7167)_
  - Donatienne Van Weehaeghe, Dr. — (CONTACT) — +32 9 332 30 27 — donatienne.vanweehaeghe@uzgent.be
  - Donatienne Van Weehaeghe, Dr. — (PRINCIPAL_INVESTIGATOR)
  - Patrick Santens, Prof. dr. — (SUB_INVESTIGATOR)
  - Tim Van Langenhove, Dr. — (SUB_INVESTIGATOR)
- UZ Leuven, Leuven, Vlaams-Brabant, Belgium _(50.8796, 4.7009)_
  - Koen Van Laere, Prof. dr. — (CONTACT) — +3216343715 — koen.vanlaere@UZLeuven.be
  - Koen Van Laere, Prof. Dr. — (PRINCIPAL_INVESTIGATOR)
  - Wim Vandenberghe, Prof. Dr. — (SUB_INVESTIGATOR)
  - Aline Delva, Dr. — (SUB_INVESTIGATOR)
  - Louis Versweyveld, Dr. — (SUB_INVESTIGATOR)

## Central Contacts

- Koen Van Laere, Prof. dr. — (CONTACT) — +3216343715 — koen.vanlaere@UZLeuven.be

---

*Canonical: https://parkinsonspathways.com/trial/NCT06120049*  
*HTML version: https://parkinsonspathways.com/trial/NCT06120049*  
*Source data: https://clinicaltrials.gov/study/NCT06120049*