---
title: Find tests predicting Parkinson progression
nct_id: NCT07533799
status: RECRUITING
sponsor: Skane University Hospital
study_type: OBSERVATIONAL
canonical_url: "https://parkinsonspathways.com/trial/NCT07533799"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07533799"
last_fetched: "2026-05-10T14:03:29.816Z"
source: "Parkinson's Pathways (curated)"
---
# Find tests predicting Parkinson progression

**Goal (in five words):** Find tests predicting Parkinson progression

**Official Title:** BioFINDER-Sleep: Idiopathic REM-sleep Behavior Disorder & Early Parkinson's Disease

**Trial ID:** [NCT07533799](https://clinicaltrials.gov/study/NCT07533799)

## Key Facts

- **Status:** RECRUITING
- **Study Type:** OBSERVATIONAL
- **Sponsor:** Skane University Hospital
- **Target Enrollment:** 650 participants
- **Start Date:** 2021-10-01
- **Completion Date:** 2033-06
- **Conditions:** Parkinson´s Disease, REM Sleep Behavior Disorder (iRBD), Lewy Body Disease, Synucleinopathy, Synucleinopathies
- **Interventions:** Dopamine transporter PET scan with [18F]FE-PE2I, Magnetic resonance imaging (MRI), [123I] MIBG scintigraphy of the heart, α-synuclein seeding amplification assays, Polysomnography, Smell test
- **Intervention Types:** DIAGNOSTIC_TEST

## Summary For Families

Goal: to find brain and body markers that show whether idiopathic REM sleep behavior disorder (iRBD) reflects early Lewy body disease and to track early Parkinson's progression. Approach: participants undergo dopamine transporter PET with [18F]FE-PE2I to measure loss of dopamine nerve endings, cardiac [123I]MIBG to test heart sympathetic denervation, MRI for brain structure, alpha-synuclein seeding amplification assays to detect misfolded alpha-synuclein, overnight polysomnography to confirm RBD, and smell testing; it is observational, so there is no experimental drug and it will not alter usual PD medications. Eligibility: ages 50 to 100, with groups for polysomnography-verified iRBD who do not meet PD criteria, early Parkinson's patients who are treatment naive or treated for up to 3 years, and healthy controls with no RBD or neurologic disease, all able to give consent and speak Swedish. Exclusions include major medical or psychiatric conditions, significant white matter disease, contraindications to MRI or PET, and for the PD group a normal dopamine transporter scan.

## Eligibility

- **Minimum age:** 50 Years
- **Maximum age:** 100 Years
- **Sex:** ALL

### Full Criteria

```
Inclusion Criteria:

Idiopathic RBD:

* Polysomnography verified RBD according to AASM criteria.
* Does not fulfill diagnostic criteria for idiopathic Parkinson´s disease.
* Age range 50-100. Women who are \<55 years of age will be required to take a pregnancy test before participation in the PET and scintigraphy part of the study if not post-menopausal.
* Ability to give informed consent.
* Speaks and understands Swedish to the extent that an interpreter is not necessary for the patient to fully understand the study information and cognitive tests.

Early Parkinson´s disease:

* Fulfills the diagnostic criteria for idiopathic Parkinson´s disease.
* The PD patients will be de novo (yet without any PD treatment) or with treatment for a maximum of 3 years.
* Age range 50-100. Women who are \<55 years of age will be required to take a pregnancy test before participation in the PET and scintigraphy part of the study if not post-menopausal.
* Ability to give informed consent.
* Speaks Swedish fluently as stated above. Healthy Controls
* Age range 50-100. Women who are \<55 years of age will be required to take a pregnancy test before participation in the PET and scintigraphy part of the study if not post-menopausal.
* No diagnosis of PD or another significant neurological disorder.
* No diagnosis of RBD.
* Ability to give informed consent.
* Speaks Swedish fluently as stated above.

Exclusion Criteria:

For all groups:

* Past history of severe or repeated concussive head injury or stroke or any significant systemic disease or unstable medical condition.
* History of severe and unstable depression, schizophrenia, schizoaffective disorder or bipolar disorder.
* Significant white matter microvascular disease.
* Contraindication to MRI and PET.

Exclusion criteria specific for early Parkinson´s disease:

* Normal dopamine transporter (\[18F\]FE-PE2I) scan.
```

## Locations (1)

- Skane University Hospital, Malmö, Sweden _(55.6059, 13.0007)_
  - Adjmal Nahimi, MD, PhD — (CONTACT) — +46 40 33 10 00 — adjmal.nahimi@med.lu.se
  - Erik Stomrud, MD, PhD — (CONTACT) — +46 40 33 10 00 — erik.stomrud@med.lu.se

## Central Contacts

- Erik Stomrud, MD, PhD — (CONTACT) — +46 40 33 10 00 — erik.stomrud@med.lu.se
- Adjmal Nahimi, MD, PhD — (CONTACT) — +46 40 33 10 00 — adjmal.nahimi@med.lu.se

---

*Canonical: https://parkinsonspathways.com/trial/NCT07533799*  
*HTML version: https://parkinsonspathways.com/trial/NCT07533799*  
*Source data: https://clinicaltrials.gov/study/NCT07533799*