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A Comprehensive, Multimodal Characterization of Prodromal PD in Subjects With RBD (7T-RBD)

25 augustus 2026 bijgewerkt door: Danish Research Centre for Magnetic Resonance

Comprehensive characterization of early-stage Parkinson's disease in patients with REM sleep behavior disorder

Parkinson's disease (PD) is the fastest-growing neurodegenerative disorder worldwide, significantly affecting quality of life and causing substantial social and economic burdens. Currently, treatments for Parkinson's disease primarily manage symptoms through medication and lifestyle changes but cannot stop disease progression. By the time Parkinson's disease is diagnosed, substantial nerve-cell loss has already occurred in specific brain areas. Identifying early signs of PD before symptoms fully develop is essential for improving future treatment strategies.

This research project aims to deeply understand the earliest stages of Parkinson's disease by studying patients with REM sleep behavior disorder (RBD). RBD is a condition characterized by unusual movements or behaviors during dream sleep, caused by nerve-cell loss in the brainstem. Importantly, more than 80% of individuals with RBD eventually develop Parkinson's disease or related conditions, such as Dementia with Lewy Bodies or Multiple System Atrophy.

Study Goals:

Our study will examine multiple potential biomarkers (measurable indicators) that could help identify early stages of Parkinson's disease. These include:

  1. Brain structure changes: The Investigators will use advanced imaging methods (7-Tesla MRI) to closely examine specific brain regions known to be affected early in Parkinson's disease, particularly the substantia nigra and the locus coeruleus (LC). The LC helps regulate sleep and wakefulness, and studies have shown it is damaged in patients with RBD and Parkinson's disease. Additionally, the investigators will use specialized imaging (Pe2i-PET and MIBG-scintigraphy) to measure dopamine availability and changes in heart nerve function.
  2. Abnormal protein buildup (ɑ-synuclein): In Parkinson's disease, nerve-cell death is linked to abnormal clumping of a protein called ɑ-synuclein within cells. Detecting this abnormal protein buildup early might help identify who is at risk of developing Parkinson's disease. The investigators aim to explore how levels of ɑ-synuclein aggregation relate to other early signs of the disease.
  3. Functional changes in brain and body: Polysomnography, an overnight sleep test recording brain (EEG) and heart (ECG) activity, is the best method for diagnosing RBD. The investigators will also measure brain activity during wakefulness to further understand early changes.
  4. Symptoms and physical tests: Participants will undergo thorough clinical assessments, including motor and cognitive tests, as well as tests evaluating autonomic (automatic nervous system) function, such as cardiovascular responses using a tilt-table test.

Together, these extensive assessments will provide a detailed understanding of how Parkinson's disease begins and progresses. This knowledge can greatly improve early diagnosis, allowing earlier and potentially more effective treatments for individuals at high risk.

Study Design:

The investigators will recruit:

  • 50 individuals diagnosed with REM sleep behavior disorder
  • 50 control participants without major psychiatric or neurological disease, matched by age and gender

THe investigation team have a complete, detailed plan and will begin collecting data as soon as ethical approval is granted.

Main Hypotheses:

Although our extensive data will allow many analyses, the investigation team specifically predict:

  • Individuals with RBD will show more significant damage in the locus coeruleus compared to controls.
  • Greater damage in the locus coeruleus will correlate with more severe cognitive issues, sleep problems, and autonomic dysfunction.
  • Cognitive issues in RBD patients might correlate with specific patterns of damage in different parts of the locus coeruleus. For example, memory problems might be linked to more damage in the front (rostral) part of this region.

Impact:

This study will significantly enhance early detection of Parkinson's disease, paving the way for personalized medical approaches and potentially more effective treatments. Conducted by a multidisciplinary team of experts in brain imaging, sleep medicine, autonomic function, and protein aggregation, this research supports Denmark's leadership in precision clinical imaging and aligns closely with hospital research strategies aimed at understanding and treating chronic diseases. Ultimately, our goal is to improve personalized patient care for Parkinson's disease in the future.

Studie Overzicht

Studietype

Observationeel

Inschrijving (Geschat)

100

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Ja

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

We have 2 groups; Subjects diagnosed with REM-sleep behaviour disorder via polysomnography Healthy, age- and gendermatched controls.

Our RBD-group will be recruited via an ongoing cohort at a different site (Danish center for sleep medicine), where subjects diagnosed with RBD via polysomnography will be asked to also participate in our cohort, should they fulfill our inclusion criteria.

Controls will be recruited via our own institutions webpage, as well as advertisements on other danish websites such as trialtree.dk.

Beschrijving

Inclusion Criteria:

Both groups - The ability to give informed consent

For RBD-group

  • Verified REM-sleep behaviour disorder via polysonography
  • No other significant neurological and psychiatric ilness

For Healthy controls

- Age matched to RBD-group

Exclusion Criteria:

  • Ferrous objects in or around the body
  • Pacemaker or other implanted electronic devices
  • Drug abuse unrelated to medication or alcohol abuse over a period of 6 months prior to the experiment
  • Other major immunological, cardiac, neurological or neuropsychiatric disorders
  • Claustrophobia
  • Incapability of giving informed consent
  • Unwillingness to be informed about abnormal findings.
  • Participation in clinical trials involving drug testing over a period of 6 months prior to the experiment.
  • Disease symptoms leading to excessive movement inside the scanner (e.g., excessive tremor)

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Control Participants
Control participants without known major psychiatric or neurological disease.
RBD-subjects
Subjects diagnosed with RBD via polysomnography.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Structural disintegraiton of the Locus Coeruleus
Tijdsspanne: Baseline
One of the main hypotheses is that there will be a strutural pattern of disintegration in the Locus Coeruleus (LC) in our RBD-cohort when compared to controls. This will be seen as a change in neuromelanin Contrast-to-Noise-Ratio (CNR) in the LC. We expect this pattern to have a caudo-rostral gradient, as other studies have shown in subjects with Parkinson's Disease.
Baseline
Differences in neuromelanin-CNR in the Substantia Nigra pars Compacta in RBD-subjects compared to controls
Tijdsspanne: Baseline
As with the Locus Coeruleus, it is expected to see altered neuromelanin signal from the SNc in RBD subjects compared to controls
Baseline

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Motor-task performance
Tijdsspanne: Baseline
The investigators expect to see group-level differences in motor-task performance with an in-house designed motor-test battery, validated before being put into use.
Baseline
Cognitive test performance
Tijdsspanne: Baseline
The investigators expect to see group-level differences in cognitive test performance, tested with particular tests from the CANTAB-battery, between RBD-subjects and controls, with controls performing better..
Baseline
Resting-state EEG
Tijdsspanne: Baseline

Preliminary data from another study (Manuscript under review) at our site has shown that the aperiodic part of resting-state EEG is able to clearly separate subjects with clinically established Parkinson's Disease from controls.

We will test whether this also holds true in the prodromal RBD-state using a short resting-state EEG recording.

Baseline
Correlation between LC and autonomic dysfunction.
Tijdsspanne: Baseline
Loss of LC-CNR will positively correlate with increased burden of autonomic symptoms in RBD-subjects.
Baseline
Autonomic, sympathic responses to arousing stimuli
Tijdsspanne: Baseline
Autonomic responses (Pupil dilation, skin conductance) to arousing stimuli will be changed in RBD-subjects compared to controls, correlating with lowered LC-CNR
Baseline
Cardiac sympathetic measures
Tijdsspanne: Baseline
Cardiac sympathetic nervous function, measures using MIBG-SPECT will be changed in RBD-subjects compared to controls, and correlate positively to the degree of cellular degeneration in the LC.
Baseline

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Longitudinal outcomes
Tijdsspanne: Through study completion, an average of 1 year
At follow up, subjects with more progressive cognitive deficits measured via MOCA and CANTAB are hypothesized to show more pronounced change in rostral LC-CNR.
Through study completion, an average of 1 year
Longitudinal outcomes
Tijdsspanne: Through study completion, an average of 1 year
Conversion rates to clinical ɑ-syn (PD, MSA, DLB) will be higher in subjects showing peripheral ɑ-synuclein pathology in blood and/or skin.
Through study completion, an average of 1 year
Longitudinal outcomes
Tijdsspanne: Through study completion, an average of 1 year
Subjects converting to DLB will display more rostral change in LC-CNR than subjects converting to other ɑ-syn.
Through study completion, an average of 1 year

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 februari 2026

Primaire voltooiing (Geschat)

30 juni 2028

Studie voltooiing (Geschat)

31 december 2035

Studieregistratiedata

Eerst ingediend

20 maart 2026

Eerst ingediend dat voldeed aan de QC-criteria

25 augustus 2026

Eerst geplaatst (Werkelijk)

27 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

27 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

25 augustus 2026

Laatst geverifieerd

1 maart 2026

Meer informatie

Termen gerelateerd aan deze studie

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

Beschrijving IPD-plan

The pseudonymized data can only be shared with a formal Data Processing Agreement and a formal approval by the Danish Data Protection agency in line with the requirements of the European General Data Protection Regulation. If complete anonymization can be achieved, individual data will be shared openly after study completion.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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