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

25 août 2026 mis à jour par: 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.

Aperçu de l'étude

Type d'étude

Observationnel

Inscription (Estimé)

100

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

      • Hvidovre, Danemark, 2650
        • Recrutement
        • Danish Research Centre for Magnetic Resonance
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Oui

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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.

La description

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)

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

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

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Structural disintegraiton of the Locus Coeruleus
Délai: 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
Délai: Baseline
As with the Locus Coeruleus, it is expected to see altered neuromelanin signal from the SNc in RBD subjects compared to controls
Baseline

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Motor-task performance
Délai: 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
Délai: 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
Délai: 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.
Délai: Baseline
Loss of LC-CNR will positively correlate with increased burden of autonomic symptoms in RBD-subjects.
Baseline
Autonomic, sympathic responses to arousing stimuli
Délai: 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
Délai: 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

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Longitudinal outcomes
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 février 2026

Achèvement primaire (Estimé)

30 juin 2028

Achèvement de l'étude (Estimé)

31 décembre 2035

Dates d'inscription aux études

Première soumission

20 mars 2026

Première soumission répondant aux critères de contrôle qualité

25 août 2026

Première publication (Réel)

27 août 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

27 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

25 août 2026

Dernière vérification

1 mars 2026

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

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INDÉCIS

Description du régime IPD

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.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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