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Enrolling by invitation Observational

Prodromal Model of Parkinson's Disease Confined to The Peripheral Nervous System

NCT06745011 · tracked via the Priya Life Science Denmark tracker
Phase
Observational
Started
2024-05-13
Last updated
2025-01-08

Condition(s) studied

PolyneuropathyAlpha-SynucleinopathyLewy Body DiseaseParkinson Disease (PD)Lewy Body Dementia (LBD)Multiple System AtrophyAutonomic FailureCardiac ImagingRapid Eye Movement Sleep Behavior DisorderREM Sleep Behavior Disorder (iRBD)REM Behavior Disorder

Study summary

Description of a method to detect Parkinson's disease or Parkinson's-like disease at an early stage (Prodromal Parkinson's Disease) where damage is still confined to the peripheral nervous system damage. Simultaneous collection of biological material to establish a biobank for use as prognostic biomarkers for the development of Parkinson's disease and other neurodegenerative diseases in which pathological alpha-synuclein deposits accumulate.

Eligibility

Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria: * Definite polyneuropathy without known etiology (idiopathic) AND orthostatic hypotension (active stand test) OR non-nocturnal blood pressure reduction (24 hour blood pressure measurement) Exclusion Criteria: * Known etiology of polyneuropathy * A diagnosis of either dementia, Parkinson's disease, Dementia with Lewy Bodies or Multiple System Atrophy.

Primary outcome measure(s)

  • Number of participants with REM sleep behavior disorder (RBD) — RBD-status is assessed at two time point: Baseline (at the time of enrollment) and 5-year follow-up
    RBD-status will be assessed by one-night video-polysomnography and REM Sleep Behavior Disorder Screening questionnaire (RBDSQ). Diagnosis of RBD according to American Academy of Sleep Medicine (AASM) criteria.

Trial sites (1)

FacilityCityRegionStatus
Institute of Clinical Medicine, Aarhus University Aarhus Jutland
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06745011 on ClinicalTrials.gov ↗ ← All trials in Denmark