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

Sponsor
University of Aarhus
Study ID
NCT06745011
Status
Enrolling By Invitation

Conditions

  • Alpha-Synucleinopathy
  • Autonomic Failure
  • Cardiac Imaging
  • Lewy Body Dementia (LBD)
  • Lewy Body Disease
  • Multiple System Atrophy
  • Parkinson Disease (PD)
  • Polyneuropathy
  • REM Behavior Disorder
  • REM Sleep Behavior Disorder (iRBD)
  • Rapid Eye Movement Sleep Behavior Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

First listed
Dec 20, 2024
Start date
May 13, 2024
Status verified
Nov 2024
Primary completion
May 1, 2031
Completion
May 1, 2031

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: Idiopathic polyneuropathy with abnormal cardiac 123I-MIBG scintigraphy
    Participants diagnosed with polyneuropathy, orthostatic hypotension or non-nocturnal blood pressure dip and abnormal cardiac 123I-MIBG scintigraphy (cardiac sympathetic dysfunction)
  • Arm: Idiopathic polyneuropathy with normal cardiac 123I-MIBG scintigraphy
    Participants diagnosed with polyneuropathy, orthostatic hypotension or non-nocturnal blood pressure dip and normal cardiac 123I-MIBG scintigraphy

Primary Outcome Measure

Number of participants with REM sleep behavior disorder (RBD) [ Time Frame: RBD-status is assessed at two time point: Baseline (at the time of enrollment) and 5-year follow-up ]

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