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

NCT06745011 | Enrolling By Invitation

• 2 other identifiers: 1-10-72-20-24NNF230C0082689
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Isolated Rapid Eye Movement Sleep Behavior Disorder; REM Sleep Behavior Disorder; Polyneuropathy; Idiopathic Polyneuropathy; Cardiac MIBG Scintigraphy; Prodromal Lewy Body Disease; Lewy Body Disease; Alpha-synucleinopathy

Outcome Measures

Primary Outcomes (1)

• Number of participants with REM sleep behavior disorder (RBD)

  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.

  RBD-status is assessed at two time point: Baseline (at the time of enrollment) and 5-year follow-up

Secondary Outcomes (1)

• Number of participants with Parkinson's Disease (PD) or related alpha-synucleinopathies (Dementia with Lewy bodies (DLB), Multiple System atrophy (MSA)), REM-Sleep without atonia (RSWA)

  Assessed at baseline (at the time of enrollment) and at 5-year follow-up

Study Arms (2)

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)

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

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with definite polyneuropathy (confirmed by nerve conductions study) diagnosed in Jutland, Denmark and orthostatic hypotension or non-nocturnal blood pressure reduction.

You may qualify if:

• Definite polyneuropathy without known etiology (idiopathic) AND orthostatic hypotension (active stand test) OR non-nocturnal blood pressure reduction (24 hour blood pressure measurement)

You may not qualify if:

• Known etiology of polyneuropathy
• A diagnosis of either dementia, Parkinson's disease, Dementia with Lewy Bodies or Multiple System Atrophy.

Sponsors & Collaborators

• University of Aarhus: lead
• Aarhus University Hospital: collaborator
• Novo Nordisk A/S: collaborator

Study Sites (1)

Institute of Clinical Medicine, Aarhus University

Aarhus, Jutland, 8200, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood, cerebrospinal fluid, skin, faeces.

MeSH Terms

Conditions

Polyneuropathies; Synucleinopathies; Lewy Body Disease; Parkinson Disease; Multiple System Atrophy; Pure Autonomic Failure; REM Sleep Behavior Disorder

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurodegenerative Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Dementia; Movement Disorders; Neurocognitive Disorders; Mental Disorders; Primary Dysautonomias; Autonomic Nervous System Diseases; REM Sleep Parasomnias; Parasomnias; Sleep Wake Disorders

Study Officials

• Astrid J. Terkelsen, MD, DrMedSc, PhD, Professor

  Department of clinical medicine, Aarhus University and Department of Neurology, Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: December 20, 2024
• Study Start: May 13, 2024
• Primary Completion (Estimated): May 1, 2031
• Study Completion (Estimated): May 1, 2031
• Last Updated: January 8, 2025

Record last verified: 2024-11

Locations

DK (1)