ClinicalTrials.gov record NCT06745011

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

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 7, 2026

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

StatusEnrolling by invitationThe study enrols only people the study team invites, for example patients already at a particular clinic. It is not open to the public.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
Age18 years old to 85 years old
SexAll
LocationDenmark
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This is a prospective observational study of people with idiopathic polyneuropathy plus abnormal blood-pressure responses who have had cardiac 123I‑MIBG testing. It measures how common REM sleep without atonia (RSWA) and isolated REM sleep behavior disorder (iRBD) are at baseline and whether participants develop iRBD, Parkinson disease, dementia with Lewy bodies, or multiple system atrophy over five years. The study also collects and stores skin, blood, cerebrospinal fluid, and stool for a research biobank.

What it is studying. At baseline, the study assesses how common RSWA and iRBD are in people with idiopathic polyneuropathy and compares those with abnormal versus normal cardiac 123I‑MIBG scintigraphy. Over five years it tests whether participants with abnormal cardiac 123I‑MIBG are more likely than those with normal MIBG to develop RSWA, iRBD, Parkinson disease, dementia with Lewy bodies, or multiple system atrophy. The study also collects biological samples to build a biobank for future biomarker research.

What the researchers hope to learn. Measure how common iRBD and RSWA are in people with idiopathic polyneuropathy, compare rates between those with abnormal and normal cardiac sympathetic innervation, track who develops PD, DLB, or MSA over five years, and create a biobank to search for prognostic biomarkers.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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.

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Show the detailed description from the registry

Primary aim (baseline): To assess the prevalence of isolated REM Sleep Behavior Disorder (iRBD) or REM sleep without atonia (RSWA) in patients with idiopathic polyneuropathy with as to without abnormal cardiac 123I-metaiodobenzylguanidine (MIBG) scintigraphy (assessment of cardiac sympathetic innervation) Secondary aim (baseline): To assess the prevalence of Parkinson's Disease (PD), Dementia with Lewy bodies (DLB) and Multiple System Atrophy (MSA) in patients with idiopathic polyneuropathy. Hypothesis (baseline): iRBD is more prevalent in patients known with idiopathic polyneuropathy and abnormal sympathetic innervation of the heart (assessed by cardiac 123I-MIBG scintigraphy) as compared to normal cardiac sympathetic innervation. Primary aim (5-follow-up): To assess whether patients with idiopathic polyneuropathy develop RSWA, iRBD, PD, DLB or MSA over a periode of five years. Hypothesis (5-follow-up): Patients known with idiopathic polyneuropathy and abnormal sympathetic innervation of the heart (assessed by cardiac 123I-MIBG scintigraphy) will convert to RSWA, iRBD, PD, DLB or MSA more often than those with normal cardiac sympathetic innervation. Methods: Clinical evaluation in combination with questionnaires, multi-modal imaging methods and polysomnography. (Assessment of neuropathy: Neuropathy Impairment Score - Lower Leg (NIS-LL), Utah Early Neurological Scale (UENS), Kumamoto Neurological Scale and autonomic function test including Tilt table Test, Valsalva Maneuver, Deep Breathing Test, The Quantitative sensory axon reflex test (QSART). Cognition: The Montreal Cognitive Assessment (MoCA), Trail making Test B (TMT-B). Motor function: MDS-Unified Parkinson's Disease Rating Scale part III (MDS-UPDRS-III). Multi-modal imaging: cardiac 123I-MIBG scintigraphy, PE2I-PET-CT, MR-neuromelanin. Sleep: REM Sleep Behavior Disorder Screening Questionnaire (RBDSQ), one-night video polysomnography (PSG).) Statistics: The researchers expect to enroll 100 participants with idiopathic polyneuropathy and orthostatic hypotension or abnormal 24-hour blood pressure measurement (non-nocturnal blood pressure dip) who have undergone cardiac 123I-MIBG scintigraphy. Based on preliminary results, the investigators expect that 1/3 (30 participants) will have abnormal cardiac MIBG scintigraphy (cases; suggested to have prodromal PD or DLB) and 2/3 (70 participants) with normal MIBG scintigraphy (controls). The prevalence of iRBD detected by video-PSG is assumed to be 5% in participants with normal cardiac MIBG scintigraphy and 35% in participants with abnormal MIBG scintigraphy. To achieve a power of 88%, 81 participants have to be included (54 with normal and 27 with abnormal cardiac MIBG scintigraphy). Power calculation was based on Fisher's exact-test. Fisher's exact test was used because of an expected small number of participants with video PSG-detected iRBD. Biobank: Simultaneously collection of body tissue/fluids: skin, blood, cerebrospinal fluid and faeces. Analysis of the levels of phosphorylated tau, total-tau and amyloid beta in cerebrospinal fluid is performed at baseline.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants undergo a clinical exam, questionnaires, motor and cognitive tests, autonomic function testing (for example tilt‑table and breathing tests), and one‑night video polysomnography (sleep study). They will have multi‑modal imaging (cardiac 123I‑MIBG scintigraphy, PE2I‑PET‑CT, MR neuromelanin as specified) and provide biological samples (skin, blood, cerebrospinal fluid, and faeces) for a biobank and biomarker analyses. Assessments occur at baseline and again at a 5‑year follow‑up. Some procedures (imaging and sample collection) can be invasive or time‑consuming.

How the study is structured. A prospective observational case-control study. Participants are grouped by abnormal versus normal cardiac 123I‑MIBG results. They have a baseline evaluation (clinical exams, questionnaires, multimodal imaging, one-night video polysomnography) and are reassessed after five years; biological samples are collected and stored.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The registry says participants are enrolled by invitation. Who decides who is invited, and how?
  • The listed sites are in Denmark. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on multiple system atrophy

Important dates

Study start
May 13, 2024
Primary completion
May 1, 2031 (estimated)
Study completion
May 1, 2031 (estimated)
Target enrollment
100 participants (estimated)
Last updated on registry
Jan 8, 2025
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
University of Aarhus
Collaborators
  • Aarhus University Hospital
  • Novo Nordisk A/S

Participating sites (1)

  • Institute of Clinical Medicine, Aarhus University

    Aarhus, Jutland, 8200 · Denmark

Terms used on this page · explanations by MedicalUpdates.ai

biobank
A collection of biological samples, such as blood or tissue, stored with medical information so that researchers can study them later.
biomarkers
Something measurable in the body, such as a blood test result or an imaging finding, that indicates how a condition or treatment is behaving.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
baseline
Measurements taken at the start of the study, before any study treatment, so that later results can be compared with them.
follow-up
The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
PET
A scan in which a small amount of a radioactive tracer is injected so that activity in tissues can be seen. Often combined with a CT or MRI scan.
CT
An X-ray scan that builds detailed cross-section images of the body. 'High-resolution' CT (HRCT) is used to look closely at the lungs.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

← Back to clinical trials