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NCT06467461 · ClinicalTrials.gov registry record · NA

Identification of Prodromal Neurodegeneration in Serotonergic-Induced REM Sleep Behavior Disorder

A NA study of Parkinson Disease and Dementia With Lewy Bodies, sponsored by University of Minnesota.

Recruiting
Registry status
NA
Development phase
60
Enrollment target
1
Study location

NCT06467461 is a NA study of Parkinson Disease and Dementia With Lewy Bodies that is actively recruiting participants, run by University of Minnesota. The registered enrollment target is 60 participants, below the 5,326-participant average among 297 other Parkinson Disease trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT06467461, a NA study of Parkinson Disease and Dementia With Lewy Bodies, is actively recruiting participants, sponsored by University of Minnesota.

RECRUITING
Registry status
NA
Development phase
60 participants
Enrollment target
1
Study location

Study Summary

This project will test the hypotheses that people with 5-HT RBD have systemic alpha- synuclein pathology, prodromal DLB signs, and brainstem lesions in regions that control REM sleep. AIM 1 will seek to detect abnormally phosphorylated alpha- synuclein aggregates on targeted skin biopsy in a cohort of people with 5-HT RBD and matched controls (taking SSRIs but without RBD). Aim 2 will use ultra-high field MRI at 7T to examine the pontine region of the coeruleus/subcoeruleus complex for evidence of neurodegeneration as well as segment and parcellate REM sleep related neuronal structures. Aim 3 will test for speech deficits. While these aims are independent we suspect that the severity of autonomic, speech and cognitive deficits will correlate with loss of neuromelanin signal on MRI and pathology on skin biopsy. The investigation is a longitudinal designed study to examine histopathology, neuroimaging changes and speech function from baseline (Time 1) to a follow-up after 30 months (Time 2). A total of 60 individuals, 30 with 5-HT RBD and 30 controls, will be recruited at Time 1, brought back at Time 2, and tested across all Aims at both study visits.

Conditions Studied

Parkinson Disease Dementia With Lewy Bodies REM Sleep Behavior Disorder

Interventions

  • DIAGNOSTIC_TEST Skin biopsy
  • DIAGNOSTIC_TEST Speech testing
  • DIAGNOSTIC_TEST Ultra high field 7T MRI

Study Locations (1)

Minnesota

  • University of Minnesota - Minneapolis

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2024-02-08
Est. Completion 2028-09-01
Phase NA

Sponsor

University of Minnesota

966 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06467461

The ClinicalTrials.gov registry entry for NCT06467461 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 5,326-participant average among 297 other Parkinson Disease trials with a reported enrollment target (99% lower). The listed sponsor is University of Minnesota, which has 966 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Parkinson Disease appearing as the primary indexed condition, and to 3 interventions - of which Skin biopsy is the first listed.

NCT06467461 reports 1 study location spanning 1 distinct geographic area - top geographies include Minnesota.

Frequently Asked Questions

What is clinical trial NCT06467461 about?

NCT06467461 is a clinical study titled "Identification of Prodromal Neurodegeneration in Serotonergic-Induced REM Sleep Behavior Disorder". This project will test the hypotheses that people with 5-HT RBD have systemic alpha- synuclein pathology, prodromal DLB signs, and brainstem lesions in regions that control REM sleep. AIM 1 will seek to detect abnormally phosphorylated alpha- synuclein aggregates on targeted skin biopsy in a cohort ...

What is the current status of trial NCT06467461?

This trial is currently recruiting. It is a NA study. The enrollment target is 60 participants. The study started on 2024-02-08. Estimated completion is 2028-09-01.

What conditions does trial NCT06467461 study?

This clinical trial studies the following conditions: Parkinson Disease, Dementia With Lewy Bodies, REM Sleep Behavior Disorder.

What interventions are being tested in trial NCT06467461?

The interventions under investigation include: Skin biopsy (DIAGNOSTIC_TEST), Speech testing (DIAGNOSTIC_TEST), Ultra high field 7T MRI (DIAGNOSTIC_TEST).

Who is sponsoring clinical trial NCT06467461?

This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06467461 being conducted?

This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.