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

NCT06467461 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-07-08

No results posted yet for this 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

  • Dementia With Lewy Bodies
  • Parkinson Disease
  • REM Sleep Behavior Disorder

Interventions

DIAGNOSTIC_TEST

Skin biopsy

Skin biopsy to detect systemic alpha-synuclein pathology in 5-HT RBD

DIAGNOSTIC_TEST

Speech testing

Speech Testing to quantify evolving signs of 5-HT RBD

DIAGNOSTIC_TEST

Ultra high field 7T MRI

7T MRI to examine 5-HT RBD for evidence of brainstem neurodegeneration

Sponsors & Collaborators

Principal Investigators

  • Michael Howell, MD · University of Minnesota

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-02-08
Primary Completion
2027-12-01
Completion
2028-09-01

Countries

  • United States

Study Locations

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Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06467461 on ClinicalTrials.gov