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

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
University of Minnesota
Study ID
NCT06467461
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • Skin biopsy — DIAGNOSTIC_TEST
    Skin biopsy to detect systemic alpha-synuclein pathology in 5-HT RBD
  • Speech testing — DIAGNOSTIC_TEST
    Speech Testing to quantify evolving signs of 5-HT RBD
  • Ultra high field 7T MRI — DIAGNOSTIC_TEST
    7T MRI to examine 5-HT RBD for evidence of brainstem neurodegeneration

Study Details

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.

Key Dates

Start date
Feb 8, 2024
Status verified
Jul 2025
Primary completion
Dec 1, 2027
Completion
Sep 1, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Other: Research participants
    Adults under the age of 75; who do not meet criteria for Parkinson's disease, dementia with Lewy bodies, Alzheimer's disease, other diagnosed neurodegenerative disorder, or other known cause of RBD; and have a history of or currently use the SSRIs of interest.

Primary Outcome Measure

Phosphorylated alpha synuclein deposits on skin biopsy [ Time Frame: time point 1 (baseline) and time point 2 (24 months, +/- 3 months) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MinnesotaMinneapolisMinnesota55455
Joy Schmidt

Find similar trials in Minneapolis, MN

By condition
Parkinson's disease
By specialty
NeurologyBrain disorders
By research site
University of Minnesota· Minneapolis, MN

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