Ignite Creation Date:
2024-07-17 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06467461
Status:
RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-06-10
Brief Title:
Identification of Prodromal Neurodegeneration in Serotonergic-Induced REM Sleep Behavior Disorder
Sponsor:
University of Minnesota
Organization:
University of Minnesota
Study Overview
Official Title:
Identification of Prodromal Neurodegeneration in Serotonergic-Induced REM Sleep Behavior Disorder
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 coeruleussubcoeruleus 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None