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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: Recruiting NA study of Parkinson Disease and Dementia With Lewy Bodies, sponsored by University of Minnesota.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Incidence (positive or negative) of phosphorylated alpha synuclein deposits. Indicating direct histopathological confirmation of underlying alpha-synuclein degeneration in 5-HT RBD in a cohort of people with 5-HT RBD and matched controls (taking SSRIs but without RBD).
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2024-02-08 |
| Est. Completion | 2028-09-01 |
| Phase | NA |
What NCT06467461 shows while recruiting
NCT06467461 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 5,326-participant average among 297 other Parkinson Disease trials with a reported enrollment target (99% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT06467461's enrollment target sits among peer trials
60 125th of 297 higher than 154 of 297 other Parkinson Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Parkinson Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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