NCT06467461Active, not recruiting
5-HT RBD REM Sleep Behavior Disorder
Identification of Prodromal Neurodegeneration in Serotonergic-Induced REM Sleep Behavior Disorder
Source: ClinicalTrials.gov · Last updated 10 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 66 (actual)
- First submitted
- 10 Jun 2024
- Start date
- 8 Feb 2024
- Primary completion date
- 1 Dec 2027
- Lead sponsor
- University of Minnesota
- Diseases
- Lewy body dementia, Parkinson disease
- NCT number
- NCT06467461
What you commit to
- Study type: Interventional
- Participants enrolled: 66
- From 8 Feb 2024 to the primary completion date, 1 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Meet criteria for Parkinson's disease, dementia with Lewy bodies, Multiple System Atrophy, Pure Autonomic Failure, Alzheimer's disease, other diagnosed neurodegenerative disorder, or other known cause of RBD (e.g. narcolepsy)
- History of dysarthria, aphasia or other condition which could interfere with speech assessment
- MRI exclusion criteria for 7T scans: presence of any metallic clip(s) or implantable medical devices (e.g., heart valve, aneurysm clip, coils or surgery, renal or aortic clips, shunts, stents or stent grafts, metal mesh/coil implants, neurostimulator, insulin pump, IVC filter, etc.).
- History of allergic response to xylocaine or other local anesthesia
- History of dream enactment that may suggest RBD
Age
- Younger than 18
- Older than 75
Other
- Serotonergic REM sleep behavior (5-HT RBD) participants
- Untreated obstructive sleep apnea, obesity hypoventilation, central sleep apnea or other sleep disordered breathing
- Reduced capacity to consent
- Pregnant women will be excluded due to unknown risk of MRI on developing fetus Control Participants
- Increased REM motor tone (REM atonia index \> 0.10) on PSG suggestive of RBD
Who the study is looking for
- Serotonergic REM sleep behavior (5-HT RBD) participants
- Diagnosis of polysomnogram-confirmed RBD with history of dream enactment or clear dream enactment visualized on video from polysomnogram.
- History of dream enactment began shortly after (less than 2 months) starting a serotonergic antidepressant medication. Control Participants
- Age (±3 years) and sex matched to participants with 5-HT RBD
- On serotonergic medication for at least 6 months without history of dream enactment.
- The following serotonergic medications will be included:
- Citalopram, Escitalopram, Fluoxetine, Fluvoxamine, Paroxetine, and Sertraline
Age in the registry: 18 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Minnesota Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.