NCT06467461 Identification of Prodromal Neurodegeneration in Serotonergic-Induced REM Sleep Behavior Disorder
| NCT ID | NCT06467461 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Minnesota |
| Condition | Dementia With Lewy Bodies |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-02-08 |
| Primary Completion | 2027-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2024-02-08 with a primary completion date of 2027-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
Inclusion Criteria: Serotonergic REM sleep behavior (5-HT RBD) participants Inclusion Criteria: * 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 Inclusion Criteria: * 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 Exclusion Criteria: Serotonergic REM sleep behavior (5-HT RBD) participants Exclusion Criteria: * Younger than 18 * Older than 75 * 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) * Untreated obstructive sleep apnea, obesity hypoventilation, central sleep apnea or other sleep disordered breathing * History of dysarthria, aphasia or other condition which could interfere with speech assessment * Reduced capacity to consent * 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 * Pregnant women will be excluded due to unknown risk of MRI on developing fetus Control Participants Exclusion Criteria: same exclusion criteria as 5-HT RBD group, plus the following: * History of dream enactment that may suggest RBD * Increased REM motor tone (REM atonia index \> 0.10) on PSG suggestive of RBD
Contact & Investigator
Michael Howell, MD
PRINCIPAL INVESTIGATOR
University of Minnesota
Frequently Asked Questions
Who can join the NCT06467461 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Dementia With Lewy Bodies. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06467461 currently recruiting?
Yes, NCT06467461 is actively recruiting participants. Contact the research team at schmidtj@umn.edu for enrollment information.
Where is the NCT06467461 trial being conducted?
This trial is being conducted at Minneapolis, United States.
Who is sponsoring the NCT06467461 clinical trial?
NCT06467461 is sponsored by University of Minnesota. The principal investigator is Michael Howell, MD at University of Minnesota. The trial plans to enroll 60 participants.