Identifying early signs of neurodegeneration in patients with REM sleep behavior disorder
Identification of Prodromal Neurodegeneration in Serotonergic-Induced REM Sleep Behavior Disorder
This study is trying to see if people with REM sleep behavior disorder show early signs of brain changes and dementia by looking at skin samples, brain scans, and speech tests over two and a half years.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University of Minnesota Academic / other |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT06467461 on ClinicalTrials.gov |
What this trial studies
This project aims to investigate the presence of systemic alpha-synuclein pathology and early signs of dementia in individuals diagnosed with serotonergic-induced REM sleep behavior disorder (5-HT RBD). The study will involve skin biopsies to detect abnormal protein aggregates, ultra-high field MRI scans to assess neurodegeneration in specific brain regions, and speech testing to evaluate cognitive function. Participants will be followed over a 30-month period to correlate clinical symptoms with neuroimaging and histopathological findings.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with polysomnogram-confirmed REM sleep behavior disorder who have recently started serotonergic antidepressant medications.
Not a fit: Patients with established neurodegenerative diseases such as Parkinson's disease or dementia with Lewy bodies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier diagnosis and intervention strategies for neurodegenerative diseases associated with REM sleep behavior disorder.
How similar studies have performed: While the specific approach of this study is novel, similar studies have shown promise in identifying early neurodegenerative changes in related conditions.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Minneapolis, Minnesota
- University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Michael Howell, MD — University of Minnesota
- Study coordinator: Joy Schmidt
- Email: schmidtj@umn.edu
- Phone: (612) 624 -1456
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.