Neurodegeneration Identification for REM Sleep Behavior Disorder
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to study the connection between REM sleep behavior disorder (RBD) and early signs of neurodegeneration in people taking certain antidepressants. Researchers seek changes in the brain and skin that might indicate early signs of conditions like dementia. The trial will also examine speech changes over time. Ideal participants are those who began acting out their dreams soon after starting an SSRI antidepressant, a medication used to treat depression. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to early detection methods for neurodegenerative diseases.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, it seems that participants are expected to continue their serotonergic medications, as the study involves people who have been on these medications for at least 6 months.
What prior data suggests that these methods are safe for participants?
Previous studies have shown that skin biopsies are a simple and low-risk procedure. They can detect certain proteins related to brain disorders in 75% of patients with related sleep issues, making them reliable and safe for spotting early signs of these conditions.
Research shows that the ultra-high field 7T MRI can clearly display small structures in the brain. This detailed view helps reduce side effects by providing a clear picture of brain activity.
Regarding speech testing, limited data exists on side effects, but it is generally a simple and non-invasive method for checking speech-related problems.
Overall, available research suggests these methods are well-tolerated and safe.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it aims to uncover early signs of neurodegeneration linked to REM Sleep Behavior Disorder (RBD) in people using certain SSRIs (Selective Serotonin Reuptake Inhibitors). Unlike current treatments for RBD that primarily focus on managing symptoms, this study seeks to identify prodromal (early) neurodegenerative changes, potentially offering insights that could lead to earlier and more targeted interventions. By focusing on individuals who do not yet meet the criteria for Parkinson's disease or other neurodegenerative disorders, the trial hopes to better understand the underlying mechanisms and risks associated with serotonergic medication use, paving the way for more personalized treatment strategies in the future.
What evidence suggests that this study's methods are effective for identifying neurodegeneration in REM Sleep Behavior Disorder?
This trial will use skin biopsies, speech testing, and ultra-high-field 7T MRI to study REM Sleep Behavior Disorder (RBD). Research has shown that skin biopsies can detect synuclein deposits in up to 86.7% of people with RBD, which may indicate early signs of brain diseases like Parkinson's. Speech testing also shows promise, as studies have demonstrated its ability to accurately detect speech changes related to RBD. Ultra-high-field 7T MRI provides detailed brain images to identify areas affected by RBD. Together, these tests offer a clearer understanding of how RBD might lead to other conditions.678910
Who Is on the Research Team?
Michael Howell, MD
Principal Investigator
University of Minnesota
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Initial assessment of histopathology, neuroimaging changes, and speech function
Follow-up
Participants are monitored for changes in histopathology, neuroimaging, and speech function
What Are the Treatments Tested in This Trial?
Interventions
- Skin biopsy
- Speech testing
- Ultra high field 7T MRI
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Adults under the age of 75; who do not meet criteria for Parkinson's disease, dementia with Lewy bodies, Alzheimer's disease, other diagnosed neurodegenerative disorder, or other known cause of RBD; and have a history of or currently use the SSRIs of interest.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Minnesota
Lead Sponsor
Citations
New Research Supports Use of Skin Biopsies to Help ...
Research shows 82% of RBD patients have synuclein deposition detected by skin biopsy, aiding early diagnosis of Parkinson's and ...
Biomarkers for REM sleep behavior disorder in idiopathic and ...
A notable finding is the much greater rate of positive synuclein skin biopsy (86.7%) compared to the rate of abnormal DaTscan (36.7%) in the 30 iRBD patients, ...
The role of tissue biopsy as a biomarker in REM sleep ...
This article summarizes the current literature on the role of tissue biopsy in iRBD, with specific focus on its potential role as a biomarker of disease ...
Update on neurodegenerative markers in isolated rapid ...
A meta-analysis showed that more than 95% of patients with iRBD will progress to a certain subtype of α-synucleinopathy within 14 years from diagnosis, with ...
1429 Assessing the Neurodegenerative Progression of REM ...
A diagnosis of RBD or TASD can be distressing for patients due to the risk of progression to a debilitating neurocognitive disorder. This case ...
Syn-One Test Detects Alpha-Synuclein in iRBD Patients
Data from the Syn-Sleep Study shows the Syn-One Test detected phosphorylated alpha-synuclein in skin biopsies of 75% of patients with iRBD ...
A comparative blind study between skin biopsy and seed ...
Our data may favor the use of skin biopsy and aSyn-SAA as diagnostic tools for a synucleinopathy in iRBD.
Skin Biopsy Detection of Phosphorylated α-Synuclein in ...
This cross-sectional study evaluates the rate of detection of cutaneous phosphorylated α-synuclein by skin biopsy in individuals with and ...
1276 The Syn-Sleep Study: Detection of Cutaneous ...
Skin biopsies are a simple, low-risk outpatient procedure to test for P-SYN as a diagnostic biomarker for prodromal synucleinopathies.
10.
molecularneurodegeneration.biomedcentral.com
molecularneurodegeneration.biomedcentral.com/articles/10.1186/s13024-025-00809-0a synopsis of isolated REM sleep behavior disorder as early ...
A comparative blind study between skin biopsy and seed amplification assay to disclose pathological alpha-synuclein in RBD. NPJ Parkinsons ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.