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New treatment option for Dementia With Lewy Bodies
Official title Identification of Prodromal Neurodegeneration in Serotonergic-Induced REM Sleep Behavior Disorder
ClinicalTrials.gov ID: NCT06467461
What this study is testing
- What it's testing
- 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).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75. Healthy volunteers may be eligible.
You may be able to join if
- 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...
You likely can't join if
- 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...
- 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
See the full eligibility criteria
- 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
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Minneapolis, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Minneapolis, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.