Identification of Prodromal Neurodegeneration in Serotonergic-Induced REM Sleep Behavior Disorder

Launched by UNIVERSITY OF MINNESOTA · Jun 14, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a condition called serotonergic REM sleep behavior disorder (5-HT RBD) and its potential links to neurodegenerative diseases like dementia with Lewy bodies and Parkinson's disease. Researchers want to find out if people with 5-HT RBD show signs of brain changes, specific protein buildup in their skin, and speech difficulties. They will compare 30 individuals with 5-HT RBD to 30 people taking similar medications but without sleep issues. The study will last 30 months, during which participants will undergo tests to check their brain health and speech abilities.

To be eligible for the trial, participants with 5-HT RBD must be between 65 and 75 years old and have a confirmed diagnosis of the disorder, which involves acting out dreams after starting a certain type of antidepressant. Control participants should be of similar age and gender, have been on these medications for at least six months, and not have any history of dream enactment. Throughout the study, participants can expect to have skin biopsies, brain scans, and speech assessments to help researchers understand the relationship between sleep behavior and potential brain changes.

Gender

ALL

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