NCT06467461 · RECRUITING
Identification of Prodromal Neurodegeneration in Serotonergic-Induced REM Sleep Behavior Disorder
This study is investigating whether a specific type of REM sleep behavior disorder — triggered by SSRI antidepressants rather than arising on its own — might be an early warning sign of Lewy body dementia or Parkinson's disease. Researchers will use skin biopsies, specialized 7T MRI brain scans, and speech tests to look for early signs of neurodegeneration. This is a Phase NA observational study — it is not testing a treatment, just trying to understand who is at risk and why.
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
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2025-07-08