North American Prodromal Synucleinopathy Consortium Stage 2

Launched by WASHINGTON UNIVERSITY SCHOOL OF MEDICINE · Apr 20, 2023

Keywords

ClinConnect Summary

The North American Prodromal Synucleinopathy Consortium Stage 2 trial is looking to understand more about a condition called REM Sleep Behavior Disorder (RBD) and how it might relate to other diseases like Parkinson's disease and Lewy body dementia. The goal is to prepare for future studies on treatments that could protect the brain from these conditions. The trial will include people with RBD, who will be compared to healthy individuals, to see how their experiences differ and gather valuable information for upcoming research.

To participate, individuals with RBD must be at least 18 years old and have a confirmed diagnosis of RBD through a sleep study. They cannot have other serious conditions like Parkinson's or dementia. Healthy participants are also needed, and they must be over 18, able to provide consent, and willing to undergo tests, including brain scans and spinal taps. Throughout the study, participants can expect regular assessments and tests aimed at understanding the impact of RBD and its connection to other neurological conditions. Your participation could help advance research in this area and improve future treatments.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria for RBD Group
• • 1. Polysomnogram-confirmed RBD by ICSD-3 criteria
• • 2. Capable of providing informed consent at time of study enrollment
• • 3. Age \> 18 years
• • Exclusion Criteria for RBD Group
• • 1. Diagnosis of PD, dementia of any type, or MSA unless previous participant in NAPS1.
• • 2. Narcolepsy-associated RBD
• • 3. RBD secondary to any known cause except prodromal synucleinopathy.
• • 4. Participation in a clinical trial, except by specific permission by the Executive Committee
• • 5. In the opinion of the investigator, the individual has a clinically significant uncontrolled medical condition that would impede safe completion of the study protocol
• • Inclusion Criteria for Control Group
• • 1. Ability to provide written consent
• • 2. Age \> 18 years
• • 3. Must meet age, sex, and race matching criteria per the Data Management and Statistical core recommendations for the site
• • 4. Must be willing to undergo all testing procedures, including neuroimaging and lumbar puncture.
• • 5. Normal capacity to perform complex activities of daily living independently based on informant or physician report
• • Exclusion Criteria for Control Group
• • 1. History of dream enactment behavior to suggest RBD
• • 2. Parkinsonism, MSA, dementia, or mild cognitive impairment
• • 3. Active central nervous system, systemic, psychiatric condition or use of psychoactive medication that would adversely affect cognitive, neuropsychiatric, motor, or autonomic functioning.
• • 4. Contraindications to complete MRI.
• • 5. Contraindications to lumbar puncture.
• • 6. Participation in a clinical trial, except by specific permission by the Executive Committee
• • 7. In the opinion of the investigator, the individual has a clinically significant uncontrolled medical condition that would impede safe completion of the study protocol