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North American Prodromal Synucleinopathy Consortium Stage 2

Enrolling By InvitationN/A

Sponsor: Washington University School of Medicine

Conditions: REM Sleep Behavior Disorder, Parkinson Disease, Lewy Body Dementia, Dementia With Lewy Bodies, Multiple System Atrophy

Countries: United States, Canada

This study will enroll participants with idiopathic REM sleep behavior disorder (RBD) and healthy controls for the purpose of preparing for a clinical trial of neuroprotective treatments against synucleinopathies.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: Yes

Study type: OBSERVATIONAL

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

Locations (9)

Los Angeles, California, United States
Redwood City, California, United States
Atlanta, Georgia, United States
Boston, Massachusetts, United States
Minneapolis, Minnesota, United States
Rochester, Minnesota, United States
St Louis, Missouri, United States
Portland, Oregon, United States
Montreal, Quebec, Canada