Clinical trial NCT05826457: North American Prodromal Synucleinopathy Consortium Stage 2
Official title: North American Prodromal Synucleinopathy Consortium Stage 2
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: REM Sleep Behavior Disorder
Parkinson Disease
Lewy Body Dementia
Dementia With Lewy Bodies
Multiple System Atrophy
REM Sleep Parasomnias
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Mayo Clinic
name: University of Minnesota
name: University of California, Los Angeles
name: McGill University
name: Emory University
name: Massachusetts General Hospital
name: National Institute of Neurological Disorders and Stroke (NINDS)
name: Stanford University
name: National Institutes of Health (NIH)
name: Oregon Health and Science University
name: National Institute on Aging (NIA)
First posted: 2023-04-24
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Idiopathic REM sleep behavior disorder, adults.

Brief summary: 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.

Detailed description: REM sleep behavior disorder (RBD) is a disorder where people act out their dreams. People with RBD often, but not always, develop Parkinson's Disease, dementia with Lewy bodies, multiple system atrophy, or other neurodegenerative diseases of the synucleinopathy type.

The North American Prodromal Synucleinopathy Consortium Stage 2 (NAPS2) was formed with the purpose of enrolling participants with RBD, in anticipation of a future clinical trial of a neuroprotective trreatment against synucleinopathies. The NAPS Consortium will collect standardized clinical assessments, biofluids, and neuroimaging data. The RBD group will also undergo two overnight sleep studies. Some of this data will be used to develop biomarkers for synucleinopathies in the prodromal (presymptomatic) stage as well as a trial-ready registry of participants.

RBD group procedures include a clinical assessment, questionnaires, blood draw, neuroimaging (MRI and DaTscan), polysomnogram (sleep study), and optional lumbar puncture.

Control group procedures include a clinical assessment, questionnaires, blood draw, neuroimaging (MRI), and lumbar puncture.

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

Primary outcomes:
measure: Prodromal Synucleinopathy Rating Scale
timeFrame: up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California Los Angeles
state: California
city: Redwood City
country: United States
facility: Stanford University
state: California
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Portland
country: United States
facility: Oregon Health Sciences University
state: Oregon
city: Montréal
country: Canada
facility: McGill University Health Centre Research Institute
state: Quebec
Study officials:
affiliation: Washington University School of Medicine
name: Yo-El Ju, MD, MCSI
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Brad Boeve, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: McGill University
name: Ron Postuma, MD
role: PRINCIPAL_INVESTIGATOR
References: