NAPS2: North American Prodromal Synucleinopathy Consortium Stage 2

Sponsor

Washington University School of Medicine (Other)

Overall Status

Recruiting

CT.gov ID

NCT05826457

Collaborator

Mayo Clinic (Other), University of Minnesota (Other), University of California, Los Angeles (Other), McGill University (Other), Emory University (Other), Massachusetts General Hospital (Other), National Institutes of Health (NIH) (NIH), National Institute of Neurological Disorders and Stroke (NINDS) (NIH), Stanford University (Other), Oregon Health and Science University (Other), National Institute on Aging (NIA) (NIH)

500

Enrollment

Locations

32.6

Anticipated Duration (Months)

55.6

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
REM Sleep Behavior Disorder Parkinson Disease Lewy Body Dementia Dementia With Lewy Bodies Multiple System Atrophy REM Sleep Parasomnias

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

500 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

North American Prodromal Synucleinopathy Consortium Stage 2

Actual Study Start Date :

Aug 12, 2022

Anticipated Primary Completion Date :

May 1, 2025

Anticipated Study Completion Date :

May 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
RBD Group Clinical observation involving annual visits to a study site for up to 5 years.
Control Group Clinical observation involving annual visits to a study site for up to 5 years.

Outcome Measures

Primary Outcome Measures

Prodromal Synucleinopathy Rating Scale [up to 5 years]
Rating scale combining neurocognitive battery, motor, autonomic, olfaction, color vision functions. Global score range 0-3, with higher score indicating greater symptoms of synucleinopathy.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria for RBD Group

Polysomnogram-confirmed RBD by ICSD-3 criteria
Capable of providing informed consent at time of study enrollment
Age > 18 years

Exclusion Criteria for RBD Group

Diagnosis of PD, dementia of any type, or MSA unless previous participant in NAPS1.
Narcolepsy-associated RBD
RBD secondary to any known cause except prodromal synucleinopathy.
Participation in a clinical trial, except by specific permission by the Executive Committee
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

Ability to provide written consent
Age > 18 years
Must meet age, sex, and race matching criteria per the Data Management and Statistical core recommendations for the site
Must be willing to undergo all testing procedures, including neuroimaging and lumbar puncture.
Normal capacity to perform complex activities of daily living independently based on informant or physician report

Exclusion Criteria for Control Group

History of dream enactment behavior to suggest RBD
Parkinsonism, MSA, dementia, or mild cognitive impairment
Active central nervous system, systemic, psychiatric condition or use of psychoactive medication that would adversely affect cognitive, neuropsychiatric, motor, or autonomic functioning.
Contraindications to complete MRI.
Contraindications to lumbar puncture.
Participation in a clinical trial, except by specific permission by the Executive Committee
In the opinion of the investigator, the individual has a clinically significant uncontrolled medical condition that would impede safe completion of the study protocol

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California Los Angeles	Los Angeles	California	United States	90095
2	Stanford University	Redwood City	California	United States	94063
3	Emory University	Atlanta	Georgia	United States	30322
4	Massachusetts General Hospital	Boston	Massachusetts	United States	02145
5	University of Minnesota	Minneapolis	Minnesota	United States	55414
6	Mayo Clinic Rochester	Rochester	Minnesota	United States	55905
7	Washington University School of Medicine	Saint Louis	Missouri	United States	63110
8	Oregon Health Sciences University	Portland	Oregon	United States	97239
9	McGill University Health Centre Research Institute	Montréal	Quebec	Canada	H4A 3J1