North American Prodromal Synucleinopathy Consortium Stage 2

Parkinson Disease Clinical Trial

— NAPS2  

Official title:

North American Prodromal Synucleinopathy Consortium Stage 2

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05826457
• Other study ID #: 1234567
• Secondary ID: U19AG071754
• Status: Recruiting
• Start date: August 12, 2022
• Est. completion date: May 1, 2025

Study information

• Verified date: April 2024
• Source: Washington University School of Medicine
• Contact: Jennifer McLeland, PhD
• Phone: 314-747-3819
• Email: mclelandj[@]wustl.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: May 1, 2025
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dementia
• Dementia With Lewy Bodies
• Lewy Body Dementia
• Lewy Body Disease
• Mental Disorders
• Multiple System Atrophy
• Parasomnias
• Parkinson Disease
• REM Sleep Behavior Disorder
• REM Sleep Parasomnias
• Shy-Drager Syndrome

Locations

Country	Name	City	State
Canada	McGill University Health Centre Research Institute	Montréal	Quebec
United States	Emory University	Atlanta	Georgia
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	University of California Los Angeles	Los Angeles	California
United States	University of Minnesota	Minneapolis	Minnesota
United States	Oregon Health Sciences University	Portland	Oregon
United States	Stanford University	Redwood City	California
United States	Mayo Clinic Rochester	Rochester	Minnesota
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (12)

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

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prodromal Synucleinopathy Rating Scale	Rating scale combining neurocognitive battery, motor, autonomic, olfaction, color vision functions. Global score range 0-3, with higher score indicating greater symptoms of synucleinopathy.	up to 5 years