REM Sleep Behavior Disorder for Synucleinopathy Research

(NAPS Trial)

Enrolling by invitation at 11 trial locations
YJ
JM
Overseen ByJennifer McLeland
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Washington University School of Medicine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to prepare for future studies on treatments that protect against synucleinopathies, brain disorders linked to proteins. It focuses on individuals with idiopathic REM sleep behavior disorder (RBD), where people act out their dreams due to abnormal sleep patterns. Those with this condition, without a known cause like Parkinson's or narcolepsy, might be suitable candidates. The goal is to better understand the condition to develop effective treatments later.

As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking advancements in treatment.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

Why are researchers excited about this trial?

The North American Prodromal Synucleinopathy Consortium is unique because it aims to better understand the early stages of synucleinopathies, like Parkinson's disease. Researchers are excited about this trial because it holds the potential to identify early biomarkers and progression patterns, which are not well-defined in current treatment approaches. This could lead to earlier diagnosis and more targeted interventions, potentially slowing the disease's progression before symptoms become severe.

Who Is on the Research Team?

BB

Bradley Boeve, MD

Principal Investigator

Mayo Clinic

YJ

Yo-El Ju, MD

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

Inclusion Criteria

Idiopathic REM sleep behavior disorder

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo a ~2-hour clinical assessment including medical history, physical exam, questionnaires, and blood draw. Optional lumbar puncture at select sites.

1 day
1 visit (in-person)

Data Collection

Standardized clinical assessments and biofluids are collected to develop biomarkers for synucleinopathies.

2 years

Follow-up

Participants are monitored for safety and effectiveness after data collection

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • NA

Find a Clinic Near You

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials
2,027
Recruited
2,353,000+

Portland VA Medical Center

Collaborator

Trials
44
Recruited
7,800+

University of California, Los Angeles

Collaborator

Trials
1,594
Recruited
10,430,000+

Massachusetts General Hospital

Collaborator

Trials
3,066
Recruited
13,430,000+

National Institute on Aging (NIA)

Collaborator

Trials
1,841
Recruited
28,150,000+

Stanford University

Collaborator

Trials
2,527
Recruited
17,430,000+

Banner Health

Collaborator

Trials
26
Recruited
1,006,000+

Emory University

Collaborator

Trials
1,735
Recruited
2,605,000+

McGill University

Collaborator

Trials
421
Recruited
1,017,000+

University of Minnesota

Collaborator

Trials
1,459
Recruited
1,623,000+