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Enrolling by invitation NCT05826457

North American Prodromal Synucleinopathy Consortium Stage 2

— Observational REM Sleep Behavior Disorder Parkinson Disease Lewy Body Dementia Dementia With Lewy Bodies

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: REM Sleep Behavior Disorder, Parkinson Disease, Lewy Body Dementia, Dementia With Lewy Bodies. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Primary outcome measures

  • Prodromal Synucleinopathy Rating Scale [Time frame: up to 5 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

United States · 8 centers
  • University of California Los Angeles — Los Angeles
  • Stanford University — Redwood City
  • Emory University — Atlanta
  • Massachusetts General Hospital — Boston
  • University of Minnesota — Minneapolis
  • Mayo Clinic Rochester — Rochester
  • Washington University School of Medicine — St Louis
  • Oregon Health Sciences University — Portland
Canada · 1 center
  • McGill University Health Centre Research Institute — Montreal

Publications

  • Boeve BF, Nie Y, Lu R, De La Cruz H, Avidan AY, Bliwise DL, Campbell MC, Criswell SR, Davis AA, Duff K, Elliott J, Ferman TJ, Fields JA, Forsberg LK, Gagnon JF, Howell M, Huddleston DE, Lim MM, Locke J, McCarter SJ, McLeland J, Miglis MG, Miyagawa T, Neilson LE, Nichols K, Pelletier A, Schenck CH, Louis EKS, Sum-Ping O, Trotti LM, Videnovic A, Xiong C, Postuma R, Ju YS; NAPS Consortium. The Prodro PMID 42302227
  • Lim MM, Neilson LE, Elliott JE, Hoang-Dang B, Locke JR, Cunningham H, Brewer J, Dennis L, Dovek L, Pelletier A, St Louis EK, McCarter SJ, Miyagawa T, Davis AA, McLeland JS, Criswell S, Howell MJ, Schenck CH, Avidan AY, Trotti LM, Bliwise DL, Huddleston DE, Videnovic A, Miglis MG, Sum-Ping O, Lee-Iannotti JK, Shprecher DR, Duff K, Ferman TJ, Campbell MC, Fields JA, Gagnon JF, Kotzbauer P, Singer W, PMID 41725984

Identifiers

NCT: NCT05826457 · 202110108 · U19AG071754

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗