Ensayos clínicos

Inclusion Criteria - RBD Group:

• All participants must have polysomnogram-confirmed RBD by ICSD-3 criteria [AASM 2014]. An EDF of a polysomnogram demonstrating RSWA must be available from NAPS1 or obtainable from elsewhere to verify this entry criterion.
• Capable of providing informed consent at time of NAPS2 study enrollment, unless the participant previously enrolled in NAPS1:
  • For individuals previously enrolled in NAPS1 who developed cognitive decline and are no longer able to provide informed consent prior to enrollment in NAPS2, informed consent will be obtained from the legally authorized representative, and written assent obtained from the participant;
  • Individuals who enroll in NAPS2 will identify a proxy at initial enrollment. If a participant subsequently develops cognitive decline and is no longer able to provide informed consent for revised consent documents during follow-up visits, the proxy or legally authorized representative (depending on local regulations) will be asked to provide informed consent, and written assent obtained from the participant.
• Age ≥ 18 years.

Exclusion Criteria - RBD Group:

• PD, dementia of any type, or MSA unless the individual was previously enrolled in NAPS1. Participants who phenoconvert during NAPS2 will be eligible to continue participation if they enrolled at a time when they were capable for providing informed consent.
  • Coexisting cognitive, motor, or autonomic symptoms are permitted in the RBD group provided that a diagnosis of dementia, PD, MSA, or any other overt neurodegenerative phenotype is not present;
  • The presence of “soft” cognitive, motor, autonomic, or other neurologic symptoms are appropriate for inclusion since 1) such features are common among RBD patients in the clinical setting, 2) such features are common in NAPS1participants,3) the NAPS2 program is designed to mimic recruitment of RBD patients who may be appropriate for participation in clinical trials, and 4) a primary goal of NAPS2 is to identify those at short-term risk of phenoconversion since clinical trials will focus on such RBD patient.
• 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 participant has a clinically significant uncontrolled medical condition that would impede safe completion of the study protocol. 

Exclusions for Specific Procedures - RBD Group:

RBD participants will not be excluded from NAPS2 for the following exclusions; they will be excluded from undergoing the specific procedure(s).

• Exclusions specific for MRI include any of the following:
  • metal implant or pacemaker;
  • Pregnancy;
  • Head/shoulder or body girth/weight unable to fit in the MRI scanner and coils;
  • Note that RBD participants who have claustrophobia or other issues completing MRI will not be excluded necessarily from MRI;
• Exclusions specific for DaTscan SPECT include any of the following:
  • Pregnancy;
  • Head/shoulder or body girth/weight unable to fit in the SPECT scanner;
  • Note that RBD participants who have claustrophobia or other issues completing DaTscan will not be excluded necessarily from DaTscan;
  • Note that RBD participants who take concomitant medications that are potentially interfering for DaTscan as listed in the NI Manual of Procedures will not be excluded necessarily from DaTscan, but the specific medication(s) will be held if possible per site-specific protocols and at the discretion of the local Site Investigator. Any such medications will be noted in source documents at the time of scan.
  • History of an allergic reaction to iodine and iodine-containing products such as IV contrast dye (used for CT scans, IVPs, etc.). An allergy to shellfish is not exclusionary.
• Exclusions specific for lumbar puncture include any of the following:
  • Diagnosis of a bleeding disorder;
  • Anticoagulant medication (coumadin, aspirin, etc.) is at the discretion of the local Site Investigator.  Site-specific procedures for lumbar puncture should be followed.

Inclusion Criteria - Control Group:

• Ability to provide written consent.
• Age ≥ 18 years
• Must meet age, sex, and race matching criteria per the DMS core recommendations for the site.
• Must be willing and able 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 - 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:
• • Since the goal is to include typical normal persons, the Controls may include participants with adequately controlled medical and psychiatric conditions (based on physician determination and stratification in the RBD cohort);
  • This includes the use of stable doses of antidepressant medications, and their presence will be factored into any RBD vs Controls analyses.
• Contraindications to complete MRI, including any of the following:
  •  
  • metal implant or pacemaker;
  • too claustrophobic to complete MRI scans;
  • previous issue completing an MRI;
  • Pregnancy;
  • Head/shoulder or body girth unable to fit in the MRI scanner and coils;
  • Body mass index > 35 kg/m^2 or weight > 300 lbs, due to neuroimaging scanner limits;
  • Participation in a clinical trial, except by specific permission by the Executive Committee;
  • In the opinion of the investigator, the participant has a clinically significant uncontrolled medical condition.
• Contraindications to complete lumbar puncture:
  • Diagnosis of a bleeding disorder;
  • Anticoagulant medication (coumadin, aspirin, etc.) is at the discretion of the local Site Investigator.  Site-specific procedures for lumbar puncture should be followed.

Eligibility last updated 1/14/22. Questions regarding updates should be directed to the study team contact.