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The Syn-Sleep Study

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ClinicalTrials.gov Identifier: NCT05757206
Recruitment Status : Recruiting
First Posted : March 7, 2023
Last Update Posted : April 11, 2024
Sponsor:
Information provided by (Responsible Party):
CND Life Sciences

Study Description
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Brief Summary:

In collaboration with approximately 8 centers that specialize in iRBD we will recruit a total of 80 individuals for the study. All subjects will be enrolled into a 2-year longitudinal study where skin biopsies will be performed at 3 sites on each patient at 12-month intervals (baseline, year 1, year 2). Plasma blood collection will be performed at 12-month intervals (baseline, year 1, year 2). Detailed quantified examination, cognitive evaluation, medical history, and questionnaires will be performed at each visit. Additional biomarker, imaging and clinical information (if available) will be obtained for the purpose of determining phenoconversion to clinically apparent synucleinopathy.

Subjects enrolled in the study will have baseline evaluations and follow up visits at 12 and 24 months to define any changes to clinical diagnosis (clinical phenoconversion). Skin biopsies will be repeated at the 12- and 24-month follow up visits to determine the rate of P-SYN accumulation over time and the rates of nerve fiber degeneration within punch skin biopsies.


Condition or disease Intervention/treatment
REM Sleep Behavior Disorder (iRBD) Diagnostic Test: Syn-One Test

Study Design
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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Cutaneous Phosphorylated Alpha-Synuclein for Detection of Prodromal Synucleinopathies
Actual Study Start Date : September 15, 2022
Estimated Primary Completion Date : August 31, 2025
Estimated Study Completion Date : August 31, 2025
Groups and Cohorts
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Intervention Details:
  • Diagnostic Test: Syn-One Test
    Participating subjects will have three small skin punch biopsies.

Outcome Measures
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Primary Outcome Measures :
  1. Advance the diagnostic utility of the Syn-One Test [ Time Frame: 3 years ]
    Pathologically distinguish DLB from AD early in the course of disease using the Syn-One Test, confirming disease diagnosis through prospective clinical assessments (Neuro exam, NACC data set, and DLB Module) and follow-up analyses over 12 months.

  2. Enhance pathological reading through digital quantitative analysis of the Syn-One Test [ Time Frame: 3 years ]
    Define the rates of neuronal degeneration in DLB through systematic pathological quantitation, measuring P-SYN deposition and cutaneous nerve fiber degeneration, compared to AD, and correlating pathological findings with clinical assessments (Neuro exam, NACC data set, and DLB Module) over the course of 12 months.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Gender at birth
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
80 subjects diagnosed with iRBD
Criteria

Inclusion Criteria:

  1. Males and females age 18-85
  2. Subjects will have repeated episodes of sleep related vocalizations and/or complex motor behaviors
  3. Sleep-related behaviors/disturbances must be documented by polysomnography to occur during REM sleep
  4. Polysomnographic recording is consistent with REM sleep without atonia

Exclusion Criteria:

  1. Subjects with MoCA < 19, Hoehn and Yahr score >/=1, contraindications to skin biopsy
  2. Diagnosis of Parkinson's disease
  3. Diagnosis of dementia of any type
  4. Diagnosis of multiple system atrophy
  5. REM sleep behaviors/disturbances secondary to another cause (e.g., narcolepsy, dementia, and Parkinson's disease)

  6. Contra-indications to skin biopsy:

    1. Clinical evidence of severe vascular disease (history of ulceration, poor wound healing, and vascular claudication)
    2. History of allergic reaction to local anesthesia for skin biopsies
    3. Use of blood thinners (aspirin of Plavix alone is allowed)
    4. Significantly impaired wound healing or history of scarring or keloid formation
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05757206


Contacts
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Contact: Jade Stohl 480-795-3437 jstohl@cndlifesciences.com
Contact: Aracely Galarza 480-847-0312 agalarza@cndlifesciences.com

Locations
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United States, Arizona
MD First Research Not yet recruiting
Chandler, Arizona, United States, 85286
Contact: Alexandra Jensen    520-524-5030    ajensen@brainandspineaz.com   
Contact: Morning Star Lewis    480-510-8993    mslewis@brainandspineaz.com   
Principal Investigator: Hemant Pandey         
Sub-Investigator: Angela Rush         
Banner Health Recruiting
Phoenix, Arizona, United States, 85006
Contact: Judy Galaz    602-521-3300    cgalaz@arizona.edu   
Principal Investigator: Joyce Lee-Iannotti, MD         
CND Life Sciences Recruiting
Scottsdale, Arizona, United States, 85258
Contact: Farah Ismail    480-434-6382    fismail@cndlifesciences.com   
Principal Investigator: Todd Levine, MD         
United States, California
Cedars Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Michele Gregorio    424-315-0021    michele.gregorio@cshs.org   
Contact: MaryClare Kelly    310-423-8497    MaryClare.Kelly@cshs.org   
Principal Investigator: Michele Tagliati, MD         
Stanford Neuroscience Health Center Recruiting
Palo Alto, California, United States, 94304
Contact: Brianna Heath    650-421-6634    bheath@stanford.edu   
Contact: Jordan Seliger    650-460-9260    jseliger@stanford.edu   
Principal Investigator: Mitch Miglis, MD         
United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536
Contact: Matt Taylor    859-218-0311    matt.taylor@uky.edu   
Principal Investigator: Daniel Lee, MD         
United States, New York
Mount Sinai Recruiting
New York, New York, United States, 10003
Contact: Salonee Marwaha    917-946-3862    salonee.marwaha@mssm.edu   
Principal Investigator: Emmanuel During, MD         
United States, Texas
Texas Institute for Neurological Disorders Recruiting
Sherman, Texas, United States, 75092
Contact: Laurie Jarvis       ljarvis@texasneurologyinstitute.com   
Sub-Investigator: Indu Mayakrishnan, MD         
Sponsors and Collaborators
CND Life Sciences
Investigators
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Principal Investigator: Todd Levine CND Life Sciences
More Information
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Responsible Party: CND Life Sciences
ClinicalTrials.gov Identifier: NCT05757206    
Other Study ID Numbers: 102
First Posted: March 7, 2023    Key Record Dates
Last Update Posted: April 11, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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REM Sleep Behavior Disorder
Mental Disorders
REM Sleep Parasomnias
 Parasomnias
Sleep Wake Disorders
Nervous System Diseases