The Syn-Sleep Study

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

Tracking Information

• First Submitted Date: February 17, 2023
• First Posted Date: March 7, 2023
• Last Update Posted Date: April 11, 2024
• Actual Study Start Date: September 15, 2022
• Estimated Primary Completion Date: August 31, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 3, 2023)

• 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.
• 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.

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Syn-Sleep Study
• Official Title: Cutaneous Phosphorylated Alpha-Synuclein for Detection of Prodromal Synucleinopathies

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.

• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Cross-Sectional
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: 80 subjects diagnosed with iRBD
• Condition: REM Sleep Behavior Disorder (iRBD)

Intervention

Diagnostic Test: Syn-One Test

Participating subjects will have three small skin punch biopsies.

• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: March 3, 2023): 80
• Original Actual Enrollment: Same as current
• Estimated Study Completion Date: August 31, 2025
• Estimated Primary Completion Date: August 31, 2025 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Gender at birth

• Ages: 18 Years to 85 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Jade Stohl; 480-795-3437; jstohl@cndlifesciences.com

Contact: Aracely Galarza; 480-847-0312; agalarza@cndlifesciences.com

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05757206
• Other Study ID Numbers: 102
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: CND Life Sciences
• Original Responsible Party: Same as current
• Current Study Sponsor: CND Life Sciences
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Todd Levine; CND Life Sciences

• PRS Account: CND Life Sciences
• Verification Date: April 2024