Clinical trial NCT05757206: The Syn-Sleep Study
Official title: Cutaneous Phosphorylated Alpha-Synuclein for Detection of Prodromal Synucleinopathies
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: REM Sleep Behavior Disorder (iRBD)
Lead sponsor: CND Life Sciences
Sponsor class: OTHER
First posted: 2023-03-07
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 80 subjects diagnosed with iRBD

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.


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

Primary outcomes:
measure: Advance the diagnostic utility of the Syn-One Test
timeFrame: 3 years
measure: Enhance pathological reading through digital quantitative analysis of the Syn-One Test
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Chandler
country: United States
facility: MD First Research
state: Arizona
city: Phoenix
country: United States
facility: Banner Health
state: Arizona
city: Scottsdale
country: United States
facility: CND Life Sciences
state: Arizona
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
city: Palo Alto
country: United States
facility: Stanford Neuroscience Health Center
state: California
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: New York
country: United States
facility: Mount Sinai
state: New York
city: Sherman
country: United States
facility: Texas Institute for Neurological Disorders
state: Texas
Study officials:
affiliation: CND Life Sciences
name: Todd Levine
role: PRINCIPAL_INVESTIGATOR
References: