REM Sleep Behavior Disorder (iRBD)NCT05757206
The Syn-Sleep Study
An observational study of REM Sleep Behavior Disorder (iRBD), run by CND Life Sciences at 8 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- REM Sleep Behavior Disorder (iRBD)
- What is being tested?
- Syn-One Test
- How many people
- 80 participants
- Where
- 8 sitesUnited States
- Study dates
- 15 Sep 2022to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 80 subjects diagnosed with iRBD
Who may be able to join
- Males and females age 18-85
- Subjects will have repeated episodes of sleep related vocalizations and/or complex motor behaviors
- Sleep-related behaviors/disturbances must be documented by polysomnography to occur during REM sleep
- Polysomnographic recording is consistent with REM sleep without atonia
Who cannot join
- Subjects with MoCA < 19, Hoehn and Yahr score >/=1, contraindications to skin biopsy
- Diagnosis of Parkinson's disease
- Diagnosis of dementia of any type
- Diagnosis of multiple system atrophy
- REM sleep behaviors/disturbances secondary to another cause (e.g., narcolepsy, dementia, and Parkinson's disease)
- Contra-indications to skin biopsy:
Show all 10Show fewer
- Clinical evidence of severe vascular disease (history of ulceration, poor wound healing, and vascular claudication)
- History of allergic reaction to local anesthesia for skin biopsies
- Use of blood thinners (aspirin of Plavix alone is allowed)
- Significantly impaired wound healing or history of scarring or keloid formation
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
MD First Research
Chandler, Arizona, 85286
University of Kentucky
Lexington, Kentucky, 40536
Cedars Sinai Medical Center
Los Angeles, California, 90048
Mount Sinai
New York, New York, 10003
Stanford Neuroscience Health Center
Palo Alto, California, 94304
Banner Health
Phoenix, Arizona, 85006
CND Life Sciences
Scottsdale, Arizona, 85258
Texas Institute for Neurological Disorders
Sherman, Texas, 75092
About this study
Official title: Cutaneous Phosphorylated Alpha-Synuclein for Detection of Prodromal Synucleinopathies
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.
- Conditions
- REM Sleep Behavior Disorder (iRBD)
- Being tested
- Syn-One Test
- Medical subject headings
- REM Sleep Behavior Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Syn-One TestDiagnostic test
Participating subjects will have three small skin punch biopsies.
What is being measured
The primary outcome is the main question the study is designed to answer.
Advance the diagnostic utility of the Syn-One Test
Advance the diagnostic utility of the Syn-One Test™ by defining the metrics of P-SYN deposition and nerve fiber degeneration that predict phenoconversion in iRBD patients.
Measured: 3 years
Enhance pathological reading through digital quantitative analysis of the Syn-One Test
Enhance pathological reading through digital quantitative analysis of the Syn-One Test™ using an AI-augmented detection system. Whole slide imaging with extraction of representative neural structures, target stain detection, segmentation, stain quantification and pattern recognition will be performed using deep learning algorithms. Results will be compared against pathologist readings and actual follow-up data to further refine model accuracy.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2023
- Study start15 Sep 2022
- Primary completion17 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for REM Sleep Behavior Disorder (iRBD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- CND Life Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Todd Levine, Principal investigator, CND Life Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05757206
- Sponsor's protocol ID
- 102
- Status last verified
- Jan 2025
- First submitted
- 17 Feb 2023
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cutaneous Phosphorylated Alpha-Synuclein for Detection of Prodromal Synucleinopathies
- ClinicalTrials.gov ID
- NCT05757206
- Acronym / sponsor ID
- 102
- Conditions
- REM Sleep Behavior Disorder (iRBD)
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (actual)
- Lead sponsor
- CND Life SciencesUniversity, hospital or other
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 17 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 7 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 80 subjects diagnosed with iRBD
Key inclusion criteria (4 listed)
- Males and females age 18-85
- Subjects will have repeated episodes of sleep related vocalizations and/or complex motor behaviors
- Sleep-related behaviors/disturbances must be documented by polysomnography to occur during REM sleep
- Polysomnographic recording is consistent with REM sleep without atonia
Key exclusion criteria (10 listed)
- Subjects with MoCA < 19, Hoehn and Yahr score >/=1, contraindications to skin biopsy
- Diagnosis of Parkinson's disease
- Diagnosis of dementia of any type
- Diagnosis of multiple system atrophy
- REM sleep behaviors/disturbances secondary to another cause (e.g., narcolepsy, dementia, and Parkinson's disease)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Syn-One TestParticipating subjects will have three small skin punch biopsies. | Diagnostic test | – |
Primary outcome
Advance the diagnostic utility of the Syn-One Test
Time frame: 3 years
Advance the diagnostic utility of the Syn-One Test™ by defining the metrics of P-SYN deposition and nerve fiber degeneration that predict phenoconversion in iRBD patients.
Enhance pathological reading through digital quantitative analysis of the Syn-One Test
Time frame: 3 years
Enhance pathological reading through digital quantitative analysis of the Syn-One Test™ using an AI-augmented detection system. Whole slide imaging with extraction of representative neural structures, target stain detection, segmentation, stain quantification and pattern recognition will be performed using deep learning algorithms. Results will be compared against pathologist readings and actual follow-up data to further refine model accuracy.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Todd Levine principal investigator
CND Life Sciences
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of REM Sleep Behavior Disorder (iRBD), run by CND Life Sciences at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Advance the diagnostic utility of the Syn-One Test (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2025.