REM Behavior DisorderSyn-QNCT06621602
Quantification of Phosphorylated Alpha-synuclein in Cutaneous Biopsies as a Prospective Biomarker in Parkinson's Disease
An observational study of REM Behavior Disorder and Parkinson Disease, run by CND Life Sciences at 18 sites in United States.
Trial summary
This study aims to assess the levels of phosphorylated alpha-synuclein (P-SYN) in patients with Parkinson's disease and REM Behavior Disorder using a minimally invasive skin punch biopsy. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- REM Behavior Disorder, Parkinson Disease
- How many people
- 100 participants
- Where
- 18 sitesUnited States
- Study dates
- 17 Dec 2024to Apr 2027
- 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects will be enrolled from 18 sites across the US from academic institutions and private clinics.
Who may be able to join
- Male and female 50 to 85 years of age
- Clinical confirmed diagnosis of Parkinson's disease or REM Sleep Behavior
Who cannot join
- Clinical evidence of severe vascular disease (history of ulceration, poor wound healing or vascular claudication)
- History of allergic reaction to Lidocaine for local anesthesia needed for skin biopsies
- Use of blood thinners (Plavix or Aspirin used separately is allowed)
- Significantly impaired wound healing or history of scarring or keloid formation
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Atlanta NeuroScience Institute ANI
Atlanta, Georgia, 30327
University of Colorado
Aurora, Colorado, 80045
Aventura Neurologic Associates, LLC
Aventura, Florida, 33180
Parkinson's Disease and Movement Disorders Center - Boca Raton
Boca Raton, Florida, 33486
Boston Neuro Research Center
Boston, Massachusetts, 02747
The Medical University of South Carolina
Charleston, South Carolina, 29403
Parkinson's Research Centers of America - Long Island
Commack, New York, 11725
Parkinson's Research Centers of America - Orange County
Irvine, California, 92618
Parkinson's Disease and Movement Disorders Center at KUMC
Kansas City, Kansas, 66160
Cedars Sinai
Los Angeles, California, 90048
Neurology Multidisciplinary Clinic at Norton Healthcare
Louisville, Kentucky, 40241
Veracity Neuroscience LLC
Memphis, Tennessee, 38157
MedStar Montgomery Medical Center
Olney, Maryland, 20832
Parkinson's Research Centers of America - Palo Alto
Palo Alto, California, 94301
University of Rochester
Rochester, New York, 14618
UT Health San Antonio
San Antonio, Texas, 78229
CND Life Sciences
Scottsdale, Arizona, 85258
Movement Disorders Center of Arizona
Scottsdale, Arizona, 85258
About this study
This study aims to assess the levels of phosphorylated alpha-synuclein (P-SYN) in patients with Parkinson's disease and REM Behavior Disorder using a minimally invasive skin punch biopsy. It seeks to understand the natural progression of P-SYN deposition over time to explore the potential of P-SYN quantification as a biomarker for disease progression.
Read the detailed description
This is a prospective, longitudinal study involving 75 Parkinson's disease patients and 25 patients with REM Behavior Disorder. Each participant will undergo a baseline evaluation followed by follow-ups every six months over an 18-month period. The evaluations will include clinical assessments, neurologic exams, and skin biopsies from three locations. Data will be collected on disease progression and the amount of P-SYN in cutaneous nerve fibers.
- Conditions
- REM Behavior Disorder, Parkinson Disease
- Keywords
- PD, RBD
- Medical subject headings
- REM Sleep Behavior Disorder, Parkinson Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in phosphorylated alpha-synuclein and clinical assessments from Baseline at 18 months
The accuracy of the pathological test in detecting α-synuclein aggregation and deposition in skin punch biopsies.
Measurement of the quantity of phosphorylated alpha-synuclein (P-SYN) in each biopsy to determine whether cutaneous biopsies can serve as a biomarker for changes in P-SYN deposition over time .
Measured: 18 months
Changes in phosphorylated alpha-synuclein and clinical assessments from Baseline at 18 months
The precision of the pathological test in detecting α-synuclein aggregation and deposition in skin punch biopsies. Measurement of the quantity of phosphorylated alpha-synuclein (P-SYN) in each biopsy to determine whether cutaneous biopsies can serve as a biomarker for changes in P-SYN deposition over time .
Time Frame: 18 months
Measured: 18 months
Changes in phosphorylated alpha-synuclein and clinical assessments from Baseline at 18 months
The sensitivity of the pathological test in detecting α-synuclein aggregation and deposition in skin punch biopsies. Measurement of the quantity of phosphorylated alpha-synuclein (P-SYN) in each biopsy to determine whether cutaneous biopsies can serve as a biomarker for changes in P-SYN deposition over time . Time Frame: 18 months Time Frame: 18 months
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start17 Dec 2024
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for REM Behavior DisorderStudies 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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CND Life Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research
- Responsible party
- Sponsor
- Investigators
- Todd Levine, Principal investigator, CND Life Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06621602
- Sponsor's protocol ID
- MJFF-025208
- Acronym
- Syn-Q
- Status last verified
- Oct 2026
- First submitted
- 23 Sep 2024
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gibbons CH, Levine T, Adler C, Bellaire B, Wang N, Stohl J, Agarwal P, Aldridge GM, Barboi A, Evidente VGH, Galasko D, Geschwind MD, Gonzalez-Duarte A, Gil R, Gudesblatt M, Isaacson SH, Kaufmann H, Khemani P, Kumar R, Lamotte G, Liu AJ, McFarland NR, Miglis M, Reynolds A, Sahagian GA, Saint-Hillaire MH, Schwartzbard JB, Singer W, Soileau MJ, Vernino S, Yerstein O, Freeman R. Skin Biopsy Detection of Phosphorylated alpha-Synuclein in Patients With Synucleinopathies. JAMA. 2024 Apr 16;331(15):1298-1306. doi: 10.1001/jama.2024.0792.
PubMed 38506839Parent JH, Levine T, Freeman R, Gibbons CH. The Syn-Q study: detection of cutaneous phosphorylated alpha-synuclein in Parkinson's disease progression: a trial protocol. Front Neurol. 2026 Apr 14;17:1823991. doi: 10.3389/fneur.2026.1823991. eCollection 2026.
PubMed 42057930
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantification of Phosphorylated Alpha-synuclein in Cutaneous Biopsies as a Prospective Biomarker in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06621602
- Acronym / sponsor ID
- Syn-Q / MJFF-025208
- Conditions
- REM Behavior Disorder, Parkinson Disease
- Keywords
- PD, RBD
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- CND Life SciencesUniversity, hospital or other
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research
- Study start
- 17 Dec 2024 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 1 Oct 2024 (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.
This study aims to assess the levels of phosphorylated alpha-synuclein (P-SYN) in patients with Parkinson's disease and REM Behavior Disorder using a minimally invasive skin punch biopsy. It seeks to understand the natural progression of P-SYN deposition over time to explore the potential of P-SYN quantification as a biomarker for disease progression.
Detailed description
This is a prospective, longitudinal study involving 75 Parkinson's disease patients and 25 patients with REM Behavior Disorder. Each participant will undergo a baseline evaluation followed by follow-ups every six months over an 18-month period. The evaluations will include clinical assessments, neurologic exams, and skin biopsies from three locations. Data will be collected on disease progression and the amount of P-SYN in cutaneous nerve fibers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be enrolled from 18 sites across the US from academic institutions and private clinics.
Key inclusion criteria (2 listed)
- Male and female 50 to 85 years of age
- Clinical confirmed diagnosis of Parkinson's disease or REM Sleep Behavior
Key exclusion criteria (4 listed)
- Clinical evidence of severe vascular disease (history of ulceration, poor wound healing or vascular claudication)
- History of allergic reaction to Lidocaine for local anesthesia needed for skin biopsies
- Use of blood thinners (Plavix or Aspirin used separately is allowed)
- Significantly impaired wound healing or history of scarring or keloid formation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes in phosphorylated alpha-synuclein and clinical assessments from Baseline at 18 months
Time frame: 18 months
The accuracy of the pathological test in detecting α-synuclein aggregation and deposition in skin punch biopsies. Measurement of the quantity of phosphorylated alpha-synuclein (P-SYN) in each biopsy to determine whether cutaneous biopsies can serve as a biomarker for changes in P-SYN deposition over time .
Changes in phosphorylated alpha-synuclein and clinical assessments from Baseline at 18 months
Time frame: 18 months
The precision of the pathological test in detecting α-synuclein aggregation and deposition in skin punch biopsies. Measurement of the quantity of phosphorylated alpha-synuclein (P-SYN) in each biopsy to determine whether cutaneous biopsies can serve as a biomarker for changes in P-SYN deposition over time . Time Frame: 18 months
Changes in phosphorylated alpha-synuclein and clinical assessments from Baseline at 18 months
Time frame: 18 months
The sensitivity of the pathological test in detecting α-synuclein aggregation and deposition in skin punch biopsies. Measurement of the quantity of phosphorylated alpha-synuclein (P-SYN) in each biopsy to determine whether cutaneous biopsies can serve as a biomarker for changes in P-SYN deposition over time . Time Frame: 18 months Time Frame: 18 months
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 20 Oct 2026.
- Results publication: PubMed 38506839Gibbons CH, Levine T, Adler C, Bellaire B, Wang N, Stohl J, Agarwal P, Aldridge GM, Barboi A, Evidente VGH, Galasko D, Geschwind MD, Gonzalez-Duarte A, Gil R, Gudesblatt M, Isaacson SH, Kaufmann H, Khemani P, Kumar R, Lamotte G, Liu AJ, McFarland NR, Miglis M, Reynolds A, Sahagian GA, Saint-Hillaire MH, Schwartzbard JB, Singer W, Soileau MJ, Vernino S, Yerstein O, Freeman R. Skin Biopsy Detection of Phosphorylated alpha-Synuclein in Patients With Synucleinopathies. JAMA. 2024 Apr 16;331(15):1298-1306. doi: 10.1001/jama.2024.0792.
- Derived from this study: PubMed 42057930Parent JH, Levine T, Freeman R, Gibbons CH. The Syn-Q study: detection of cutaneous phosphorylated alpha-synuclein in Parkinson's disease progression: a trial protocol. Front Neurol. 2026 Apr 14;17:1823991. doi: 10.3389/fneur.2026.1823991. eCollection 2026.
- 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
18 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 Behavior Disorder and Parkinson Disease, run by CND Life Sciences at 18 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 2 inclusion and 4 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 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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?
Changes in phosphorylated alpha-synuclein and clinical assessments from Baseline at 18 months (time frame: 18 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06621602, which also lists 2 linked publications.
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 20 Oct 2026.