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
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