Quantification of Phosphorylated Alpha-synuclein in Cutaneous Biopsies as a Prospective Biomarker in Parkinson's Disease

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

REM Behavior Disorder Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Mental Disorders Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parasomnias Parkinson Disease Parkinsonian Disorders REM Sleep Behavior Disorder REM Sleep Parasomnias Sleep Wake Disorders Synucleinopathies

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CND Life Sciences, Scottsdale, Arizona, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Male and female 50 to 85 years of age
Clinical confirmed diagnosis of Parkinson's disease or REM Sleep Behavior

Exclusion criteria

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

Treatment and study plan

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

CND Life Sciences

Other

Collaborators

Michael J. Fox Foundation for Parkinson's Research

Registry information

Acronym: Syn-Q

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2027
First posted: Oct 1, 2024
Registry last updated: Feb 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Enrolling by Invitation