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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06621602

Acronym

Syn-Q

Enrollment

100

Registered

2024-10-01

Start date

2024-12-17

Completion date

2027-04-01

Last updated

2026-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease, REM Behavior Disorder

Keywords

PD, RBD

Brief 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. 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

50 Years to 85 Years

Healthy volunteers

Inclusion criteria

1. Male and female 50 to 85 years of age 2. Clinical confirmed diagnosis of Parkinson's disease or REM Sleep Behavior

Exclusion criteria

1. Clinical evidence of severe vascular disease (history of ulceration, poor wound healing or vascular claudication) 2. History of allergic reaction to Lidocaine for local anesthesia needed for skin biopsies 3. Use of blood thinners (Plavix or Aspirin used separately is allowed) 4. Significantly impaired wound healing or history of scarring or keloid formation

Design outcomes

Primary

Measure	Time frame	Description
Changes in phosphorylated alpha-synuclein and clinical assessments from Baseline at 18 months	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 .

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORTodd Levine

CND Life Sciences

Outcome results