Clinical trial NCT06621602: Quantification of Phosphorylated Alpha-synuclein in Cutaneous Biopsies as a Prospective Biomarker in Parkinson's Disease
Official title: Quantification of Phosphorylated Alpha-synuclein in Cutaneous Biopsies as a Prospective Biomarker in Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: REM Behavior Disorder
Parkinson Disease
Keywords: PD
RBD
Lead sponsor: CND Life Sciences
Sponsor class: OTHER
Collaborators: name: Michael J. Fox Foundation for Parkinson's Research
First posted: 2024-10-01
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subject will be enrolled from approximately 15-20 sites across the US from academic institutions and private clinics.

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.

Eligibility criteria: Inclusion Criteria:

1. Male and female 50 to 100 years of age
2. Clinical confirmed diagnosis of Parkinson\&#39;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

Primary outcomes:
measure: Changes in phosphorylated alpha-synuclein and clinical assessments from Baseline at 18 months
timeFrame: 18 months
measure: Changes in phosphorylated alpha-synuclein and clinical assessments from Baseline at 18 months
timeFrame: 18 months
measure: Changes in phosphorylated alpha-synuclein and clinical assessments from Baseline at 18 months
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: CND Life Sciences
state: Arizona
Study officials:
affiliation: CND Life Sciences
name: Todd Levine
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.