Systemic Synuclein Sampling Study (S4)

Overview

  • Study type

    Observational
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Scottsdale/Phoenix, Arizona: 15-006596
    NCT ID: NCT02572713
    Sponsor Protocol Number: S4-001

About this study

The purpose of this study is to measure alpha-synuclein in peripheral body tissues and fluids in Parkinson's disease (PD). This may help in developing better treatments for PD patients in the future.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria (PD subjects):

  • Male or female age 40 or older at the time of PD diagnosis.
  • Clinical diagnosis of PD based on bradykinesia plus one of the following: rest tremor or rigidity.
  • DAT deficit at screening based on visual interpretation of DaTSCAN™ imaging.
  • PD subjects will need to fall into one of the following stages:
    • Early untreated PD not requiring dopamine replacement medication (anticholinergics, MAO-B inhibitors and amantadine permitted), Hoehn and Yahr 1-2, < 2 years from diagnosis.
    • Moderate PD responsive and currently treated with dopamine replacement therapy without evidence of motor fluctuations or dyskinesias.
    • Advanced PD with motor fluctuations or dyskinesias, > 5 years from diagnosis.
  • Ability to provide written informed consent in accordance with Good Clinical Practice (GCP), International Conference on Harmonization (ICH), and local regulations.
  • Willing and able to comply with scheduled visits, required study procedures and laboratory tests.

Inclusion Criteria (HC subjects):

  • Male or female age 50 or older at the time of the screening visit
  • Ability to provide written informed consent in accordance with Good Clinical Practice (GCP), International Conference on Harmonization (ICH), and local regulations.
  • Willing and able to comply with scheduled visits, required study procedures and laboratory tests.

Exclusion Criteria (all subjects):

  • Has a history of cancer (other than basal and squamous cell skin cancers), autoimmune disorder, liver disease, or other hematological disorder within the past 5 years.
  • Current treatment with anticoagulants (e.g., Coumadin, heparin) that would preclude safe completion of the lumbar puncture (LP) and tissue biopsy procedures.
  • Current treatment with an antiplatelet agent (Plavix or aspirin >325 mg/day).
  • Has a diagnosis of diabetes mellitus requiring either an oral agent or insulin therapy.
  • A bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia.
  • Has received botulinum toxin injections to the submandibular gland within the past year.
  • Has a condition that precludes safe performance of routine LP, such as prohibitive lumbar spinal disease.
  • Has a condition that precludes the safe performance of the flexible sigmoidoscopy procedure or may interfere with obtaining evaluable colonic tissue biopsies, including a prior colonoscopy with significant findings (e.g. polyp with a positive finding, ulcerative colitis, Crohn's disease, inflammatory disease).
  • Has a condition that precludes the safe performance of the submandibular gland procedure or may interfere with obtaining evaluable submandibular tissue biopsies, including any previous or active significant disease affecting the submandibular gland (e.g. inflammatory disease, infection, tumor).
  • Has a condition that precludes the safe performance of the skin punch biopsy procedure or may interfere with obtaining evaluable skin tissue biopsies, including any previous or active significant dermatological disease (e.g. previous biopsy with any of the following findings: inflammatory disease, scar tissue, psoriasis, keloid formation, skin cancer).
  • Any other medical or psychiatric condition or laboratory abnormality, which in the opinion of the Site Investigator would preclude participation.
  • Use of investigational drugs or devices within 30 days prior to the screening visit.

Exclusion Criteria (PD subjects):

  • Has other significant neurological disorders (clinically significant stroke, brain tumor, hydrocephalus, epilepsy, other neurodegenerative disorders, encephalitis, repeated head trauma, polyneuropathy).
  • Has significant autonomic dysfunction (symptomatic orthostasis, hypotension or urinary incontinence) suggestive of an atypical parkinsonism.
  • Has atypical features of parkinsonism including but not limited to supranuclear gaze palsy, early recurrent falls, corticospinal track abnormalities, cerebellar abnormalities, significant cognitive dysfunction.

Exclusion Criteria (HC subjects):

  • Has a family history of PD in any first-degree relative.
  • Has a significant neurological disorder (a neurodegenerative condition, clinically significant stroke, brain tumor, hydrocephalus, epilepsy, other neurodegenerative disorders, encephalitis, repeated head trauma, polyneuropathy).
  • Has a Montreal Cognitive Assessment (MoCA) score of less than 26.
  • Has a diagnosis of REM sleep behavior disorder.
  • Has a primary dystonia, restless legs syndrome, essential tremor, or other movement disorder.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Charles Adler, M.D., Ph.D.

Contact us for the latest status

Contact information:

Amy Duffy CCRP

(480)301-4750

Duffy.Amy@mayo.edu

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CLS-20318076

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