Systemic Synuclein Sampling Study (S4)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-10-31

Study Completion Date

2017-08-01

Brief Summary

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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.

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Detailed Description

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This is a multi-center, cross-sectional, observational study to evaluate α-syn pathology in multiple tissues and biofluids in individual subjects with PD and HC at a single time point.

Conditions

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Parkinson's Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Early PD

20 early PD not requiring dopamine replacement therapy have been enrolled.

Biofluid samplings

Intervention Type PROCEDURE

Biofluid samplings (blood, saliva, and cerebrospinal fluid (CSF)

Tissue samplings

Intervention Type PROCEDURE

Tissue samplings (skin, colon, submandibular gland)

DaTSCAN™

Intervention Type DRUG

Moderate PD

20 moderate PD on dopamine replacement therapy without motor fluctuations have been enrolled.

Biofluid samplings

Intervention Type PROCEDURE

Biofluid samplings (blood, saliva, and cerebrospinal fluid (CSF)

Tissue samplings

Intervention Type PROCEDURE

Tissue samplings (skin, colon, submandibular gland)

DaTSCAN™

Intervention Type DRUG

Advanced PD

21 advanced PD with motor fluctuations have been enrolled.

Biofluid samplings

Intervention Type PROCEDURE

Biofluid samplings (blood, saliva, and cerebrospinal fluid (CSF)

Tissue samplings

Intervention Type PROCEDURE

Tissue samplings (skin, colon, submandibular gland)

DaTSCAN™

Intervention Type DRUG

Healthy Controls

21 healthy controls have been enrolled.

Biofluid samplings

Intervention Type PROCEDURE

Biofluid samplings (blood, saliva, and cerebrospinal fluid (CSF)

Tissue samplings

Intervention Type PROCEDURE

Tissue samplings (skin, colon, submandibular gland)

DaTSCAN™

Intervention Type DRUG

Interventions

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Biofluid samplings

Biofluid samplings (blood, saliva, and cerebrospinal fluid (CSF)

Intervention Type PROCEDURE

Tissue samplings

Tissue samplings (skin, colon, submandibular gland)

Intervention Type PROCEDURE

DaTSCAN™

Intervention Type DRUG

Other Intervention Names

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ioflupane-123I

Eligibility Criteria

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Inclusion Criteria

* 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.

* 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

* 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.

* 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.

* 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.

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes