Systemic Synuclein Sampling Study (S4)



Status:Recruiting
Conditions:Parkinsons Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:40 - Any
Updated:4/21/2016
Start Date:October 2015
End Date:October 2017
Contact:Holly Riss
Email:holly-riss@uiowa.edu
Phone:319-353-4267

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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.

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.

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.
We found this trial at
7
sites
13400 E. Shea Blvd.
Scottsdale, Arizona 85259
480-301-8000
Principal Investigator: Charles Adler, MD
Phone: 480-301-5523
Mayo Clinic Arizona Mayo Clinic in Arizona provides medical care for thousands of people from...
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Scottsdale, AZ
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Amy Amara, MD
Phone: 205-934-0683
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Birmingham, AL
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Principal Investigator: Penelope Hogarth, MD
Phone: 503-494-1382
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Portland, OR
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Principal Investigator: Kathleen Shannon, MD
Phone: 312-563-2900
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Chicago, IL
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New Haven, Connecticut 06510
Principal Investigator: David Russell, MD
Phone: 203-401-4386
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New Haven, CT
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: Lama Chahine, MD
Phone: 215-829-7374
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Philadelphia, PA
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Toronto, Ontario
Principal Investigator: Connie Marras, MD
Phone: 416-603-5800
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Toronto,
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