Parkinson Associated Risk Study (PARS): Evaluating Potential Screening Tools for Parkinson's Disease

Official Study Title: Parkinson Associated Risk Study (PARS): Evaluating Potential Screening Tools for Parkinson's Disease

Sponsor: Department of Defense
Clinicaltrials.gov ID: NCT00387075
Study ID: 135
Trial Start Date: 15 Jan 2007
Last Updated Date: 13 Apr 2007
Trial Post date: 10 Apr 2007
Website URL: http://www.pdtrials.org/front/trial_...p?trial_id=135

Summary

This study is designed to test the strategy of combining two biomarkers of parkinsonism, olfaction (sense of smell) and brain imaging in first-degree relatives of people with Parkinson’s disease (PD) as a tool to establish an ‘at risk’ PD cohort without motor symptoms of PD.

The PARS Study is the largest long-term study in the United States of relatives of individuals with PD. It will evaluate a maximum of 7,500 relatives for 3-5 years, and follow a group of 300 individuals over a two year period, to determine whether specific tests are able to predict who may be at increased risk for developing PD. The goal of the PARS study is to better understand who is at risk for PD so that it can ultimately be prevented before it starts.

The initial tool to be evaluated will be a test of the sense of smell. First-degree relatives of someone who has PD who are interested in this study will be asked to complete a form with their contact information. Eligible participants will be sent a scratch-and-sniff smell test and a brief questionnaire to be completed at home. Eligible participants may also be contacted to continue the mail-in questionnaires annually or to be evaluated by a neurologist near their home. Some individuals may be asked to undergo more extensive testing, including brain imaging using a radioactive labeled drug, [123I]b-CIT. The level of participation is optional.

Enrollment
Expected Enrollment: 300

Trial Phase
Study Phase: Not Specified (About Phases)

Symptoms
# Trial does not treat PD symptoms

Time Commitment
Length of Time Commitment: More than six months
Frequency of office visits:

• 20-30 minutes to complete surveys at home.
• One hour clinic visit.
• Three days if traveling to New Haven to be imaged.
• Every 12-18 months.

Eligibility
Trial accepts healthy volunteers

Inclusion Criteria

• Must have a first-degree relative with PD
• Must be EITHER at least 50 yrs old OR within 10 years of the age of onset of their affected relative

Exclusion Criteria

• Diagnosis of PD or other neurodegenerative disorder
• Any other known reason for loss of the sense of smell (e.g. nasal trauma, sinus infection, sinus surgery)
• Pregnancy, if participating in the imaging portion of this study

Primary Contact
Susan Mendick
Director, Clinical Imaging Programs Management
The Institute for Neurodegenerative Disorders
Phone : 203-401-4300
smendick@indd.org
60 Temple Street, Suite 8B
New Haven, CT 06510
USA

Local Contacts
Mayo Clinic Arizona
13400 E Shea Blvd.
Scottsdale, AZ 85259
USA

UCLA Medical Center
Reed Neurological Research Center
710 Westwood Plaza A-253
Los Angeles, CA 90095
USA

San Francisco VA PADRECC
4150 Clement Street 127P
San Francisco, CA 94121
USA

The Parkinson's Institute
1170 Morse Avenue
Sunnyvale, CA 94089
USA

USF Parkinson's Disease & Movement Disorders Center
4 Columbia Drive
Suite 410
Tampa, FL 33606
USA

Emory University
Wesley Woods Health Center
1841 Clifton Rd. 3rd Fl
Atlanta, GA 30329
USA

Medical College of Georgia
1429 Harper Street
HF 1121
Augusta, GA
USA

Northwestern University
710 No. Shore Lake Dr.
Abbott Hall, 11th Fl.
Chicago, IL 60611
USA

Boston University Medical Center
Dept of Neurology
715 Albany Street, C329
Boston, MA 02118
USA

UNC Department of Neurology
Movement Disorders Clinic
3114 Bioinformatics CB #7025
Chapel Hill, NC 27599
USA

Beth Israel Medical Center
10 Union Square East
Suite 5H
New York, NY 10003
USA

University of Rochester
919 Westfall Road Bldg C
Suite 220
Rochester, NY 14618
USA

Portland VA Medical Center PADRECC
3710 SW US Veterans Hospital Road
P3-PADRECC
Portland, OR 97239
USA

Parkinson's Disease and Movement Disorders Center
330 S. 9th Street
Philadelphia, PA 19107
USA

Neurohealth
227 Centerville Road
Warwick, RI 02886
USA

Michael E. DeBakey VA Medical Center
2002 Holcombe Blvd. PADRECC
Neurology Care Line 127PD
Houston, TX 77030
USA

Hunter Holmes McGuire VA Medical Center
1201 Broad Rock Blvd.
Richmond, VA 23249
USA

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Full Details:

PDTrials.org http://www.pdtrials.org/front/trial_...p?trial_id=161

• All Trials
• By Trial Type
• By Symptom
• By Location

ClinicalTrials.gov http://clinicaltrials.gov/ct/show/NCT00427674?order=1[LIST][*]Complete list of PD trials

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Parkinson Pipeline Project
www.pdpipeline.org
Following theapies from pre-clinical development to approval in the Parkinson Pipeline Project Database (see homepage for link to database)

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