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Official Study Title: Parkinson Associated Risk Study (PARS): Evaluating Potential Screening  ScreeningPeriod of selection of clinical trial participants based on ELIGIBILITY CRITERIA. Tools for Parkinson's Disease
Sponsor: Department of Defense
Clinicaltrials.gov ID: NCT00387075
Study 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  Parkinson's DiseaseA chronic, slowly progressive disease of the nervous system characterized by the combination of tremor, rigidity, bradykinesia and stooped posture, among other symptoms. (PD) as a tool to establish an 'at risk' PD cohort without motor symptoms  Motor SymptomsThe physical symptoms of PD, such as balance, rigidity, tremor, freeze attacks, involuntary movements (dyskinesia), slowness of movement (bradykinesia), walking/gait, postural difficulties*, writing difficulty, swallowing difficulty* (dysphagia), muscle pain*, masked face*, speech problems* and general loss of motor skills. 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  NeurologistA physician skilled in the diagnosis and treatment of diseases of the nervous system. 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.

Study Phase

Not Specified
What is a study phase?

Symptoms Addressed: Study does not address symptoms

Study does not address symptoms

Time Commitment

• More than six months
• 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

• Gender(s) Accepted: Either
• Study is enrolling non-PD participants

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

Enrollment

Expected Enrollment: 300 (US)
Date Enrollment Began: Jan 2007
Date Enrollment Ends: Jan 2010
Last Updated Date: Sep 23 2008
Trial Post Date: Apr 10 2007
Website: http://www.parsinfosource.com/

Primary Contacts and Locations

Connecticut

• Susan Mendick — Director, Clinical  ClinicalDealing with or based on observation and treatment of people, as opposed to basic science carried out in the laboratory or in animals. Imaging Programs Management
  The Institute for Neurodegenerative Disorders
  smendick@indd.org
  Phone: 203-401-4300
  60 Temple Street, Suite 8B
  New Haven, CT 06510
  USA
  

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