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A Longitudinal Observational Follow-up of the PRECEPT Study Cohort (PostCEPT)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2008 by The Parkinson Study Group.
Recruitment status was:  Enrolling by invitation
National Institute of Neurological Disorders and Stroke (NINDS)
H. Lundbeck A/S
Parkinson's Disease Foundation
United States Department of Defense
Information provided by:
The Parkinson Study Group Identifier:
First received: January 17, 2008
Last updated: March 26, 2008
Last verified: March 2008
The purpose of this study is to longitudinally follow consenting clinical trial participants who participated in PRECEPT (A Randomized, Double Blind, Placebo Controlled, Dose Finding Study to Assess the Efficacy and Safety of CEP 1347 in Patients With Early Parkinson's Disease). The study will assess the clinical and imaging outcomes relevant to the natural history of Parkinson's disease (PD), as well as determine early biomarkers of the disease.

Parkinson Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: A Longitudinal Observational Follow-up of the PRECEPT Study Cohort

Resource links provided by NLM:

Further study details as provided by The Parkinson Study Group:

Primary Outcome Measures:
  • Unified Parkinson Disease Rating Scale (UPDRS) and β-CIT SPECT imaging of the dopamine transporter. [ Time Frame: Annual, ongoing assessments ]

Secondary Outcome Measures:
  • University of Pennsylvania Smell Identification Test (UPSIT) [ Time Frame: Annual, ongoing assessments ]

Biospecimen Retention:   Samples With DNA
Whole blood

Estimated Enrollment: 530
Study Start Date: August 2006
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Parkinson disease patients who participated in the PRECEPT clinical trial.

Inclusion Criteria:

  • Participation in the PRECEPT study
  • Willing and able to give informed consent

Exclusion Criteria:

  • Patients will be excluded from participating in the the study if either of the criteria stated above is not met
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00605163

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United States, Arizona
Barrow Neurological Institute
Phoenix, Arizona, United States
Sun Health Research Institute
Sun City, Arizona, United States
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
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The Parkinson's & Movement Disorder Institute
Fountain Valley, California, United States
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Irvine, California, United States
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La Jolla, California, United States
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Los Angeles, California, United States
Pacific Neuroscience Medical Group
Oxnard, California, United States
University of California Davis
Sacramento, California, United States
The Parkinson's Institute
Sunnyvale, California, United States
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Aurora, Colorado, United States
Colorado Neurological Institute
Littleton, Colorado, United States
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Institute for Neurogenerative Disorders
New Haven, Connecticut, United States
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Jacksonville, Florida, United States
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Chicago, Illinois, United States
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Kansas City, Kansas, United States
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Shreveport, Louisiana, United States
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Baltimore, Maryland, United States
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Baltimore, Maryland, United States
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Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Boston University
Boston, Massachusetts, United States
Brigham & Women's Hospital
Boston, Massachusetts, United States
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Boston, Massachusetts, United States
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University of Minnesota
Minneapolis, Minnesota, United States
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Creighton University
Omaha, Nebraska, United States
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UMDNJ Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
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Albany, New York, United States
North Shore-LIJ Health System
Manhasset, New York, United States
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New York, New York, United States
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New York, New York, United States
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Rochester, New York, United States
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Duke University Medical Center
Durham, North Carolina, United States
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University of Cincinnati/Cincinnati Children's Hospital
Cincinnati, Ohio, United States
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Portland, Ohio, United States
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Toledo, Ohio, United States
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Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
United States, Rhode Island
NeuroHealth Parkinson's Disease Movement Disorders Center
Warwick, Rhode Island, United States
United States, Tennessee
University of Tennessee-Memphis
Memphis, Tennessee, United States
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Baylor College of Medicine
Houston, Texas, United States
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Charlottesville, Virginia, United States
Canada, Alberta
University of Calgary
Calgary, Alberta, Canada
University of Alberta
Edmonton, Alberta, Canada
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London Health Sciences Centre
London, Ontario, Canada
Ottawa Hospital Civic Site
Ottawa, Ontario, Canada
Toronto Western Hospital, University Health Network
Toronto, Ontario, Canada
Canada, Quebec
University of Sherbrooke
Fleurimont, Quebec, Canada
Hotel-Dieu Hospital-CHUM
Montreal, Quebec, Canada
Canada, Saskatchewan
Saskatoon Disrict Health Board Royal University Hospital
Saskatoon, Saskatchewan, Canada
Sponsors and Collaborators
The Parkinson Study Group
National Institute of Neurological Disorders and Stroke (NINDS)
H. Lundbeck A/S
Parkinson's Disease Foundation
United States Department of Defense
  More Information

Additional Information:
Responsible Party: Ira Shoulson, MD, Principal Investigator, University of Rochester Clinical Trials Coordination Center Identifier: NCT00605163     History of Changes
Other Study ID Numbers: U01NS050095_PostCEPT
NINDS 5 U01NS050095-02
U01NS050095 ( US NIH Grant/Contract Award Number )
Study First Received: January 17, 2008
Last Updated: March 26, 2008

Keywords provided by The Parkinson Study Group:
Parkinson disease, observational, longitudinal

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases processed this record on April 26, 2017