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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00605163
Recruitment Status : Unknown
Verified March 2008 by The Parkinson Study Group.
Recruitment status was:  Enrolling by invitation
First Posted : January 30, 2008
Last Update Posted : March 28, 2008
Sponsor:
Collaborators:
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

Study Description
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Brief Summary:
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.

Condition or disease
Parkinson Disease

Study Design
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Study Type : Observational
Estimated Enrollment : 530 participants
Observational Model: Cohort
Official Title: A Longitudinal Observational Follow-up of the PRECEPT Study Cohort
Study Start Date : August 2006
Estimated Primary Completion Date : August 2010

Resource links provided by the National Library of Medicine


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

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

Biospecimen Retention:   Samples With DNA
Whole blood

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
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.
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00605163


Locations
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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
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ira Shoulson, MD, Principal Investigator, University of Rochester Clinical Trials Coordination Center
ClinicalTrials.gov Identifier: NCT00605163    
Other Study ID Numbers: U01NS050095_PostCEPT
NINDS 5 U01NS050095-02
U01NS050095 ( U.S. NIH Grant/Contract )
First Posted: January 30, 2008    Key Record Dates
Last Update Posted: March 28, 2008
Last Verified: March 2008
Keywords provided by The Parkinson Study Group:
Parkinson disease, observational, longitudinal
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases