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

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
National Institute of Neurological Disorders and Stroke (NINDS)
H. Lundbeck A/S
Parkinson's Disease Foundation
Department of Defense
Information provided by:
The Parkinson Study Group
ClinicalTrials.gov Identifier:
NCT00605163
First received: January 17, 2008
Last updated: March 26, 2008
Last verified: March 2008
History of Changes
  Purpose

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
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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • University of Pennsylvania Smell Identification Test (UPSIT) [ Time Frame: Annual, ongoing assessments ] [ Designated as safety issue: No ]

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)
  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00605163

  Show 55 Study Locations
Sponsors and Collaborators
The Parkinson Study Group
National Institute of Neurological Disorders and Stroke (NINDS)
H. Lundbeck A/S
Parkinson's Disease Foundation
Department of Defense
  More Information

Additional Information:
The Parkinson Study Group (PSG) is a non-profit, cooperative group of Parkinson's disease experts from medical centers in theUnited States and Canada who are dedicated to improving treatment for persons affected by Parkinson's disease.  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Ira Shoulson, MD, Principal Investigator, University of Rochester Clinical Trials Coordination Center
ClinicalTrials.gov Identifier: NCT00605163     History of Changes
Other Study ID Numbers: U01NS050095_PostCEPT, NINDS 5 U01NS050095-02
Study First Received: January 17, 2008
Last Updated: March 26, 2008
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 22, 2013