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

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
H. Lundbeck A/S
Parkinson's Disease Foundation
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
  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:


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
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 ClinicalTrials.gov identifier: NCT00605163

  Hide Study Locations
Locations
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
United States, California
The Parkinson's & Movement Disorder Institute
Fountain Valley, California, United States
University of California Irvine
Irvine, California, United States
University of San Diego
La Jolla, California, United States
University of Southern California
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
United States, Colorado
University of Colorado Health Sciences Center
Aurora, Colorado, United States
Colorado Neurological Institute
Littleton, Colorado, United States
United States, Connecticut
Institute for Neurogenerative Disorders
New Haven, Connecticut, United States
United States, Florida
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
University of South Florida
Tampa, Florida, United States
Cleveland Clinic Florida-Weston
Weston, Florida, United States
United States, Georgia
Medical College of Georgia
Augusta, Georgia, United States
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Northwestern University
Chicago, Illinois, United States
United States, Iowa
University of Iowa
Iowa City, Iowa, United States
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States
United States, Louisiana
LSU Health Science Center Shreveport
Shreveport, Louisiana, United States
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States
University of Maryland School of Medicine
Baltimore, Maryland, United States
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States
Boston University
Boston, Massachusetts, United States
Brigham & Women's Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States
United States, Nebraska
Creighton University
Omaha, Nebraska, United States
United States, New Jersey
UMDNJ Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
United States, New York
Albany Medical College
Albany, New York, United States
North Shore-LIJ Health System
Manhasset, New York, United States
Columbia University
New York, New York, United States
Beth Israel Medical Center
New York, New York, United States
University of Rochester
Rochester, New York, United States
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States
United States, Ohio
University of Cincinnati/Cincinnati Children's Hospital
Cincinnati, Ohio, United States
Oregon Health & Science University
Portland, Ohio, United States
Medical University of Ohio
Toledo, Ohio, United States
United States, Pennsylvania
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
United States, Texas
Baylor College of Medicine
Houston, Texas, United States
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States
Canada, Alberta
University of Calgary
Calgary, Alberta, Canada
University of Alberta
Edmonton, Alberta, Canada
Canada, Ontario
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
H. Lundbeck A/S
Parkinson's Disease Foundation
  More Information

Additional Information:
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 September 18, 2014