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

March 26, 2008 updated by: The Parkinson Study Group
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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

530

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • University of Calgary
      • Edmonton, Alberta, Canada
        • University of Alberta
    • Ontario
      • London, Ontario, Canada
        • London Health Sciences Centre
      • Ottawa, Ontario, Canada
        • Ottawa Hospital Civic Site
      • Toronto, Ontario, Canada
        • Toronto Western Hospital, University Health Network
    • Quebec
      • Fleurimont, Quebec, Canada
        • University of Sherbrooke
      • Montreal, Quebec, Canada
        • Hotel-Dieu Hospital-CHUM
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada
        • Saskatoon Disrict Health Board Royal University Hospital
  • United States
    • Arizona
      • Phoenix, Arizona, United States
        • Barrow Neurological Institute
      • Sun City, Arizona, United States
        • Sun Health Research Institute
    • Arkansas
      • Little Rock, Arkansas, United States
        • University of Arkansas for Medical Sciences
    • California
      • Fountain Valley, California, United States
        • The Parkinson's & Movement Disorder Institute
      • Irvine, California, United States
        • University of California Irvine
      • La Jolla, California, United States
        • University of San Diego
      • Los Angeles, California, United States
        • University of Southern California
      • Oxnard, California, United States
        • Pacific Neuroscience Medical Group
      • Sacramento, California, United States
        • University of California Davis
      • Sunnyvale, California, United States
        • The Parkinson's Institute
    • Colorado
      • Aurora, Colorado, United States
        • University of Colorado Health Sciences Center
      • Littleton, Colorado, United States
        • Colorado Neurological Institute
    • Connecticut
      • New Haven, Connecticut, United States
        • Institute for Neurogenerative Disorders
    • Florida
      • Jacksonville, Florida, United States
        • Mayo Clinic Jacksonville
      • Tampa, Florida, United States
        • University of South Florida
      • Weston, Florida, United States
        • Cleveland Clinic Florida-Weston
    • Georgia
      • Augusta, Georgia, United States
        • Medical College of Georgia
    • Illinois
      • Chicago, Illinois, United States
        • Northwestern University
      • Chicago, Illinois, United States
        • University of Chicago
      • Chicago, Illinois, United States
        • Rush University Medical Center
    • Iowa
      • Iowa City, Iowa, United States
        • University of Iowa
    • Kansas
      • Kansas City, Kansas, United States
        • University of Kansas Medical Center
    • Louisiana
      • Shreveport, Louisiana, United States
        • LSU Health Science Center Shreveport
    • Maryland
      • Baltimore, Maryland, United States
        • University of Maryland School of Medicine
      • Baltimore, Maryland, United States
        • Johns Hopkins University
    • Massachusetts
      • Boston, Massachusetts, United States
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States
        • Boston University
      • Boston, Massachusetts, United States
        • Brigham & Women's Hospital
    • Minnesota
      • Minneapolis, Minnesota, United States
        • University of Minnesota
    • Nebraska
      • Omaha, Nebraska, United States
        • Creighton University
    • New Jersey
      • New Brunswick, New Jersey, United States
        • UMDNJ Robert Wood Johnson Medical School
    • New York
      • Albany, New York, United States
        • Albany Medical College
      • Manhasset, New York, United States
        • North Shore-LIJ Health System
      • New York, New York, United States
        • Columbia University
      • New York, New York, United States
        • Beth Israel Medical Center
      • Rochester, New York, United States
        • University of Rochester
    • North Carolina
      • Durham, North Carolina, United States
        • Duke University Medical Center
    • Ohio
      • Cincinnati, Ohio, United States
        • University of Cincinnati/Cincinnati Children's Hospital
      • Portland, Ohio, United States
        • Oregon Health & Science University
      • Toledo, Ohio, United States
        • Medical University of Ohio
    • Pennsylvania
      • Hershey, Pennsylvania, United States
        • Milton S. Hershey Medical Center
      • Philadelphia, Pennsylvania, United States
        • University of Pennsylvania
    • Rhode Island
      • Warwick, Rhode Island, United States
        • NeuroHealth Parkinson's Disease Movement Disorders Center
    • Tennessee
      • Memphis, Tennessee, United States
        • University of Tennessee-Memphis
    • Texas
      • Houston, Texas, United States
        • Baylor College of Medicine
    • Virginia
      • Charlottesville, Virginia, United States
        • University of Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Parkinson disease patients who participated in the PRECEPT clinical trial.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
University of Pennsylvania Smell Identification Test (UPSIT)
Time Frame: Annual, ongoing assessments
Annual, ongoing assessments

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Parkinson Study Group

Collaborators

H. Lundbeck A/S
National Institute of Neurological Disorders and Stroke (NINDS)
United States Department of Defense
Parkinson's Disease Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (Anticipated)

August 1, 2010

Study Registration Dates

First Submitted

January 17, 2008

First Submitted That Met QC Criteria

January 17, 2008

First Posted (Estimate)

January 30, 2008

Study Record Updates

Last Update Posted (Estimate)

March 28, 2008

Last Update Submitted That Met QC Criteria

March 26, 2008

Last Verified

March 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U01NS050095_PostCEPT
  • NINDS 5 U01NS050095-02
  • U01NS050095 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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