A Longitudinal Observational Follow-up of the PRECEPT Study Cohort

Parkinson Disease Clinical Trial

— PostCEPT  

Official title:

A Longitudinal Observational Follow-up of the PRECEPT Study Cohort

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT00605163
• Other study ID #: U01NS050095_PostCEPT
• Secondary ID: NINDS 5 U01NS050
• Status: Enrolling by invitation
• Phase: N/A
• First received: January 17, 2008
• Last updated: March 26, 2008
• Start date: August 2006

Study information

• Verified date: March 2008
• Source: The Parkinson Study Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 530
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

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 Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Parkinson Disease

Locations

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

Sponsors (5)

Lead Sponsor	Collaborator
The Parkinson Study Group	H. Lundbeck A/S, National Institute of Neurological Disorders and Stroke (NINDS), Parkinson's Disease Foundation, United States Department of Defense

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

Parkinson Study Group PRECEPT Investigators. Mixed lineage kinase inhibitor CEP-1347 fails to delay disability in early Parkinson disease. Neurology. 2007 Oct 9;69(15):1480-90. Epub 2007 Sep 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Unified Parkinson Disease Rating Scale (UPDRS) and ß-CIT SPECT imaging of the dopamine transporter.		Annual, ongoing assessments	No
Secondary	University of Pennsylvania Smell Identification Test (UPSIT)		Annual, ongoing assessments	No

External Links

•   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.