A Longitudinal Observational Follow-up of the PRECEPT Study Cohort - Full Text View

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

This study is enrolling participants by invitation only.

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
Information provided by:	The Parkinson Study Group
ClinicalTrials.gov Identifier:	NCT00605163

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

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics: Parkinson's Disease

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort
Official Title:	A Longitudinal Observational Follow-up of the PRECEPT Study Cohort

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

Biospecimen Description:

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

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

This link exits the ClinicalTrials.gov site

Publications:

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.

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

Keywords provided by The Parkinson Study Group:

Parkinson disease, observational, longitudinal

Study placed in the following topic categories:

Ganglion Cysts
Movement Disorders
Parkinson Disease
Basal Ganglia Diseases

Central Nervous System Diseases
Parkinsonian Disorders
Neurodegenerative Diseases
Brain Diseases

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 14, 2009