Clinical trial NCT00605163: A Longitudinal Observational Follow-up of the PRECEPT Study Cohort
Official title: A Longitudinal Observational Follow-up of the PRECEPT Study Cohort
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Parkinson Disease
Keywords: Parkinson disease, observational, longitudinal
Lead sponsor: The Parkinson Study Group
Sponsor class: NETWORK
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
name: H. Lundbeck A/S
name: Parkinson's Disease Foundation
name: United States Department of Defense
First posted: 2008-01-30
Enrollment: 530
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parkinson disease patients who participated in the PRECEPT clinical trial.

Brief 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.


Eligibility 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

Primary outcomes:
measure: Unified Parkinson Disease Rating Scale (UPDRS) and β-CIT SPECT imaging of the dopamine transporter.
timeFrame: Annual, ongoing assessments
Secondary outcomes:
measure: University of Pennsylvania Smell Identification Test (UPSIT)
timeFrame: Annual, ongoing assessments
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Barrow Neurological Institute
state: Arizona
city: Sun City
country: United States
facility: Sun Health Research Institute
state: Arizona
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: Fountain Valley
country: United States
facility: The Parkinson's & Movement Disorder Institute
state: California
city: Irvine
country: United States
facility: University of California Irvine
state: California
city: La Jolla
country: United States
facility: University of San Diego
state: California
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Oxnard
country: United States
facility: Pacific Neuroscience Medical Group
state: California
city: Sacramento
country: United States
facility: University of California Davis
state: California
city: Sunnyvale
country: United States
facility: The Parkinson's Institute
state: California
city: Aurora
country: United States
facility: University of Colorado Health Sciences Center
state: Colorado
city: Littleton
country: United States
facility: Colorado Neurological Institute
state: Colorado
city: New Haven
country: United States
facility: Institute for Neurogenerative Disorders
state: Connecticut
city: Jacksonville
country: United States
facility: Mayo Clinic Jacksonville
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Weston
country: United States
facility: Cleveland Clinic Florida-Weston
state: Florida
city: Augusta
country: United States
facility: Medical College of Georgia
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Shreveport
country: United States
facility: LSU Health Science Center Shreveport
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Baltimore
country: United States
facility: University of Maryland School of Medicine
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Boston University
state: Massachusetts
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Omaha
country: United States
facility: Creighton University
state: Nebraska
city: New Brunswick
country: United States
facility: UMDNJ Robert Wood Johnson Medical School
state: New Jersey
city: Albany
country: United States
facility: Albany Medical College
state: New York
city: Manhasset
country: United States
facility: North Shore-LIJ Health System
state: New York
city: New York
country: United States
facility: Beth Israel Medical Center
state: New York
city: New York
country: United States
facility: Columbia University
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati/Cincinnati Children's Hospital
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University
state: Ohio
city: Toledo
country: United States
facility: Medical University of Ohio
state: Ohio
city: Hershey
country: United States
facility: Milton S. Hershey Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Warwick
country: United States
facility: NeuroHealth Parkinson's Disease Movement Disorders Center
state: Rhode Island
city: Memphis
country: United States
facility: University of Tennessee-Memphis
state: Tennessee
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital Civic Site
state: Ontario
city: Toronto
country: Canada
facility: Toronto Western Hospital, University Health Network
state: Ontario
city: Fleurimont
country: Canada
facility: University of Sherbrooke
state: Quebec
city: Montreal
country: Canada
facility: Hotel-Dieu Hospital-CHUM
state: Quebec
city: Saskatoon
country: Canada
facility: Saskatoon Disrict Health Board Royal University Hospital
state: Saskatchewan
Study officials:
References:
citation: 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. doi: 10.1212/01.wnl.0000277648.63931.c0. Epub 2007 Sep 19.
citation: Latourelle JC, Beste MT, Hadzi TC, Miller RE, Oppenheim JN, Valko MP, Wuest DM, Church BW, Khalil IG, Hayete B, Venuto CS. Large-scale identification of clinical and genetic predictors of motor progression in patients with newly diagnosed Parkinson's disease: a longitudinal cohort study and validation. Lancet Neurol. 2017 Nov;16(11):908-916. doi: 10.1016/S1474-4422(17)30328-9. Epub 2017 Sep 25.