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Parkinson's Disease Biomarker Program (PDBP)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01767818
First Posted: January 14, 2013
Last Update Posted: December 29, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center
  Purpose
The primary objective of this study is to obtain detailed clinical information and biologic specimens from subjects with PD toward the ultimate end of identifying a biomarker of PD. Because of the inherent difficulties of using clinical outcome measures to assess disease modification, the identification of biomarkers of PD is of paramount importance. The ideal PD biomarker would be one that is easily assayed in a convenient biological sample, varies proportionally with disease severity, is abnormal during the pre-symptomatic phase of the illness, and is unaffected by drugs or other interventions used to treat PD. The existence of a sensitive biomarker with these properties would enable much more effective disease modifying research that would likely be able to take advantage of smaller and potentially shorter trials.

Condition
Parkinson's Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Longitudinal, Single-center Prospective Study to Assess Progression of Clinical Features and Biologic Markers of Parkinson's Disease Subjects of Varying Levels of Disease Severity

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • To estimate the mean rates of change and the variability around the mean of clinical outcomes in PD patients over 3-5 years of follow-up comparing these rates between PD patients of each stage of the Hoehn and Yahr. [ Time Frame: 5 years ]

Secondary Outcome Measures:
  • To determine the predictive value of iTUG/iSWAY test results on future course of the disease [ Time Frame: 5 years ]

Biospecimen Retention:   Samples With DNA
Blood specimen collection from all enrolled patients and cerebrospinal fluid (CSF) from patients who have provided additional and optional consent to CSF collection.

Estimated Enrollment: 240
Study Start Date: November 2012
Estimated Study Completion Date: September 2019
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Previously treated PD patients
220 subjects with PD treated and responsive to dopaminergic medication
Previously untreated PD
20 subjects with de-novo, previously untreated PD confirmed by I-123 Ioflupane SPECT
Healthy age-matched controls
46 age-matched healthy controls will be studied.

Detailed Description:
Subjects will be asked to attend study visits every 6 months for up to 5 years of follow up. Each visit will consist of patient outcomes questionnaires, neurological exams, computerized assessments of gait and balance, a video recorded motor exam, and biological specimen collection for biomarker discovery.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
(1) de-novo, previously untreated patients within 5 years of symptom onset, n=20, and (2) patients on treatment with and clinically responsive to MAO-B inhibitors, dopamine agonists, amantadine, or levodopa (or combinations), n=220 and (3) healthy control patients without evidence of degenerative nerological disease.
Criteria

Inclusion Criteria:

  • A diagnosis of idiopathic PD meeting UK PD Society Brain Bank Criteria (Step 1, Step 2, and 2 items present from step 3).1
  • Male or female age 30 years or older at time of PD diagnosis, Hoehn & Yahr (H&Y) stage I-IV.
  • Confirmation from I-123 Ioflupane SPECT (DatScan®) of dopamine transporter deficit for de-novo, untreated patients.
  • Clinical evidence of response to dopaminergic medication (MAO-B inhibitors, dopamine agonists, levodopa, or combinations) in patients on treatment for PD.
  • Ability to provide written informed consent in accordance with Good Clinical Practice (GCP), International Conference on Harmonization (ICH), and local regulations.
  • Able to make visits to UT Southwestern every 6 months for up to 5 years without undue hardship.

Exclusion Criteria:

  • Idiopathic PD, H&Y stage 5, as these will be unable to participate in gait assessments.
  • Confirmed or suspected atypical parkinsonian syndromes due to drugs, metabolic disorders, encephalitis, or degenerative diseases.
  • Presence of definite dementia (MoCA < 17)2.
  • For de-novo subjects: received any of the following drugs that might interfere with dopamine transporter SPECT imaging: neuroleptics, metoclopramide, alpha methyldopa, methylphenidate, reserpine, or amphetamine derivative, within 6 months of screening.
  • For the prospective CSF cohort: current treatment with anticoagulants (e.g., coumadin, heparin) that might preclude safe completion of the lumbar puncture.
  • For the prospective CSF cohort: any condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or known clinically significant coagulopathy or thrombocytopenia.
  • Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01767818


Locations
United States, Texas
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
Principal Investigator: Richard Dewey, MD UT Southwestern Medical Center
  More Information

Additional Information:
Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01767818     History of Changes
Other Study ID Numbers: NS-12-011
1U01NS082148-01 ( U.S. NIH Grant/Contract )
First Submitted: January 7, 2013
First Posted: January 14, 2013
Last Update Posted: December 29, 2016
Last Verified: December 2016

Keywords provided by University of Texas Southwestern Medical Center:
Parkinson's Disease

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases


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