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Trial record 23 of 81427 for:    measured

Measuring Parkinson's Disease Progression (MPDP)

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ClinicalTrials.gov Identifier: NCT03205956
Recruitment Status : Recruiting
First Posted : July 2, 2017
Last Update Posted : March 26, 2019
Sponsor:
Collaborator:
The Michael J. Fox Foundation for Parkinson's Research
Information provided by (Responsible Party):
Kevin J. Black, MD, Washington University School of Medicine

Brief Summary:
The Measuring Parkinson's Disease Progression study aims to use MRI scans and a controlled dose of levodopa to find a biomarker (objective measurement) of Parkinson's disease (PD). Biomarkers would help determine the effectiveness of therapies in slowing or stopping PD progression, and accelerate the pace of research.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: Levodopa Phase 1

Detailed Description:
Early in the course of Parkinson's disease, a small dose of levodopa (L-DOPA) provides benefit for many hours. The body responds as if the levodopa in the plasma filled a reservoir and then slowly leaked out to produce benefit. With disease progression, even though the same amount of levodopa circulates in the blood, the benefit wears off much faster, as if the reservoir had become leakier. This wearing off of benefit can be characterized by a single number, the effect site rate constant Ke. On average, patients with more severe disease and longer disease duration have a larger ("leakier") Ke when the response to drug is measured using clinical features like tapping speed. Unfortunately, clinical measurements are influenced by confounding factors such as patient fatigue and comfort. A direct, objective brain measure of response to levodopa may improve the reliability of this measurement. Fortunately, we can assess the effect of levodopa on the brain directly, using an MRI machine to measure blood flow in different parts of the brain. For instance, the midbrain has a robust blood flow response to a single, clinically sensible dose of levodopa. This study's goal is to validate MRI measurement of Ke in the brain as an objective, quantitative measure of disease severity in PD. We will do this by comparing MRI-based Ke values from people with PD across a wide range of disease duration and severity. In a subgroup of participants, we will do this measurement twice, once before treatment and once after 6 weeks of treatment with carbidopa-levodopa (Sinemet® and other brand names).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Intervention Model Description: All participants receive oral carbidopa before, and i.v. levodopa during brain imaging, to measure regional cerebral blood flow responses to levodopa.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Dopamine Buffering Capacity Measured by phMRI as a Novel Biomarker of Disease Progression in PD
Actual Study Start Date : October 19, 2017
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PD Group
A broad range of Parkinson's disease severity and disease duration. Some subjects will not be treated currently with levodopa, and thus likely will be early in the disease process.
Drug: Levodopa

At least 1 hour after 200mg carbidopa p.o., each subject will receive an intravenous solution of levodopa in saline at a rate based on age and body mass according to the "final dose" described in Black et al 2003.The total dose for a 70-year-old, 70kg subject will be approximately 65mg.

Subjects with untreated PD will then take 6 ± 1 weeks of clinically dosed oral carbidopa-levodopa tablets for clinical purposes and then repeat the carbidopa plus intravenous levodopa dose as above.

Other Name: Carbidopa




Primary Outcome Measures :
  1. Ke measured by phMRI [ Time Frame: 2 hours ]
    Effect site rate constant measured by serum levodopa concentrations and regional cerebral blood flow. Note, there are no outcome measures relevant to clinical care. This is not a placebo-controlled treatment study.


Secondary Outcome Measures :
  1. Side effect ratings [ Time Frame: 2 hours ]
    Nausea/vomiting, sleepiness, dizziness or lightheadedness, and overall feeling poorly or well, are each measured on a horizontal visual analog scale before and at the end of the i.v. levodopa infusion



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 40-79 at screening
  • Meet accepted diagnostic criteria for Parkinson disease

Exclusion Criteria: Key exclusion criteria:

  • Deep brain stimulator (DBS)
  • Pregnancy
  • Patients taking a dopamine antagonist (like quetiapine) or dopamine partial agonist (like aripiprazole)
  • Metal in the head or eye, or other contraindication to MRI
  • Claustrophobia
  • Serious neurologic disease other than PD
  • Head trauma with loss of consciousness for more than 5 minutes
  • Severe or unstable systemic illness
  • Certain psychiatric illnesses (dementia, psychosis, current major depression)
  • Current alcohol use disorder
  • Subjects who feel that going without nicotine for 3-4 hours would be uncomfortable
  • Currently taking an extended-release formulation of a dopamine agonist (like Mirapex ER or Requip XL)

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): NCT03205956


Contacts
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Contact: Kevin J Black, MD 3143625041 kevin@WUSTL.edu
Contact: Emily C Bihun, M.Ed. 3143622083 emilybihun@wustl.edu

Locations
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United States, Missouri
Washington University School of Medicine, Movement Disorders Center Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Emily C. Bihun, M.Ed.    314-362-2083    EmilyBihun@wustl.edu   
Contact: Kevin J Black, MD    314-362-5041    kevin@WUSTL.edu   
Principal Investigator: Kevin J. Black, MD         
Sponsors and Collaborators
Kevin J. Black, MD
The Michael J. Fox Foundation for Parkinson's Research
Investigators
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Principal Investigator: Kevin J Black, MD Washington University School of Medicine
  Study Documents (Full-Text)

Documents provided by Kevin J. Black, MD, Washington University School of Medicine:

Publications:
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Responsible Party: Kevin J. Black, MD, Professor, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03205956     History of Changes
Other Study ID Numbers: 009
First Posted: July 2, 2017    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We will publicly share a fully anonymized set of linked data from this study. No protected health information (PHI) will be shared.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: Data from Aim 1 shared by 24 months; Data from Aim 2 by 36 months.
Access Criteria: Public
URL: http://www.osf.io/fbn79/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kevin J. Black, MD, Washington University School of Medicine:
Parkinson's disease
PD
levodopa
Additional relevant MeSH terms:
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Parkinson Disease
Disease Progression
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Disease Attributes
Pathologic Processes
Levodopa
Carbidopa
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Aromatic Amino Acid Decarboxylase Inhibitors
Enzyme Inhibitors