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Official Study Title: The Parkinson’s Progression Markers Initiative (PPMI)
Sponsor: Michael J. Fox Foundation for Parkinson's Research
Clinicaltrials.gov ID: NCT01141023
Study ID: PPMI 001

Summary

This is an observational,  Observational TrialFocused on understanding more about a disease, which is critical to developing new treatments, therapies, or preventions. These trials involve no intervention, but may include genetic studies of families with a history of Parkinson's, measurement of brain or motor activity, or studies of environmental factors associated with a disease. multi-center study to assess progression of clinical  ClinicalDealing with or based on observation and treatment of people, as opposed to basic science carried out in the laboratory or in animals. features, imaging and biologic markers in Parkinson’s disease (PD) patients and healthy controls.  The primary objective of this study is to identify clinical, imaging and biologic markers of PD progression for use in clinical trials of therapies that address the disease itself, not just symptoms (disease-modifying therapies).   The defining motor features of PD are characterized by their subtle onset and unstoppable but variable progression.  Reliable and well-validated biomarkers to monitor PD progression would dramatically improve patient care and accelerate research into both PD etiology and therapeutics.  During the past two decades much progress has been made in identifying and assessing PD biomarkers, but as yet no fully validated biomarker for PD is currently available.

A primary outcome of this study is the rate of change in clinical, imaging and biomic outcomes in early PD patients at study intervals from three months to 36 months, and where appropriate comparing this rate of change in PD patient subsets and between people with PD and people without PD at study intervals from three months to 36 months.  Some examples of outcomes measures include MDS-UPDRS, DAT imaging results, and blood and CSF samples. PD patient subsets may be defined by baseline  BaselinBeginning measurements against which a participant’s progress can be quantified at the end of a study. assessments, changes in progression and/or rate of clinical, imaging, or biomic change.

Study Phase

Not Applicable
What is a study phase?

Time Commitment

• More than six months
• Visits every three months for the first year, and every six months for the remaining four years

Eligibility

• Minimum Age: 30
• Gender(s) Accepted: Either
• Maximum Years Since Diagnosis: 2
• Study is enrolling non-PD participants

Inclusion Criteria

People With Parkinson's

• A diagnosis of PD for two years or less at screening.  ScreeningPeriod of selection of clinical trial participants based on ELIGIBILITY CRITERIA.
• Not expected to require PD medication with at least six months from baseline.

Exclusion Criteria

People With Parkinson's

• Currently taking levodopa,  LevodopaA compound that is converted into dopamine (the brain chemical which is deficient in people with Parkinson's) in the brain. dopamine  DopamineA "chemical messenger" that regulates movement by assisting in the effective communication (transmission) of electrochemical signals in the brain from one nerve cell (neuron) to another. As dopamine producing cells degenerate with advancing PD, they no longer produce enough to regulate neurons elsewhere in the brain, resulting in a loss of control of movements, leading to symptoms such as slowed movements, tremor, and rigidity. agonists, MAO-B inhibitors, amantadine or other PD medication.
• Has taken levodopa, dopamine agonists, MAO-B inhibitors or amantadine within 60 days of baseline.
• Has taken levodopa or dopamine agonists prior to baseline for more than a total of 60 days.
• Received any of the following drugs that might interfere with DAT imaging: neuroleptics, metoclopramide, alpha methyldopa, methylphenidate, reserpine, or amphetamine derivative, within six months of screening.
• Current treatment with anticoagulants (e.g., coumadin, heparin) that might preclude safe completion of the lumbar puncture.
• Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia.
• Use of investigational drugs within 60 days prior to baseline (dietary supplements taken outside of a clinical trial  Clinical Trial (Clinical Study)A scientific study involving human participants to determine the safety and efficacy of new therapies or new ways of using known treatments. are not exclusionary, e.g., coenzyme Q10)  Coenzyme Q10An enzyme that improves the function of the "powerhouses" (mitochondria) that produce energy in cells and "mops up" potentially harmful chemicals generated during normal metabolism. People with Parkinson’s have low levels of this potent antioxidant in mitochondria and exhibit impaired mitochondrial function. Levels can be increased by taking CoQ10 supplements, although clinical trial results are not clear that this is beneficial. .

People Without Parkinson's

• Current or active neurological disorder.
• First degree relative with idiopathic  IdiopathicOf, relating to, or designating a disease having no known cause. PD (parent, sibling, child).
• Received any of the following drugs that might interfere with DAT imaging: neuroleptics, metoclopramide, alpha methyldopa, methylphenidate, reserpine, or amphetamine derivative, within six months of screening.
• Current treatment with anticoagulants (e.g., coumadin, heparin) that might preclude safe completion of the lumbar puncture.
• Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia.
• Use of other investigational drugs within 60 days prior to baseline (dietary supplements taken outside of a clinical trial are not exclusionary, e.g., coenzyme Q10).

Enrollment

Expected Enrollment: 600 (US)
Date Enrollment Began: Jun 2010
Date Enrollment Ends: Sep 2012
Last Updated Date: Aug 20 2010
Trial Post Date: Jun 18 2010
Website: http://www.michaeljfox.org/research_PPMI.cfm

Primary Contacts and Locations

Connecticut

• Shirley Lasch
  Institute for Neurodegenerative Disorders
  slasch@indd.org
  Phone: (877) 525-7764
  60 Temple Street
  New Haven, CT 06510
  USA
  

New York

• Emily Flagg
  Clinical Trials Coordination Center
  emily.flagg@ctcc.rochester.edu
  Phone: (877) 525-7764
  1351 Mt. Hope Avenue
  Ste. 223
  Rochester, NY 14620
  USA
  

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