Study to Identify Clinical, Imaging and Biologic Markers of Parkinson Disease Progression

Completed · Phase 2

Conditions studied: Parkinson Disease

In brief

This is a observational, multi-center study to assess progression of clinical features, imaging and biologic biomarkers in Parkinson disease (PD) patients compared to healthy controls (HC) and in PD patient subtypes. The primary objective of this study is to identify clinical, imaging and biologic markers of PD progression for use in clinical trials of disease-modifying therapies.

Key facts

Study ID

NCT01141023

Run by

Ken Marek, MD

People needed

952

Starts

2010-06-01

Expected to finish

2020-06-30

Last updated by the study team

2023-11-14

Who can join

Age: 30 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Parkinson Disease (PD) Subjects:
• A diagnosis of Parkinson disease for 2 years or less at Screening.
• Confirmation from imaging core that screening DAT scan is consistent with dopamine transporter deficit, or if applicable a VMAT-2 PET scan consistent with vesicular monoamine transporter deficit.
• Not expected to require PD medication with at least 6 months from Baseline.
• Male or female age 30 years or older at time of PD diagnosis.
• Healthy Control (HC) Subjects:
• Male or female age 30 years or older at Screening.

You may not qualify if…

• Parkinson Disease (PD) Subjects:
• Currently taking levodopa, dopamine 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 6 months of Screening.
• Current treatment with anticoagulants (e.g., coumadin, heparin) that might preclude safe completion of the lumbar puncture.
• If applicable, currently taking medications that are known to cause QT-prolongation, or are currently taking tetrabenazine (TBZ or amphetamine type medications.
• 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 are not exclusionary, e.g., coenzyme Q10).
• Healthy Control (HC) Subjects:
• Current or active neurological disorder.
• First degree relative with idiopathic PD (parent, sibling, child).
• MoCA score < 26.
• Received any of the following drugs that might interfere with DAT imaging: Neuroleptics, metoclopramide, alpha methyldopa, methylphenidate, reserpine, or amphetamine derivative, within 6 months of Screening.
• If applicable, currently taking medications that are known to cause QT-prolongation, or are currently taking tetrabenazine (TBZ) or amphetamine type medications.
• 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).
• SWEDD Subjects:
• All PD criteria apply, as above, except a SWEDD subject must have confirmation from imaging core that screening dopamine transporter SPECT scan shows no evidence of dopamine transporter deficit or if applicable a VMAT-2 PET scan shows no evidence of vesicular monoamine transporter deficit.
• Prodromal Subjects:
• Inclusion Criteria (Prodromal Subjects) 4.2.7.1. Subjects must have at least one of the following characteristics:
• Hyposmia:
• Male or female age 60 years or older
• Confirmation from olfactory core that olfaction as determined by UPSIT is at or below the 10th percentile by age and gender

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Banner Research Institute — Sun City, Arizona, United States
• University of California San Diego — La Jolla, California, United States
• University of California, San Francisco — San Francisco, California, United States
• The Parkinson's Institute — Sunnyvale, California, United States
• Institute For Neurodegenerative Disorders — New Haven, Connecticut, United States
• Parkinson's Disease& Movement Disorder Center of Boca Raton — Boca Raton, Florida, United States
• University of South Florida — Tampa, Florida, United States
• Emory University School of Medicine — Atlanta, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• John Hopkins University — Baltimore, Maryland, United States
• Boston University — Boston, Massachusetts, United States
• Beth Israel Medical Center — New York, New York, United States
• Columbia University Medical Center — New York, New York, United States
• University of Rochester — Rochester, New York, United States
• University of Cincinnati/Cincinnati Children's Hospital — Cincinnati, Ohio, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Oregon Health &Science University — Portland, Oregon, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Baylor College of Medicine — Houston, Texas, United States
• Univ of Washington and VA Puget Sound Health Care System — Seattle, Washington, United States
• Macquarie University — Sydney, Australia
• Innsbruck Medical University — Innsbruck, Austria
• Hospital Pitie-Salpetriere — Paris, France
• Paracelsus-Elena Klinik — Kassel, Germany

Full record on ClinicalTrials.gov

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