The Parkinson's Progression Markers Initiative (PPMI) - PPMI

MICHAEL J. FOX FOUNDATION FOR PARKINSON'S RESEARCH0 sites600 target enrollmentMarch 2, 2012

ConditionsParkinson Disease MedDRA version: 14.1Level: PTClassification code 10061536Term: Parkinson's diseaseSystem Organ Class: 10029205 - Nervous system disorders Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

DrugsDaTSCAN

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Parkinson Disease
Sponsor: MICHAEL J. FOX FOUNDATION FOR PARKINSON'S RESEARCH
Enrollment: 600
Status: Active, not recruiting
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

March 2, 2012

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

MICHAEL J. FOX FOUNDATION FOR PARKINSON'S RESEARCH

Eligibility Criteria

Inclusion Criteria

•Parkinson Disease(PD)Subjects: 1\.Patients must have at least two of the following: resting tremor, bradykinesia, rigidity (must have either resting tremor or bradykinesia); OR either asymmetric resting tremor or asymmetric bradykinesia. 2\.A diagnosis of Parkinson disease for two years or less at Screening. 3\.Hoehn and Yahr stage I or II. 4\.Confirmation from imaging core that screening DAT scan is consistent with dopamine transporter deficit. 5\.Not expected to require PD medication with at least 6 months from Baseline. 6\.Male or female age 30 years or older at time of PD diagnosis. Healthy Control (HC)Subjects: 1\.Male or female age 30 years or older at Screening. 2\.Confirmation from imaging core that screening DAT scan is consistent with no dopamine transporter deficit.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 300
•F.1\.3 Elderly (\>\=65 years) yes
•F.1\.3\.1 Number of subjects for this age range 300

Exclusion Criteria

•Parkinson Disease (PD) Subjects: 1\.Currently taking levodopa, dopamine agonists, MAO\-B inhibitors, amantadine or other PD medication. 2\.Has taken levodopa, dopamine agonists, MAO\-B inhibitors or amantadine within 60 days of Baseline. 3\.Has taken levodopa or dopamine agonists prior to Baseline for more than a total of 60 days. 4\.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. 5\.Current treatment with anticoagulants (e.g., coumadin, heparin) that might preclude safe completion of the lumbar puncture. 6\.Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia. 7\.Use of investigational drugs or devices 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: 1\.Current or active neurological disorder. 2\.First degree relative with idiopathic PD (parent, sibling, child). 3\.MoCA score \= 26\. 4\.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. 5\.Current treatment with anticoagulants (e.g., coumadin, heparin) that might preclude safe completion of the lumbar puncture. 6\.Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia. 7\.Use of investigational drugs or devices within 60 days prior to baseline (dietary supplements taken outside of a clinical trial are not exclusionary, e.g., coenzyme Q10\).