NL-OMON56457
Recruiting
Not Applicable
The Parkinson*s Progression Markers Initiative (PPMI) Clinical - Establishing a Deeply Phenotyped PD Cohort - PPMI Clinical
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Michael J Fox Foundation
- Enrollment
- 75
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Male or female age 30 years or older at Screening Visit.
- •\- A diagnosis of Parkinson disease for 2 years or less at Screening Visit.
- •\- Not expected to require PD medication within at least 6 months from
- •\- 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.
- •\- Hoehn and Yahr stage I or II at Baseline.
- •\- Individuals taking any of the following drugs: alpha methyldopa,
- •methylphenidate, amphetamine derivatives or modafinil, must be willing and
- •medically able to hold the medication for at least 5 half \-lives before DaTscan
Exclusion Criteria
- •\-Currently taking levodopa, dopamine agonists, MAO\-B inhibitors (e.g.,
- •selegiline, rasagiline), amantadine or another PD medication, except for
- •low\-dose treatment of restless leg syndrome.
- •\-Has taken levodopa, dopamine agonists, MAO\-B inhibitors or amantadine within
- •60 days of Baseline visit, except for low\-dose treatment of restless leg
- •\- Has taken levodopa or dopamine agonists prior to Baseline visit for more than
- •a total of 90 days.
- •\-Atypical PD syndromes due to either drugs (e.g., metoclopramide, flunarizine,
- •neuroleptics) or metabolic disorders (e.g., Wilson\*s disease), encephalitis, or
- •degenerative diseases (e.g., progressive supranuclear palsy).
Outcomes
Primary Outcomes
Not specified
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