NL-OMON56457招募中不适用
The Parkinson*s Progression Markers Initiative (PPMI) Clinical - Establishing a Deeply Phenotyped PD Cohort - PPMI Clinical
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 75
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- 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
- •- Confirmation that participant is eligible based on Screening DaTscan imaging.
- •- Able to provide informed consent.
- •- Either is male, or is female and meets additional criteria below, as
- •applicable:
- •- Female of childbearing potential who is not pregnant, lactating or planning
- •pregnancy during the study and has a negative pregnancy test on day of
- •Screening DaTscan imaging test prior to injection of DaTscanTM.
- •Health controls for prodromal cohort
- •For Screening:
- •- Confirmation that participant is eligible based on centrally determined
- •predictive criteria, i.e., meeting one of the following criteria:
- •- Generalized risk, i.e., first degree biologic relative (parents, siblings)
- •with PD; or
- •- Known risk of PD including RBD; or
- •- Known genetic variants associated with PD risk, i.e., LRRK2, GBA, SNCA or
- •rare genetic variants (such as Parkin or Pink1).
- •In addition, the participant needs a positive indication of Olfactory loss with
- •the University of Pennsylvania Smell Identification Test (UPSIT), performed
- •during the Screening visit, prior to DaTscan.
- •- Male or female.
- •- Age 60 years or older (except age 30 years or older for SNCA, or rare genetic
- •variants (such as Parkin or Pink1) participants).
- •- 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
- •- Able to provide informed consent.
- •For ST Direct participation (as recruitment strategy for the prodromal cohort):
- •- Male or female
- •- Age 60 years or older
- •- No diagnosis of Parkinson's disease
- •- Living in the Netherlands
- •Additional criteria, as applicable:
- •- Female of childbearing potential who is not pregnant, lactating, or planning
- •pregnancy during the study and has a negative pregnancy test on day of
- •Screening DaTscan imaging test prior to injection of DaTscanTM.
- •For continuation to Baseline visit and ongoing follow-up:
- •- Confirmation that participant is eligible based on *Screening DaTscan
排除标准
- •-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).
- •-A clinical diagnosis of dementia as determined by the investigator, at
- •-Previously obtained MRI scan with evidence of clinically significant
- •neurological disorder (in the opinion of the Investigator).
- •-Received any of the following drugs: dopamine receptor blockers
- •(neuroleptics), metoclopramide and reserpine within 6 months of Screening visit.
- •-Current treatment with anticoagulants (e.g., coumadin, heparin, oral thrombin
- •inhibitors) 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.
- •-Any other medical or psychiatric condition or lab abnormality, which in the
- •opinion of the investigator might preclude participation.
- •Healthy controls for prodromal cohort:
- •- Clinical diagnosis of PD, other parkinsonism, or dementia.
- •- Received any of the following drugs: dopamine receptor blockers
- •(neuroleptics), metoclopramide and reserpine within 6 months of Screening Visit.
- •- 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.
- •- Any other medical or psychiatric condition or lab abnormality, which in the
- •opinion of the investigator might preclude participation.
- •- Implants (such as dentals) or metal splinters in upper body that are not
- •allowed to undergo a MRI scan.
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