| Eligibility |
Non-manifesting LRRK2 mutation carriers
Inclusion:
- Ability to provide informed consent
- Confirmed LRRK2 G2019S mutation
- Age 30 years or older at date of informed consent.
Exclusion:
- Inability to provide informed consent
- Known GBA mutation carrier
- Participation in a blinded clinical trial of any kind or an unblinded trial of an
investigational product that is not currently approved for use in humans. Participants
that have had a 6 - month washout period between ending participation in a clinical
trial with an investigational agent and enrollment into the ECV-004 study are
eligible.
- The presence of rest tremor, bradykinesia or rigidity.
- The presence of any other neurological sign that in the opinion of the site
investigator raises suspicion for an atypical parkinsonian syndrome (e.g. supranuclear
gaze palsy)
- Treatment for cancer in the last 5 years or cancer patient receiving immunotherapy or
targeted therapy. Individuals with cancers that have not been treated with systemic
chemotherapy, immunotherapy, targeted therapies or radiation therapy are eligible to
enroll in the study.
- Diagnosis of an autoimmune disorder
- Current treatment with anticoagulants that might preclude safe completion of the
lumbar puncture and that cannot be safely paused in the opinion of the site
investigator.
- Any condition that, in the investigator's opinion, precludes the safe performance of
routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding
diathesis, or clinically significant coagulopathy or thrombocytopenia.
- Diagnosis of dementia
- Pregnant females, if fluoroscopy is needed to obtain the spinal fluid sample
LRRK2 Parkinson Disease (PD) Participants:
Inclusion:
- Ability to provide informed consent
- Confirmed LRRK2 G2019S mutation
- Meet the MDS criteria for Parkinson's disease
- Disease duration: any
- Age 30 years or older at time of PD diagnosis.
Exclusion:
- Known GBA mutation carrier
- Participation in a blinded clinical trial of any kind or an unblinded trial of an
investigational product that is not currently approved for use in humans. Participants
that have had a 6 - month washout period between ending participation in a clinical
trial with an investigational agent and enrollment into the ECV-004 study are
eligible.
- Treatment for cancer in the last 5 years or cancer patient receiving immunotherapy or
targeted therapy. Individuals with cancers that have not been treated with systemic
chemotherapy, immunotherapy, targeted therapies or radiation therapy are eligible to
enroll in the study.
- Diagnosis of an autoimmune disorder
- Current treatment with anticoagulants that might preclude safe completion of the
lumbar puncture and that cannot be safely paused in the opinion of the site
investigator.
- Any condition that, in the investigator's opinion, precludes the safe performance of
routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding
diathesis, or clinically significant coagulopathy or thrombocytopenia.
- Diagnosis of dementia
- Pregnant females, if fluoroscopy is needed to obtain the spinal fluid sample
Idiopathic PD (iPD) Particpants:
Inclusion:
- Ability to provide informed consent
- Meet the MDS criteria for Parkinson's disease.
- Disease duration: any
- Age 30 years or older at time of PD diagnosis.
Exclusion:
- Known LRRK2 G2019S and/or GBA mutation carrier
- Participation in a blinded clinical trial of any kind or an unblinded trial of an
investigational product that is not currently approved for use in humans. Participants
that have had a 6 - month washout period between ending participation in a clinical
trial with an investigational agent and enrollment into the ECV-004 study are
eligible.
- Treatment for cancer in the last 5 years or cancer patient receiving immunotherapy or
targeted therapy. Individuals with cancers that have not been treated with systemic
chemotherapy, immunotherapy, targeted therapies or radiation therapy are eligible to
enroll in the study.
- Diagnosis of an autoimmune disorder
- Current treatment with anticoagulants that might preclude safe completion of the
lumbar puncture and that cannot be safely paused in the opinion of the site
investigator.
- Any condition that, in the investigator's opinion, precludes the safe performance of
routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding
diathesis, or clinically significant coagulopathy or thrombocytopenia.
- Diagnosis of dementia
- Pregnant females, if fluoroscopy is needed to obtain the spinal fluid sample
Control (C) Participants:
Inclusion:
- Ability to provide informed consent
- Age 30 years or older at date of informed consent.
Exclusion:
- Known GBA mutation carrier
- In the absence of prior genetic testing for LRRK2 G2019S mutations: Family history of
Parkinson's disease is an exclusion criterion. If genetic testing for LRRK2 G2019S
mutations has been performed and is negative, individuals with a family history of PD
may be enrolled.
- The presence of rest tremor, bradykinesia or rigidity.
- The presence of any other neurological sign that in the opinion of the site
investigator raises suspicion for an atypical parkinsonian syndrome (e.g. supranuclear
gaze palsy)
- Treatment for cancer in the last 5 years or cancer patient receiving immunotherapy or
targeted therapy. Individuals with cancers that have not been treated with systemic
chemotherapy, immunotherapy, targeted therapies or radiation therapy are eligible to
enroll in the study.
- Diagnosis of an autoimmune disorder.
- Current treatment with anticoagulants that might preclude safe completion of the
lumbar puncture and that cannot be safely paused in the opinion of the site
investigator.
- Any condition that, in the investigator's opinion, precludes the safe performance of
routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding
diathesis, or clinically significant coagulopathy or thrombocytopenia.
- Diagnosis of dementia
- Pregnant females, if fluoroscopy is needed to obtain the spinal fluid sample
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