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New treatment option for Parkinson's Disease
Official title Evaluation of Tau-Pathology in Sporadic and LRRK2 Parkinson's Disease
ClinicalTrials.gov ID: NCT07020026
What this study is testing
What is [18F]PI-2620?
[18F]PI-2620 is an investigational medicine, being studied as a potential treatment for parkinson's disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to evaluate the burden of tau pathology in people with Sporadic and LRRK2 PD via in vivo imaging using the tau tracer, [18F]PI-2620, and a high resolution PET camera, NeuroEXPLORER.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 to 85. Healthy volunteers may be eligible.
You may be able to join if
- General include the following:
- Ability to comply with the study procedures and attend follow-up visits.
- Written informed consent from the participant or legal guardian.
- Male or Female between 45 years and 85 years of age (Females must meet additional criteria specified below, as applicable) a. Females must be of...
- Diagnosis of progressive supranuclear palsy (PSP) based on the Clinical diagnosis of progressive supranuclear palsy: The movement disorder society...
You likely can't join if
- Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation.
- For those receiving Screening DaTscan:
- Received any of the following medications that could interfere with the imaging and unwilling or medically unable to hold them for five half-lives...
- Received any of the following drugs: dopamine receptor blockers (neuroleptics), metoclopramide and reserpine, within 6 months of Screening Visit for...
- Any structural abnormality or finding on previously obtained or screening brain MRI suggestive of clinically significant neurological disorders other...
- Any other reason that in the opinion of the investigator, including abnormal labs, that could interfere with the safety with radiotracer injection...
See the full eligibility criteria
- General include the following:
- Ability to comply with the study procedures and attend follow-up visits.
- Written informed consent from the participant or legal guardian.
- Male or Female between 45 years and 85 years of age (Females must meet additional criteria specified below, as applicable) a. Females must be of non-childbearing potential or using a highly effective method of birth...
- Diagnosis of progressive supranuclear palsy (PSP) based on the Clinical diagnosis of progressive supranuclear palsy: The movement disorder society criteria (Höglinger et al., 2017).
- Symptom onset within 2-5 years prior to screening.
- Progressive motor symptoms including vertical supranuclear gaze palsy, postural instability, and other signs of parkinsonism.
- Evidence of striatal degeneration in form of abnormal DaTscan (previously obtained DaTscan since onset of motor symptoms may be used). c) Corticobasal Syndrome (CBS):
- Diagnosis of corticobasal syndrome (CBS) based on clinical criteria, with asymmetric motor and cognitive dysfunction (Armstrong et al., 2013).
- Presence of limb apraxia, dystonia, alien limb phenomenon, and/or parkinsonism (e.g., rigidity, bradykinesia).
- Cognitive decline as indicated by impairment in attention, executive function, or memory.
- Evidence of striatal degeneration in form of abnormal DaTscan (previously obtained DaTscan since onset of motor symptoms may be used).
- Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation.
- For those receiving Screening DaTscan:
- Received any of the following medications that could interfere with the imaging and unwilling or medically unable to hold them for five half-lives before SPECT imaging: alpha methyldopa, methylphenidate, amphetamine...
- Received any of the following drugs: dopamine receptor blockers (neuroleptics), metoclopramide and reserpine, within 6 months of Screening Visit for non-PPMI participants or within 6 months of Baseline Visit for PPMI...
- Any structural abnormality or finding on previously obtained or screening brain MRI suggestive of clinically significant neurological disorders other than the diseases of interest (in the opinion of the investigator).
- Any other reason that in the opinion of the investigator, including abnormal labs, that could interfere with the safety with radiotracer injection, would render the participant unsuitable for the study enrollment.
The study team makes the final eligibility decision.
Where it's taking place
- New Haven, Connecticut, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 45 years to 85 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Haven, Connecticut, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.