No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
45 – 85
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Diagnostic
Participants needed
60 (estimated)
Sponsor
Michael J. Fox Foundation for Parkinson's Research · Other
Who this trial is looking for
This trial is looking for people with Parkinson's disease to study tau pathology using a special imaging technique. Participants will undergo scans at a testing facility and must meet certain health criteria.
Are You a Good Fit for This Trial?
Must not be takingDopamine receptor blockersMethylphenidateAmphetamine derivativesModafinilBupropionPhentermine
You may be able to join if
I am between 45 and 85 years old.
I can provide written consent for myself or have my guardian do so.
I have been diagnosed with Parkinson's disease.
I am enrolled as a participant in the PPMI study.
I am not pregnant or planning to become pregnant.
You may not be able to join if
I have a significant medical or psychiatric condition that could affect my participation.
I have taken certain medications that interfere with imaging in the past few months.
I have had a brain MRI showing serious neurological issues.
I have abnormal lab results that would make me unsafe for this study.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
General inclusion criteria include the following:
1. Ability to comply with the study procedures and attend follow-up visits.
2. Written informed consent from the participant or legal guardian.
3. Male or Female between 45 years and 85 years of age (Females must meet additional…
Inclusion Criteria:
General inclusion criteria include the following:
1. Ability to comply with the study procedures and attend follow-up visits.
2. Written informed consent from the participant or legal guardian.
3. 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 control 14 days prior to until at least 24 hours after injection of \[18F\]PI-2620 or DaTscan.
i. Non-childbearing potential is defined as a female that must be either postmenopausal (no menses for at least 12 months prior to PET scan) or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy).
ii. Highly effective method of birth control is defined as practicing at least one of the following: A birth control method that results in a less than 1% per year failure rate when used consistently and correctly, such as oral contraceptives for at least 3 months prior to injection, an intrauterine device (IUD) for at least 2 months prior to injection, or barrier methods, e.g., diaphragm or combination condom and spermicide. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) is not acceptable.
b. Females of childbearing potential must not be pregnant, breastfeeding or lactating, or planning pregnancy during the duration of the study.
c. Non PPMI participant females of childbearing potential must have a negative serum pregnancy test at Screening and all females of childbearing potential must have negative urine pregnancy test prior to \[18F\]PI-2620 injection on day of Baseline PET scan.
d. Non PPMI participant females of childbearing potential must have a negative urine pregnancy test prior to Screening Visit DaTscan injection.
Healthy Controls:
a) Enrolled in the PPMI study as a healthy subject.
Disease specific inclusion criteria:
a) Parkinson's disease
a. Enrolled in the PPMI study as a sporadic PD or LRRK2 PD participant. b. Known CSF alpha synuclein seeding amplification assay status. c. Known Plasma phosphorylated Tau217 status. b) Progressive Supranuclear Palsy (PSP):
1. Diagnosis of progressive supranuclear palsy (PSP) based on the Clinical diagnosis of progressive supranuclear palsy: The movement disorder society criteria (Höglinger et al., 2017).
2. Symptom onset within 2-5 years prior to screening.
3. Progressive motor symptoms including vertical supranuclear gaze palsy, postural instability, and other signs of parkinsonism.
4. Evidence of striatal degeneration in form of abnormal DaTscan (previously obtained DaTscan since onset of motor symptoms may be used).
c) Corticobasal Syndrome (CBS):
1. Diagnosis of corticobasal syndrome (CBS) based on clinical criteria, with asymmetric motor and cognitive dysfunction (Armstrong et al., 2013).
2. Presence of limb apraxia, dystonia, alien limb phenomenon, and/or parkinsonism (e.g., rigidity, bradykinesia).
3. Cognitive decline as indicated by impairment in attention, executive function, or memory.
4. Evidence of striatal degeneration in form of abnormal DaTscan (previously obtained DaTscan since onset of motor symptoms may be used).
Exclusion Criteria:
1. Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation.
2. 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 derivatives or modafinil, bupropion, phentermine, phencyclidine, fentanyl, or medication commonly considered to interfere with Ioflupane binding per standard clinical practice.
3. 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 participants.
4. 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).
5. 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.
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