Evaluation of Tau-Pathology in Sporadic and LRRK2 Parkinson's Disease
Evaluation of Tau-Pathology in Sporadic and LRRK2 Parkinson's Disease Using [18F]PI-2620: A High-resolution PET Imaging Study Using NeuroEXPLORER (NX PI-2160 in PD)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 45 Years to 85 Years
- Sex
- All sexes
- Healthy volunteers
- Accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study uses a tracer called [18F]PI-2620 and a detailed PET brain scan to measure buildup of a protein called tau. It includes people with Parkinson’s disease, including the LRRK2 type, people with two other movement disorders, and healthy volunteers.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be 45 to 85 years old, able to follow study steps and attend follow-up visits, and give written consent yourself or through a legal guardian.
- Women must be unable to become pregnant or use study-approved birth control from 14 days before until at least 24 hours after a tracer injection. Some birth control methods must be started earlier.
- Women who can become pregnant must not be pregnant, breastfeeding, or planning pregnancy during the study. Required pregnancy tests must be negative.
- Healthy volunteers must already be in the PPMI study as healthy participants.
- People with Parkinson’s must be in PPMI with sporadic Parkinson’s or LRRK2 Parkinson’s. Results must be known for a spinal fluid test for alpha-synuclein protein and a blood test for phosphorylated tau217 protein.
- People with progressive supranuclear palsy (PSP), a movement disorder, must meet the study’s diagnosis rules. Symptoms must have started 2 to 5 years before screening, with worsening movement problems, trouble looking up or down, balance problems, and an abnormal DaTscan brain scan.
- People with corticobasal syndrome (CBS), a movement and thinking disorder, must meet the study’s diagnosis rules. They must have uneven symptoms on the two sides of the body, problems controlling limb movements or Parkinson-like symptoms, thinking decline, and an abnormal DaTscan brain scan.
Who can't join
- A medical or mental health condition, or an unusual lab result, that the study doctor believes makes participation unsuitable.
- If a screening DaTscan is needed: taking a medicine that affects the scan and being unable or unwilling to stop it for the required time before the scan.
- Use of dopamine-blocking drugs, metoclopramide, or reserpine in the past 6 months before screening for people outside PPMI, or before the baseline visit for PPMI participants.
- A brain MRI showing signs of a serious brain or nerve disorder other than the conditions being studied, as judged by the study doctor.
- Any other reason, including lab results, that the study doctor believes makes the tracer injection unsafe or study enrollment unsuitable.
Simplified for readability. The official criteria below are what the study team uses.
Official 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 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.
Study sites (1)
CT
- Institute for Neurodegenerative Disorders / XingImaging, LLC · New Haven, CT 06510Ashley Romano, Clinical Research Nurse II, RN · Study contact · 475-318-8232 · info_XI001@xingimaging.comLydia Currie, Clinical Research Manager · Study contact · 475-318-8250 · info_XI001@xingimaging.comNeha Prakash, MBBS · Principal investigatorMore trials in New Haven