High-Resolution brain scans aim to unmask Tau's role in Parkinson's
NCT ID NCT07020026
First seen Aug 10, 2026 · Last updated Aug 11, 2026 · Updated 1 time
Summary
This study is testing whether a special PET imaging tracer, [18F]PI-2620, can detect tau protein buildup in the brains of people with Parkinson's disease, including those with a genetic form linked to the LRRK2 gene. About 60 participants will undergo high-resolution brain scans using the NeuroEXPLORER camera. The goal is to compare tau levels between sporadic and LRRK2 Parkinson's cases and see if these scans relate to motor symptoms, cognitive function, and other biomarkers. This could help clarify how tau contributes to Parkinson's and potentially guide future diagnostic or treatment approaches.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- [18F]PI-2620, a radioactive tracer used in PET imaging to detect tau protein in the brain
- What this could lead to
- If successful, this could improve understanding of how tau protein contributes to Parkinson's disease and help identify subtypes or biomarkers for better diagnosis and treatment targeting.
- What could go wrong
- This is an early-stage imaging study with a small number of participants, so findings may not apply to all Parkinson's patients. The tracer's accuracy in detecting tau in Parkinson's is still being validated.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2025
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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45 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Institute for Neurodegenerative Disorders / XingImaging, LLC
RECRUITINGNew Haven, Connecticut, 06510, United States
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