Parkinson's DiseasePhase 2NCT07020026
Evaluation of Tau-Pathology in Sporadic and LRRK2 Parkinson's Disease
A Phase 2 study testing [18F]PI-2620 in people with Parkinson's Disease, run by Michael J. Fox Foundation for Parkinson's Research at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- [18F]PI-2620
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 12 May 2025to Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- General inclusion criteria 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 control 14 days prior to until at least 24 hours after injection of [18F]PI-2620 or DaTscan.
- 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).
- 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.
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- Females of childbearing potential must not be pregnant, breastfeeding or lactating, or planning pregnancy during the duration of the study.
- 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.
- Non PPMI participant females of childbearing potential must have a negative urine pregnancy test prior to Screening Visit DaTscan injection.
- Healthy Controls:
- Enrolled in the PPMI study as a healthy subject.
- Disease specific inclusion criteria:
- Parkinson's disease
- 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):
- 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).
- 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).
Who cannot join
- 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 derivatives or modafinil, bupropion, phentermine, phencyclidine, fentanyl, or medication commonly considered to interfere with Ioflupane binding per standard clinical practice.
- 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.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Institute for Neurodegenerative Disorders / XingImaging, LLC
New Haven, Connecticut, 06510
Ashley Romano, Clinical Research Nurse II, RN, 475-318-8232, info_XI001@xingimaging.com
Lydia Currie, Clinical Research Manager, 475-318-8250, info_XI001@xingimaging.com
About this study
Official title: 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)
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.
Read the detailed description
The purpose of this study to compare how well [18F] PI-2620, a PET radiotracer targeting Tau protein, bind to brain regions in people with Parkinson's disease (PD), Progressive Supranuclear Palsy, Corticobasal Syndrome, and healthy volunteers.
The study is planned to be conducted over a period of two years. The study aims to assess the tau burden in PD compared to diseased and healthy controls with PET imaging using [18F]PI-2620 and utilizing the new NX PET camera. The study will include subjects already enrolled in the PPMI study to enable efficient enrollment. The study will utilize clinical and imaging assessments obtained during the PPMI study visit to reduce the subject burden and enable longitudinal PPMI study data used in the study analysis.
In the first year, half of the cohort will be recruited including 10 sporadic PD, 10 LRKK2 PD, 5 PSP/CBS, and 5 Healthy controls. The first-year cohorts, may be scanned on both the NX and the conventional PET camera to allow for comparison of tau deposits visualization between the two camera systems.
During the second year, remaining cohorts will be recruited to acquire the [18F]PI-2620 image using the NX PET camera. In order to investigate the temporal change in tau pathology in PD, participants recruited in the first year will be followed up at 12 months with repeat imaging with NX.
- Conditions
- Parkinson's Disease
- Being tested
- [18F]PI-2620
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]PI-2620Drug
All participants will undergo PET imaging using the [18F]PI-2620 tau-binding tracer.
| Study group | Role | What they receive |
|---|---|---|
| Parkinson's Disease (PD) | Experimental | Sporadic and LRRK2 Receives: Drug: [18F]PI-2620 |
| Tauopathy | Experimental | Progressive Supranuclear Palsy (PSP) and Corticobasal Syndrome (CBS) Receives: Drug: [18F]PI-2620 |
| Healthy | Experimental | Healthy participants Receives: Drug: [18F]PI-2620 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of tau binding between study cohort using Standardized Uptake Value ratio ( SUVr)
Determination of [18F]PI-2620 binding in brain regions in all participants with NX acquired images to compare tau binding between study cohorts.
Measured: Once during single PET imaging
Secondary outcomes (4)
Comparison of Tau imaging to clinical profile
To compare [18F]PI-2620 binding with clinical assessments including motor and cognitive rating scale.
Measured: Once during single PET imaging
Comparison of Tau imaging to biomarker profile
To compare [18F]PI-2620 binding with CSF Synuclein Seed Amplification status. To compare [18F]PI-2620 binding with plasma phosphoTau217.
Measured: Once during single PET imaging
Compare Tau binding between Standard and high-resolution PET camera in all participants using SUVr.
To compare the tau binding in all participants between the NX and conventional PET scanner (Siemens Biograph mCT).
Measured: Once during single PET imaging
Compare longitudinal change
To compare longitudinal change in [18F]PI-2620 binding over a period of 12 months across all cohorts.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start12 May 2025
- Primary completionApr 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michael J. Fox Foundation for Parkinson's Research
- Sponsor type
- University, hospital or other
- Collaborators
- Institute for Neurodegenerative Disorders
- Responsible party
- Sponsor
- Investigators
- Ken Marek, MD, Study chair, Institute for Neurodegenerative Disorders
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07020026
- Sponsor's protocol ID
- XI-001 (PPMI 029)
- Status last verified
- Aug 2026
- First submitted
- 23 May 2025
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07020026
- Acronym / sponsor ID
- XI-001 (PPMI 029)
- Conditions
- Parkinson's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Michael J. Fox Foundation for Parkinson's ResearchUniversity, hospital or other
- Collaborators
- Institute for Neurodegenerative Disorders
- Study start
- 12 May 2025 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 13 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The purpose of this study to compare how well [18F] PI-2620, a PET radiotracer targeting Tau protein, bind to brain regions in people with Parkinson's disease (PD), Progressive Supranuclear Palsy, Corticobasal Syndrome, and healthy volunteers.
The study is planned to be conducted over a period of two years. The study aims to assess the tau burden in PD compared to diseased and healthy controls with PET imaging using [18F]PI-2620 and utilizing the new NX PET camera. The study will include subjects already enrolled in the PPMI study to enable efficient enrollment. The study will utilize clinical and imaging assessments obtained during the PPMI study visit to reduce the subject burden and enable longitudinal PPMI study data used in the study analysis.
In the first year, half of the cohort will be recruited including 10 sporadic PD, 10 LRKK2 PD, 5 PSP/CBS, and 5 Healthy controls. The first-year cohorts, may be scanned on both the NX and the conventional PET camera to allow for comparison of tau deposits visualization between the two camera systems.
During the second year, remaining cohorts will be recruited to acquire the [18F]PI-2620 image using the NX PET camera. In order to investigate the temporal change in tau pathology in PD, participants recruited in the first year will be followed up at 12 months with repeat imaging with NX.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Parkinson's Disease (PD) | Experimental | Drug: [18F]PI-2620Sporadic and LRRK2 |
| Tauopathy | Experimental | Drug: [18F]PI-2620Progressive Supranuclear Palsy (PSP) and Corticobasal Syndrome (CBS) |
| Healthy | Experimental | Drug: [18F]PI-2620Healthy participants |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- 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 control 14 days prior to until at least 24 hours after injection of [18F]PI-2620 or DaTscan.
- 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).
- 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.
Key exclusion criteria (6 listed)
- 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 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [18F]PI-2620All participants will undergo PET imaging using the [18F]PI-2620 tau-binding tracer. | Drug | Healthy, Parkinson's Disease (PD), Tauopathy |
Primary outcome
Comparison of tau binding between study cohort using Standardized Uptake Value ratio ( SUVr)
Time frame: Once during single PET imaging
Determination of [18F]PI-2620 binding in brain regions in all participants with NX acquired images to compare tau binding between study cohorts.
4 secondary outcomes
Comparison of Tau imaging to clinical profile
Time frame: Once during single PET imaging
Comparison of Tau imaging to biomarker profile
Time frame: Once during single PET imaging
Compare Tau binding between Standard and high-resolution PET camera in all participants using SUVr.
Time frame: Once during single PET imaging
Compare longitudinal change
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ken Marek, MD study chair
Institute for Neurodegenerative Disorders
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing [18F]PI-2620 in people with Parkinson's Disease, run by Michael J. Fox Foundation for Parkinson's Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ashley Romano, RN (475-318-8232, info_XI001@xingimaging.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of tau binding between study cohort using Standardized Uptake Value ratio ( SUVr) (time frame: Once during single PET imaging). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.