Recruiting
Phase 2

\[18F\]PI-2620

Sponsor:

Michael J. Fox Foundation for Parkinson's Research

Code:

NCT07020026

Conditions

Parkinson's Disease

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Accepted

Interventions

[18F]PI-2620

Study Details

Brief 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.

Conditions

Parkinson's Disease

Study ID

NCT07020026

Start date

May 12, 2025

Status verified date

Aug, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

60 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Parkinson's Disease (PD)

Sporadic and LRRK2

experimental: Tauopathy

Progressive Supranuclear Palsy (PSP) and Corticobasal Syndrome (CBS)

experimental: Healthy

Healthy participants

Interventions

[18F]PI-2620

All participants will undergo PET imaging using the \[18F\]PI-2620 tau-binding tracer.

Primary outcome measure

  • Comparison of tau binding between study cohort using Standardized Uptake Value ratio ( SUVr) [ Time Frame: Once during single PET imaging ]

Central Contacts and Locations

Central contacts

Locations

Institute for Neurodegenerative Disorders / XingImaging, LLC

Recruiting

New Haven, Connecticut, United States, 06510

Contacts

Ashley Romano, Clinical Research Nurse II, RN

475-318-8232info_XI001@xingimaging.com

Lydia Currie, Clinical Research Manager

475-318-8250info_XI001@xingimaging.com

Principal Investigator:

Neha Prakash, MBBS

More Information

Sponsor

Michael J. Fox Foundation for Parkinson's Research

Last update posted

Aug 10, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Michael J. Fox Foundation for Parkinson's Research on 2026-08-10.