---
title: Brain imaging maps protein clumps
nct_id: NCT07020026
phase: PHASE2
status: RECRUITING
sponsor: "Michael J. Fox Foundation for Parkinson's Research"
study_type: INTERVENTIONAL
canonical_url: "https://parkinsonspathways.com/trial/NCT07020026"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07020026"
last_fetched: "2026-05-10T14:04:11.316Z"
source: "Parkinson's Pathways (curated)"
---
# Brain imaging maps protein clumps

**Goal (in five words):** Brain imaging maps protein clumps

**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)

**Trial ID:** [NCT07020026](https://clinicaltrials.gov/study/NCT07020026)

## Key Facts

- **Phase:** PHASE2
- **Status:** RECRUITING
- **Study Type:** INTERVENTIONAL
- **Sponsor:** Michael J. Fox Foundation for Parkinson's Research
- **Target Enrollment:** 60 participants
- **Start Date:** 2025-05-12
- **Completion Date:** 2027-04
- **Conditions:** Parkinson's Disease
- **Interventions:** [18F]PI-2620
- **Intervention Types:** DRUG

## Summary For Families

The goal is to map where tau protein builds up in people with sporadic and LRRK2 Parkinson's disease, and compare that to controls and other parkinsonian syndromes to see how tau relates to symptoms and blood or CSF biomarkers. The approach uses a high-resolution NeuroEXPLORER PET scan with [18F]PI-2620, a radioactive tracer that binds aggregated tau so affected brain regions light up on imaging; it is a diagnostic scan, not a treatment, so it does not change levodopa or other Parkinson's medications. The trial is enrolling adults 45 to 85 years old, mainly participants already in the PPMI study as sporadic or LRRK2 PD, plus PPMI healthy controls and people with PSP or CBS who meet clinical and DaTscan criteria. Participants must be able to consent, have known CSF alpha-synuclein seeding and plasma pTau217 status if in the PD groups, and women of childbearing potential must have negative pregnancy tests and use effective contraception.

## Eligibility

- **Minimum age:** 45 Years
- **Maximum age:** 85 Years
- **Sex:** ALL

### Full 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.
```

## Locations (1)

- Institute for Neurodegenerative Disorders / XingImaging, LLC, New Haven, Connecticut, United States _(41.3081, -72.9282)_
  - Ashley Romano, Clinical Research Nurse II, RN — (CONTACT) — 475-318-8232 — info_XI001@xingimaging.com
  - Lydia Currie, Clinical Research Manager — (CONTACT) — 475-318-8250 — info_XI001@xingimaging.com
  - Neha Prakash, MBBS — (PRINCIPAL_INVESTIGATOR)

## Central Contacts

- Ashley Romano, RN — (CONTACT) — 475-318-8232 — info_XI001@xingimaging.com

---

*Canonical: https://parkinsonspathways.com/trial/NCT07020026*  
*HTML version: https://parkinsonspathways.com/trial/NCT07020026*  
*Source data: https://clinicaltrials.gov/study/NCT07020026*