Evaluation of Tau-Pathology in Sporadic and LRRK2 Parkinson's Disease

NCT07020026 | Recruiting Phase 2 FDA Drug

• 1 other identifier: XI-001 (PPMI 029)
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Once during single PET imaging

Secondary Outcomes (4)

• Comparison of Tau imaging to clinical profile

  Once during single PET imaging

• Comparison of Tau imaging to biomarker profile

  Once during single PET imaging

• Compare Tau binding between Standard and high-resolution PET camera in all participants using SUVr.

  Once during single PET imaging

• Compare longitudinal change

  12 months

Study Arms (3)

Parkinson's Disease (PD)

EXPERIMENTAL

Sporadic and LRRK2

Drug: [18F]PI-2620

Tauopathy

EXPERIMENTAL

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

Drug: [18F]PI-2620

Healthy

EXPERIMENTAL

Healthy participants

Drug: [18F]PI-2620

Interventions

[18F]PI-2620 DRUG

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

Healthy; Parkinson's Disease (PD); Tauopathy

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• 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):
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Michael J. Fox Foundation for Parkinson's Research: lead
• Institute for Neurodegenerative Disorders: collaborator

Study Sites (1)

Institute for Neurodegenerative Disorders / XingImaging, LLC

New Haven, Connecticut, 06510, United States

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Interventions

((18)F)PI-2620

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Ken Marek, MD

  Institute for Neurodegenerative Disorders

  STUDY CHAIR

Central Study Contacts

Ashley Romano, RN

CONTACT

475-318-8232; info_XI001@xingimaging.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2025
• First Posted: June 13, 2025
• Study Start: May 12, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: June 13, 2025

Record last verified: 2025-06

Locations

US (1)