Test-retest Study With [18F]PI-2620 in PSP-RS and NDC

NCT05187546 | Completed Phase 1

• 1 other identifier: LMT-02-01-21
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The overall goal of this protocol is to evaluate the imaging characteristics of \[18F\]PI-2620 using positron emission tomography (PET) in patients with progressive supranuclear palsy, Richardson's syndrome (PSP-RS)

Conditions

Progressive Supranuclear Palsy

Keywords

Tau PET; [18F]PI-2620; Test-retest; Progressive Supranuclear Palsy

Outcome Measures

Primary Outcomes (2)

• Test-retest variability of the [18F]PI-2620 binding parameters in brain of patients with PSP-RS and non-demented controls

  Test-retest variability of \[18F\]PI-2620 accumulation will be analyzed using quantification

  The duration of the study for participants may be up to 74 days

• Number of adverse events

  Safety will be evaluated by collection of Adverse Events.

  The duration of the study for participants may be up to 74 days

Secondary Outcomes (2)

• Compare quantification in terms if test-retest variability in PSP-RS and NDC

  The duration of the study for participants may be up to 74 days

• Correlate radioligand binding in PSP-RS with clinical scales

  The duration of the study for participants may be up to 74 days

Study Arms (2)

Imaging characteristics of [18F]PI-2620 for detection of Tau deposition in the brain of PSP patients

EXPERIMENTAL

All eligible PSP patients will receive two injections of the investigational imaging agent \[18F\]PI-2620: at a baseline PET imaging session and at a follow-up PET imaging session to evaluate the test-retest imaging characteristics. 10 PSP patients will be required to complete the study arm.

Drug: [18F]-PI2620

Imaging characteristics of [18F]PI-2620 for detection of Tau deposition in the brain of NDC subjects

EXPERIMENTAL

All eligible non-demented control (NDC) subjects will receive two injections of the investigational imaging agent \[18F\]PI-2620: at a baseline PET imaging session and at a follow-up PET imaging session to evaluate the test-retest imaging characteristics. 5 NDC subjects will be required to complete the study arm.

Drug: [18F]-PI2620

Interventions

[18F]-PI2620 DRUG

\[18F\]PI-2620 is a radioactive diagnostic agent being developed for the indication of PET imaging of the brain to detect tau pathology in adult patients who are being evaluated for neurodegenerative decline. All patients will receive two administrations of \[18F\]PI-2620 at a radioactive dose of 185 megabecquerel (MBq).

Imaging characteristics of [18F]PI-2620 for detection of Tau deposition in the brain of NDC subjects; Imaging characteristics of [18F]PI-2620 for detection of Tau deposition in the brain of PSP patients

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females aged 50-80 years
• Able to understand, sign and date written informed consent
• Signed and dated written informed consent obtained from the subject
• The subject has an appropriate caregiver capable of accompanying subject, if necessary
• Have an Montreal Cognitive Assessment (MoCa) score ≥ 27
• Female subjects must be documented by medical records or physician's note to be either surgically sterile (by means of hysterectomy, bilateral salpingectomy or bilateral oophorectomy) or post-menopausal for at least 1 year (no menses for 12 months without an alternative medical cause). If they are of child-bearing potential, must commit to use of a highly effective contraceptive measure for the duration of the study
• Male subjects and their partners of childbearing potential must commit to the use of a highly effective method of contraception for a minimum of 90 days following each PET scan
• Male subjects must commit to not donate sperm for a minimum of 90 days after each PET scan
• Willing and able to cooperate with study procedures including lying flat and still on the scanning bed for 60 minutes
• Healthy with no clinically relevant finding on physical examination at screening
• No cognitive impairment from neuropsychological battery as judged by the investigator
• A brain MRI without evidence of significant neurological pathology
• A beta-amyloid Neuraceq® PET demonstrating a negative beta-amyloid status
• No signs of movement disorder as judged by Progressive Supranuclear Palsy Rating Scale (PSPRS), Movement Disorder Society - Unified Parkinson's Disability Rating Scale (MDS-UPDRS) and Progressive Supranuclear Palsy Clinical Deficits Scale (PSP-CDS)
• Patients with a clinical diagnosis of probable PSP-RS based on the Movement Disorder Society criteria (Höglinger et al., 2017)

You may not qualify if:

• Hemoglobin value \< 10 g/dL
• Laboratory tests with clinically significant abnormalities and/or clinically significant unstable medical illness equivalent to CTC v5.0 (common toxicity criteria) toxicities greater than grade 2
• Evidence of clinically significant disease that is expected to interfere with cognitive assessments or the ability to complete the study procedures
• Subjects with clinically significant renal and hepatic dysfunction as judged by the investigator
• Known hypersensitivity to the active substance or to any of the excipients of \[18F\]PI-2620
• Known hypersensitivity to the active substance or to any of the excipients of Neuraceq®, for NDC only
• Subject has received an investigational drug including treatments targeting Amyloid-beta or tau within 3 months of screening
• Pregnant (or having the intention of getting pregnant), lactating or breastfeeding
• Unsuitable veins for repeated venipuncture.
• Subject has a contraindication to blood sampling and/or arterial cannulation, including but not limited to peripheral vascular disease, Raynaud's phenomenon as determined by abnormal Allen's test or abnormal coagulation profile at screening
• Implants such as implanted cardiac pacemakers or defibrillators, insulin pumps, cochlear implants, metallic ocular foreign body, implanted neural stimulators, CNS aneurysm clips and other medical implants that have not been certified for MRI, or history of claustrophobia in MRI
• Unwilling and/or unable to cooperate with study procedures

Sponsors & Collaborators

• Life Molecular Imaging GmbH: lead

Study Sites (1)

Ludwig-Maximilians-Universität München

Munich, 81377, Germany

Location

MeSH Terms

Conditions

Supranuclear Palsy, Progressive

Interventions

((18)F)PI-2620

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Ophthalmoplegia; Ocular Motility Disorders; Cranial Nerve Diseases; Tauopathies; Neurodegenerative Diseases; Paralysis; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Andrew Stephens, MD, PhD

  Life Molecular Imaging

  STUDY DIRECTOR

• Matthias Brendel, MD

  Department of Nuclear Medicine, University of Munich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2021
• First Posted: January 12, 2022
• Study Start: March 10, 2022
• Primary Completion: February 29, 2024
• Study Completion: March 5, 2024
• Last Updated: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)