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Test-retest Study With [18F]PI-2620 in PSP-RS and NDC | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

An Open Label, Single Center Study to Evaluate the Safety and Test-retest Characteristics of [18F]PI-2620 as PET Radioligand for Imaging Tau Deposition in the Brains of Patients With Progressive Supranuclear Palsy Richardson Syndrome (PSP-RS) Compared to Non-demented Controls (NDC)

NCT05187546•Life Molecular Imaging GmbH

View on ClinicalTrials.gov

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)

Detailed Description

The imaging characteristics of \[18F\]PI-2620 using positron emission tomography (PET) in patients with progressive supranuclear palsy, Richardson's syndrome (PSP-RS) will be evaluated by a) determining the test-retest variability of the \[18F\]PI-2620 binding parameters in brain of patients with PSP-RS and non-demented controls (NDC).

Eligibility

Age

50 - 80 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•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
+6 more criteria

Exclusion Criteria

•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
+2 more criteria

Locations (1)

Ludwig-Maximilians-Universität München

Munich, Germany

Key Dates

Start Date

March 10, 2022

Primary Completion Date

February 29, 2024

Completion Date

March 5, 2024

Last Updated

May 18, 2025

Enrollment

ACTUAL participants

Conditions

Progressive Supranuclear Palsy

Interventions

[18F]-PI2620

DRUG

UPenn Observational Research Repository on Neurodegenerative Disease

NCT04715399

Frontotemporal Degeneration(FTD)Primary Progressive Aphasia(PPA)+7 more

View study

RECRUITINGNA

The Swedish BioFINDER 2 Study

NCT03174938

DementiaAlzheimer Disease+10 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 18, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

UPenn Observational Research Repository on Neurodegenerative Disease

The Swedish BioFINDER 2 Study

The Use of the CUE1/CUE1+ in People With Parkinson's Disease and Related Disorders

Quality of Life of the Patient and the Burden of the Caregiver in Progressive Supranuclear Palsy

Modifiable Variables in Parkinsonism (MVP)

Parkinson Atypical Rating of Oculometric Patterns Evaluated Routinely