MedTrace Logo

Evaluation of Imaging Characteristics of [18F]PI-2620 PET in AD and PSP Patients Using High and Low Specific Activity

NCT04715750 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-05-18

No results posted yet for this study

Summary

This is an open-label study without randomisation. All eligible patients will receive two administrations of the investigational imaging agent \[18F\]PI-2620 at a radioactive dose of 185 MBq, one with high specific activity (≤ 5 µg tracer mass dose), another one with low specific activity (40-50 µg tracer mass dose).

Conditions

Interventions

DRUG

[18F]-PI2620

\[18F\]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 MBq, one with high specific activity (≤ 5 µg tracer mass dose), another one with low specific activity (40-50 µg tracer mass dose).

Sponsors & Collaborators

  • Life Molecular Imaging SA

    collaborator INDUSTRY

  • Life Molecular Imaging GmbH

    lead INDUSTRY

Principal Investigators

  • Andrew Stephens, MD, PhD · Life Molecular Imaging GmbH

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-12
Primary Completion
2022-10-26
Completion
2022-10-26

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04715750 on ClinicalTrials.gov