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[18F]APN-1607 PET Scan for Progressive Supranuclear Palsy

Phase 1

Recruiting

Led By David Russell, M.D., Ph.D.

Research Sponsored by Invicro

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants receiving arterial cannulation must have adequate circulation to the hand for safe placement of arterial line and normal blood clotting

Body weight range of ≥ 43 kg to ≤ 120 kg

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 72 weeks

Awards & highlights

Study Summary

This trial is testing a new PET scan to measure tau pathology in people with Progressive Supranuclear Palsy.

Who is the study for?

This trial is for men and women aged 50-80 with Progressive Supranuclear Palsy or healthy, weighing 43-120 kg, and scoring ≥20 on the MMSE. Women must use contraception. Exclusions include recent investigational drug/device use, excessive radiation exposure, certain medication/supplement use, major surgery/blood loss recently, HIV/immunodeficiency diseases history, cancer within 5 years (except some skin cancers), unsuitable veins or heart rate issues.Check my eligibility

What is being tested?

[18F]APN-1607 is being tested as a PET radiotracer to track tau protein changes in the brain over time in people with PSP. The study involves comparing scans from participants with PSP against those from healthy subjects to see if [18F]APN-1607 can effectively measure tau pathology progression.See study design

What are the potential side effects?

Potential side effects of [18F]APN-1607 are not detailed here but may include reactions related to PET scanning such as discomfort at injection site or allergic reaction to the tracer. As it's an imaging agent rather than a therapeutic drug, fewer side effects are expected compared to typical medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My hand's blood flow and clotting are normal for a safe arterial line placement.

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My weight is between 43 kg and 120 kg.

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My mental function score is 20 or higher.

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I am between 50 and 80 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 72 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~72 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 72 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in standardized uptake value ratios (SUVRs) of regional [18F]APN-1607.

Trial Design

1Treatment groups

Experimental Treatment

Group I: [18F]APN-1607Experimental Treatment1 Intervention

Participants will receive an IV bolus injection of [18F]APN-1607, followed by PET brain imaging.

0 / 4Eligibility criteria met

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

InvicroLead Sponsor

16 Previous Clinical Trials

367 Total Patients Enrolled

David Russell, M.D., Ph.D.Principal InvestigatorInvicro

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the eligibility criteria for participating in this experimental protocol?

"This medical trial seeks 18 individuals between the ages of 50 and 80 with a diagnosis of progressive supranuclear palsy (PSP)."

Answered by AI

How could [18F] APN-1607 potentially impact human health?

"As this is only a Phase 1 trial, there are limited safety and efficacy data available. Therefore, our team at Power has assigned [18F] APN-1607 a score of 1 on the risk scale."

Answered by AI

How many individuals are being included in this experiment?

"Affirmative. Clinicaltrials.gov data provides evidence that this experiment is actively seeking participants; the trial was initially posted on May 25th 2021 and revised most recently on July 1st 2022, with 18 patients required across a single medical facility."

Answered by AI

Does this clinical trial have an age limit, and if so, what is it?

"Participants to this trial must be between 50 and 80 years old. Separately, there are separate trials for those under 18 (50) and over 65 (390)."

Answered by AI

Is there room to enroll participants in this experiment?

"Affirmative, clinicaltrials.gov displays that this research is still searching for participants since its initiation on May 25th 2021 and the latest update on July 1st 2022. The trial requires 18 test subjects found at one site specifically."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evaluation of [18F]APN-1607 as a PET Biomarker

2021. "Evaluation of [18F]APN-1607 as a PET Biomarker". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05005819.

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