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89Zr-DFO-AP-101 Imaging for ALS

Phase 1

Recruiting

Led By Brigitte Guérin, PhD

Research Sponsored by Université de Sherbrooke

Eligibility Criteria Checklist

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

Must have

For healthy participants: no neurologic condition (confirmed by physical exam)

For healthy participants: Male or female subjects aged 50 years or older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre-dose and at 2 hours, 1, 3, 7, 10 days post-dose

Awards & highlights

Study Summary

This trial studies a new imaging test to detect and monitor ALS progression, which may lead to earlier diagnosis and better treatment for those affected. #ALS #LouGehrigsDisease #PETImaging

Who is the study for?

This trial is for healthy adults over 50 and ALS patients aged 18 or older who can lie down for up to 45 minutes without help. Participants must not have other neurodegenerative diseases, severe psychiatric illnesses, recent blood transfusions, or be on certain respiratory support. Pregnant women and those not using contraception are excluded.Check my eligibility

What is being tested?

The study tests a new PET scan radiotracer called [89Zr]Zr-DFO-AP-101 in both healthy volunteers and ALS patients to evaluate its safety and how it spreads throughout the body. This could potentially help in early detection of ALS.See study design

What are the potential side effects?

As this is a phase I trial primarily assessing safety, potential side effects may include reactions at the injection site, allergic responses to the tracer substance, or changes in blood pressure but specific side effects will be monitored closely.

Eligibility Criteria

Inclusion Criteria

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

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I do not have any neurological conditions.

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I am 50 years old or older.

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I can lie down for 45 minutes without needing help to breathe.

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My ALS diagnosis is confirmed by El-Escorial criteria.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-dose and at 2 hours, 1, 3, 7, 10 days post-dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-dose and at 2 hours, 1, 3, 7, 10 days post-dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose and at 2 hours, 1, 3, 7, 10 days post-dose for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Biodistribution of [89Zr]Zr-DFO-AP-101

Dosimetry of [89Zr]Zr-DFO-AP-101 in human

Incidence of adverse events (AEs) and serious adverse events (SAEs)

Secondary outcome measures

Area under the curve (AUC)

Cmax

Excretion

+1 more

Other outcome measures

Differential labeling and uptake

Trial Design

2Treatment groups

Experimental Treatment

Group I: Patients with ALSExperimental Treatment1 Intervention

Will receive 40MBq of 89Zr-DFO-AP-101, once, at Day 0.

Group II: Healthy participantsExperimental Treatment1 Intervention

Will receive 40MBq of 89Zr-DFO-AP-101, once, at Day 0.

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?

Université de SherbrookeLead Sponsor

293 Previous Clinical Trials

69,503 Total Patients Enrolled

Chorus Wellness Inc.Industry Sponsor

1 Previous Clinical Trials

144 Total Patients Enrolled

AL-S Pharma AGUNKNOWN

Frequently Asked Questions

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

Are new participants required for the experiment at this juncture?

"As per the information posted on clinicaltrials.gov, this medical trial is still actively recruiting participants. The research was initially made public on November 23rd 2023 and has been revised since then."

Answered by AI

How many patients are currently being treated in this clinical trial?

"Affirmative. Clinicaltrials.gov documents illustrate that this investigation is actively enrolling participants, with the original posting date being November 23rd 2023 and the most recent edit occurring on the same day. 12 volunteers are needed from one research centre to complete this trial."

Answered by AI

Has the Food & Drug Administration approved any treatments for those living with ALS?

"The safety of participants with ALS in this Phase 1 trial has been rated a 1 due to the limited efficacy and safety data available."

Answered by AI

What are the expectations of this experiment?

"The primary objective of this trial, which is taking place over a 14-day time frame starting post-injection, will be to measure the Biodistribution of [89Zr]Zr-DFO-AP-101. During this experiment, secondary objectives include assessing Cmax (Maximal concentration of [89Zr]Zr-DFO-AP-101 in plasma), AUC (Area under the curve of [89Zr]Zr-DFO AP 101 in plasma) and residence time (Time taken for half the amount of [89Zr ZR DFO AP 101 in plasma)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety and Dosimetry of a New Radiotracer to Detect Misfolded SOD1 Associated With Amyotrophic Lateral Sclerosis

2023. "Safety and Dosimetry of a New Radiotracer to Detect Misfolded SOD1 Associated With Amyotrophic Lateral Sclerosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05974579.

All > Lou Gehrigs Disease > Als