12 Participants Needed

89Zr-DFO-AP-101 Imaging for ALS

AT
SC
Overseen BySarah Côté-Bigras, MSc
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

Amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's Disease, is a rare neurodegenerative disease resulting in loss, primarily, of the motor neurons in the motor cortex, brainstem and spinal cord. It currently affects 3 of every 100,000 people in the US.Currently, there is no diagnostic tool for ALS, resulting in misdiagnosis and significant disease progression before formal diagnosis. An imaging test for early detection of ALS and for monitoring disease progression would have significant diagnostic and prognostic value.PET imaging with an appropriate radiotracer has great potential as a biomarker for ALS given that it would permit visualization of central nervous system (CNS) pathology in individuals living with the disease.To that extent, the primary goal of this phase I study is evaluating the safety and biodistribution of the new tracer \[89Zr\]Zr-DFO-AP-101 in healthy volunteers and ALS patients.

Who Is on the Research Team?

BG

Brigitte Guérin, PhD

Principal Investigator

Estrie University Integrated Health and Social Services Center - University Hospital of Sherbrooke

EE

Eric E Turcotte, MD

Principal Investigator

Estrie University Integrated Health and Social Services Center - University Hospital of Sherbrooke

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I do not have any neurological conditions.
Have venous access sufficient to allow for blood sampling
I am committed to following the study's procedures and can participate for its full duration.
See 3 more

Exclusion Criteria

I have had a tracheostomy for my ALS symptoms.
You have a history of allergic reactions to certain medications or antibodies.
I have conditions that cause muscle weakness.
See 17 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks
1 visit (in-person)

Treatment

Participants receive a single intravenous dose of [89Zr]Zr-DFO-AP-101 and undergo PET/CT imaging

10 days
5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • 89Zr-DFO-AP-101
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Patients with ALSExperimental Treatment1 Intervention
Group II: Healthy participantsExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Université de Sherbrooke

Lead Sponsor

Trials
317
Recruited
79,300+

Chorus Wellness Inc.

Industry Sponsor

Trials
2
Recruited
160+

AL-S Pharma AG

Collaborator

Trials
1
Recruited
10+

Eli Lilly and Company

Industry Sponsor

Trials
2,708
Recruited
3,720,000+
Dr. Daniel Skovronsky profile image

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks profile image

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

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