89Zr-DFO-AP-101 Imaging for ALS

Overseen By Sarah Côté-Bigras, MSc

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Université de Sherbrooke

Must not be taking: Biologics, Monoclonal antibodies

Disqualifiers: Pregnancy, Surgery, Psychiatric illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 10 days

12 Participants Needed

Trial Summary

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.

Research Team

Brigitte Guérin, PhD

Principal Investigator

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

Eric E Turcotte, MD

Principal Investigator

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

Eligibility Criteria

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.

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.

Timeline

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)

Treatment Details

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.

Participant Groups

Group I: Patients with ALS Experimental Treatment 1 Intervention

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

Group II: Healthy participants Experimental Treatment 1 Intervention

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

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

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University