New scan could spot ALS sooner, study shows promise
NCT ID NCT05974579
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new PET imaging tracer to see if it can safely show signs of ALS in the body. Eight people (some healthy, some with ALS) received the tracer and were scanned. The goal was to check safety and how the tracer spreads, which could lead to earlier diagnosis and better tracking of the disease.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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8 people
The number who actually took part.
- Started
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Nov 2023
- Finished
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Mar 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Aged of: 1. For healthy participants: Male or female subjects aged 50 years or older 2. For ALS patients: Male or female subjects aged 18 years and older 2. Able to remain in a lying position for up to 45 minutes without respiratory support. 3. A) For ALS patients, confirmed diagnostic of definitive ALS according to El-Escorial criteria14 B) for healthy participants: no neurologic condition (confirmed by physical exam) 4. Have venous access sufficient to allow for blood sampling 5. Are reliable and willing to make themselves available for the duration of the study and are willing to follow CRCHUS-specific study procedures. Exclusion Criteria: 1. Are currently enrolled or were enrolled in the last 12 weeks in any other clinical trial involving a study drug or off label use of a drug or device, or any other type of medical research judged not to be scientifically or medically compatible with this study. 2. Female participants who are pregnant or breast feeding; or women of childbearing potential (\<50 years old) and men who are sexually active who are not willing to use an accepted effective contraceptive method. 3. Plan to have surgery or other invasive procedure during the course of the study (up to 14 days post-injection) 4. Have a progressive medical illness including, but not limited to, any cardiovascular, hepatic, respiratory, hematological, endocrine, psychiatric or neurological disease, convulsions, or any clinically significant laboratory abnormality at screening and at first visit (D0) that, in the judgment of the medical doctor, indicate a medical problem that would preclude study participation. 5. Have one of these conditions (for both patient groups): 1. hepatic disorder such as hepatic encephalopathy, hepatic laboratory abnormalities (ALT or AST ≥3 × ULN or total bilirubin ≥2 × ULN) and hematology abnormalities at screening. 2. severe chronic kidney disease (eg, an estimated glomerular filtration rate \[eGFR\] \<30 mL/min/1.73m or requires chronic dialysis) at screening. 3. Have severe active psychiatric illness. 4. Have a diagnosis of another neurodegenerative disease (e.g. Parkinson disease, Alzheimer's disease, etc). 5. Have a significant infection or known inflammatory process on screening or at Day 0. 6. Alcohol or drug abuse based on patient auto-report 7. Have a history of relevant atopy or drug hypersensitivity or allergy to antibodies; 8. Have an abnormal blood pressure (supine) defined as a diastolic blood pressure \>90 or \<45 mmHg and/or a systolic blood pressure \>160 or \<90 mmHg. Re-testing may occur once during the screening visit within 2 hours of the initial abnormal blood pressure measurement at the discretion of the investigator. 6. For ALS patients: 1. Have undergone a tracheostomy for ALS symptoms. 2. Are on nasal intermittent positive pressure ventilation (NIPPV) \>4h during the day, while awake for the treatment of ALS related symptoms. 3. Have other causes of neuromuscular weakness. 7. Have received treatment with biologic agents (such as monoclonal antibodies, including marketed drugs and AP-101) within 3 months or 5 half-lives (whichever is longer) prior to study drug injection. 8. Have received any blood or blood products within the 3 months prior to screening. 9. Cannot communicate reliably with the investigator. 10. Are unwilling or unable to give written informed consent. 11. In the opinion of the medical doctor or his/her delegate, are unsuitable for inclusion in the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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CIUSSS de l'Estrie-CHUS Hospital
Sherbrooke, Quebec, J1H 5N4, Canada
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Other studies related to the condition(s) this trial covers.
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