Pyruvic acid for Amyotrophic lateral sclerosis (ALS) | Transient ischemic attack (TIA)

Inclusion criteria

• {"criterion_text":"- All participants: 1) Age 18-85 years.\n- All participants: 2) Pre-menopausal women must be confirmed non-pregnant by an onsite test.\n- ALS group: 1) Fulfilling the 2021 Gold Coast criteria.\n- ALS group: 2) Upper motor neuron symptoms.\n- TIA-group: 1) TIA within the last 10 days.\n- TIA-group: 2) Symptoms must include unilateral weakness of limb or face.\n- TIA-group: 3) Duration af symptoms minimum 10 minutes"}

Exclusion criteria

• {"criterion_text":"- Contraindications for MRI with contrast: Chronic kidney disease\n- Significant cardiac disease such as severe left ventricular outflow obstruction\n- Significant obstructive lung disease or severe asthma\n- Pacemaker, neurostimulator or cholera implant\n- Metal foreign bodies such as fragments and irremovable piercings\n- Unsafe medical implants (safety of heart valves, hips and the like must be confirmed)\n- Intracranial clips or coils\n- Claustrophobia\n- Largest circumference including arms > 160 cm.\n- Competing neurological, psychiatric, liver or systemic disease including diabetes (except prior TIA, unspecific brain MRI findings, hypertension, atherosclerosis and hyperlipidemia/cholesterolemia which are allowed).\n- Allergy to pyruvate."}

Primary endpoints

• {"endpoint_text":"- Cerebral metabolism as assesed with 13C label exchange from hyperpolarized pyruvate to bicarbonate, lactate and alanine","definition_or_measurement_approach":"Assessed with 13C label exchange from hyperpolarized pyruvate to bicarbonate, lactate and alanine (hyperpolarized 13C MRI metabolic measurement)."}

Secondary endpoints

• {"endpoint_text":"- Disease characterization from clinical exsamination, interviews and patient records.","definition_or_measurement_approach":"Disease characterization performed using clinical examination, interviews and review of patient records."}

Denmark

Earliest CTIS Part Ii Submission Date

03-09-2024

Latest Decision Or Authorization Date

12-09-2024

Processing Time Days

9

Number Of Sites

1

Number Of Participants

46

Primary sponsor

Full Name

Aarhus Universitet

Organisation Type

Educational Institution

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Aarhus Universitet","duties_or_roles":"sponsorDuties code: 1","organisation_type":"Educational Institution"}