Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:39 PM
Ignite Modification Date:
2025-12-24 @ 7:39 PM
NCT ID:
NCT02405403
Eligibility Criteria:
Inclusion Criteria:
* Signed informed consent
* Age ≥ 18 years old
* Patient with probable or definite sporadic Amyotrophic Lateral Sclerosis (ALS) form according to the modified criteria of El Escorial
* Treated with riluzole 2 weeks
* Evolution less than 18 months
* Mini-Mental State Examination (MMS) score ≥ 26 and Frontal Assessment Battery (FAB) (normal)
* Affiliated to a social security system
Exclusion Criteria:
* Another unbalanced progressive pathology
* Vascular diseases (hypertension, diabetes, smoking, dyslipidemia) unbalanced
* Forced vital capacity \<75%
* Weight loss\> 10% of the weight before disease
* Status "low affinity binder" or "mixed affinity binder", the TSPO respect to the \[18 F\] DPA-714, which can interfere with the process of neuroinflammation: drugs with anti-inflammatory drugs (NSAIDs, corticosteroids, azathioprine, anti-tumor necrosis factor (TNF), antibiotics)
* Benzodiazepine in the week before the PET scan \[18F\] DPA-714 given the potential consequences for TSPO receivers
* Contraindications to MRI in patients with:
1. Metallic foreign body eye.
2. Any implanted electronic medical irremovably (pacemaker, neurostimulator, cochlear implants ...)
3. Metal heart valve,
4. Vascular clips formerly located on cranial aneurysm.
* Treatment in the month before the PET scan \[18F\] DPA-714 antagonist N-methyl-D-aspartate (NMDA) (memantine)
* Pregnant women, lactating women, and women in age for procreation and without reliable contraception or without history of hysterectomy
* ◦Person under guardianship
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02405403
Study Brief:
Protocol Section:
NCT02405403