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:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 12:10 AM
NCT ID:
NCT03352258
Eligibility Criteria:
Inclusion Criteria:
* Ability to understand the clinical trial and give an informed consent
* Clinical diagnosis of prodromal AD, or mild or moderate AD
* Ability to undergo neurocognitive assessment at baseline visit, alone or accompanied by a caregiver
* Amyloid PET scan positivity
* Ability to follow the 5-days RT regiment, alone or accompanied by a caregiver
Exclusion Criteria:
* Inclusion in another disease modifying clinical trial
* Previous therapeutic brain irradiation
* Evidence of vascular cognitive impairment on Magnetic Resonance Imaging (MRI) (Fazekas score \>1 and Wahlund score \>=10/30)
* Oncologic disease (excluding skin cancer) active or in remission from less than 5 years
* Evidence of substance abuse (alcohol and/or other drugs) with a dependence during the previous 12 months (DSM-IV criteria)
* Presence of subdural hygroma's, subdural hematomas or hydrocephalus
* Significant psychiatric comorbidity as assessed during the clinical evaluation by the neurologist/geriatrician in charge
* Active or recent (within 3 months) cerebral infection/haemorrhage
* Immunocompromised status
* Prior history of seizure
* Dermatological skin disease of the scalp
* Women who are pregnant or breast feeding or who intend to become pregnant during the course of the study;
* Lack of safe contraception, defined as: female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03352258
Study Brief:
Protocol Section:
NCT03352258