NCT03352258 · ACTIVE NOT RECRUITING
Effect of Low Dose Radiotherapy on Brain Amyloidosis in the Treatment of Alzheimer's Disease
This small pilot study is testing whether low doses of radiation aimed at the brain can reduce amyloid plaques in people who already have early or prodromal Alzheimer's disease. Researchers will use a specialized PET scan to measure whether amyloid levels actually drop after a five-day radiation course. With only 10 patients, this is an early exploratory study — not yet proven safe or effective at scale, and nowhere near approval.
You may qualify if
- 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
You're excluded if
- 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;
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2025-01-09