NCT03352258Completed
Effect of Low Dose Radiotherapy on Brain Amyloidosis in the Treatment of Alzheimer's Disease
Effect of Low Dose Radiotherapy on Brain Amyloidosis in the Treatment of Alzheimer's Disease: a Randomized Pilot Study
Source: ClinicalTrials.gov · Last updated 28 Apr 2026
Brief summary (registry, in English)
Alzheimer's Disease (AD) is the most frequent neurodegenerative disease associated with dementia, with a constantly increasing prevalence associated with an aging population. Amyloid deposition is considered the first molecular event occurring in AD: as already showed in an animal model, a low-dose radiotherapy (RT) course is capable of reducing AD-associated amyloid-β plaques and improve cognitive function. This pilot study wishes to investigate in 10 patients with a diagnosis of prodromal or early probable AD and with evidence of amyloid pathology the effectiveness of a short course low dose RT radiotherapy to reduce amyloid deposits in the human brain using molecular imaging (18F-Florbetapir) to show the effectiveness of the treatment on the specific target.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 20 Nov 2017
- Start date
- 17 Nov 2017
- Primary completion date
- 21 Jan 2026
- Lead sponsor
- Valentina Garibotto
- Diseases
- Amyloidosis, Alzheimer disease
- NCT number
- NCT03352258
What you commit to
- Study type: Interventional
- Participants enrolled: 20
- From 17 Nov 2017 to the primary completion date, 21 Jan 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous therapeutic brain irradiation
- Evidence of substance abuse (alcohol and/or other drugs) with a dependence during the previous 12 months (DSM-IV criteria)
- Prior history of seizure
Other illness
- Inclusion in another disease modifying clinical trial
- 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
- Significant psychiatric comorbidity as assessed during the clinical evaluation by the neurologist/geriatrician in charge
- Active or recent (within 3 months) cerebral infection/haemorrhage
- Dermatological skin disease of the scalp
Other
- Presence of subdural hygroma's, subdural hematomas or hydrocephalus
- Immunocompromised status
- 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;
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Geneva University Hospital Coordinator of this site? Confirm its status | Geneva | Switzerland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.