Status:
ACTIVE_NOT_RECRUITING
Effect of Low Dose Radiotherapy on Brain Amyloidosis in the Treatment of Alzheimer's Disease
Lead Sponsor:
Valentina Garibotto
Conditions:
Alzheimer Disease
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
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 con...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
November 17 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03352258
Start Date
November 17 2017
End Date
December 30 2027
Last Update
January 9 2025
Active Locations (1)
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1
Geneva University Hospital
Geneva, Switzerland, 1211