Clinical trial NCT03352258: Effect of Low Dose Radiotherapy on Brain Amyloidosis in the Treatment of Alzheimer's Disease
Official title: Effect of Low Dose Radiotherapy on Brain Amyloidosis in the Treatment of Alzheimer's Disease: a Randomized Pilot Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Alzheimer Disease
Keywords: Alzheimer's Disease
Amyloid
Radiotherapy
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2017-11-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, monocentric, prospective pilot study, pre- and post-intervention intraindividual comparison in the treated arm comparison of changes in neuropsychological performance in the treated and observational arms
Primary purpose: TREATMENT

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 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.


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;

Primary outcomes:
measure: Safety and adverse event associated with low dose brain RT
timeFrame: 12 months from end of RT
measure: Change in brain amyloid deposits
timeFrame: 8-12 weeks from end of RT
Secondary outcomes:
measure: Neuropsychological performances
timeFrame: 6 months after inclusion
Other outcomes:
Locations:
city: Geneva 14
country: Switzerland
facility: Geneva University Hospital
Study officials:
affiliation: University Hospital, Geneva
name: Valentina Garibotto, Pr
role: PRINCIPAL_INVESTIGATOR
References: