Effect of Low Dose Radiotherapy on Brain Amyloidosis in the Treatment of Alzheimer's Disease

Alzheimer Disease Clinical Trial

Official title:

Effect of Low Dose Radiotherapy on Brain Amyloidosis in the Treatment of Alzheimer's Disease: a Randomized Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03352258
• Other study ID #: 2017-01715
• Status: Recruiting
• Phase: N/A
• Start date: November 17, 2017
• Est. completion date: December 30, 2021

Study information

• Verified date: April 2021
• Source: University Hospital, Geneva
• Contact: Thomas Zilli, Dr.
• Phone: + 41 79 55 32 563
• Email: thomas.zilli[@]hcuge.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 30, 2021
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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;

Related Conditions & MeSH terms

• Alzheimer Disease
• Amyloidosis

Intervention

Radiation:
• Low dose radiotherapy
10 Gy in 5 fractions of 2 Gy on 5 consecutive days

Locations

Country	Name	City	State
Switzerland	Geneva University Hospital	Geneva 14

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Zilli

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and adverse event associated with low dose brain RT	Assess the number of patients who report adverse events	12 months from end of RT
Primary	Change in brain amyloid deposits	Assess intra-individual change in a quantitative measure of amyloid deposits on PET imaging (Standard Uptake Value ratio) SUVR between amyloid PET scans before and after low dose brain RT	8-12 weeks from end of RT
Secondary	Neuropsychological performances	Neurocognitive tests (assessing verbal and non-verbal memory, attention, executive function, praxis function, visuospatial functions, and language) to evaluate changes after low dose RT, as compared with a population of 10 subjects followed up clinically	6 months after inclusion