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

NCT03352258 | Completed

• 1 other identifier: 2017-01715
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease

Keywords

Alzheimer's Disease; Amyloid; Radiotherapy

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Neuropsychological performances

  6 months after inclusion

Study Arms (2)

Observation

NO INTERVENTION

Subjects in this arm will only be followed and not treated (observational arm)

Treatment arm

EXPERIMENTAL

Subjects will receive a low dose brain radiotherapy

Radiation: Low dose radiotherapy

Interventions

Low dose radiotherapy RADIATION

10 Gy in 5 fractions of 2 Gy on 5 consecutive days

Treatment arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 may not qualify if:

• 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;

Sponsors & Collaborators

• Valentina Garibotto: lead

Study Sites (1)

Geneva University Hospital

Geneva, 1211, Switzerland

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Valentina Garibotto, Pr

  University Hospital, Geneva

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Pr

Model Details: 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

Study Record Dates

• First Submitted: November 20, 2017
• First Posted: November 24, 2017
• Study Start: November 17, 2017
• Primary Completion: January 21, 2026
• Study Completion: January 21, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-03

Locations

CH (1)