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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03352258
Recruitment Status : Unknown
Verified April 2021 by Thomas Zilli, University Hospital, Geneva.
Recruitment status was:  Recruiting
First Posted : November 24, 2017
Last Update Posted : April 28, 2021
Information provided by (Responsible Party):
Thomas Zilli, University Hospital, Geneva

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.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Radiation: Low dose radiotherapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Low Dose Radiotherapy on Brain Amyloidosis in the Treatment of Alzheimer's Disease: a Randomized Pilot Study
Actual Study Start Date : November 17, 2017
Estimated Primary Completion Date : December 30, 2021
Estimated Study Completion Date : December 30, 2021

Arm Intervention/treatment
No Intervention: Observation
Subjects in this arm will only be followed and not treated (observational arm)
Experimental: Treatment arm
Subjects will receive a low dose brain radiotherapy
Radiation: Low dose radiotherapy
10 Gy in 5 fractions of 2 Gy on 5 consecutive days

Primary Outcome Measures :
  1. Safety and adverse event associated with low dose brain RT [ Time Frame: 12 months from end of RT ]
    Assess the number of patients who report adverse events

  2. Change in brain amyloid deposits [ Time Frame: 8-12 weeks from end of RT ]
    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

Secondary Outcome Measures :
  1. Neuropsychological performances [ Time Frame: 6 months after inclusion ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03352258

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Contact: Thomas Zilli, Dr. + 41 79 55 32 563 thomas.zilli@hcuge.ch
Contact: Garibotto Valentina, Dr. +41 79 55 34 459 valentina.garibotto@hcuge.ch

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Geneva University Hospital Recruiting
Geneva 14, Switzerland, 1211
Contact: Thomas Zilli, Dr.    + 41 79 55 32 563    thomas.zilli@hcuge.ch   
Contact: Valentina Garibotto, Dr.    +41 79 55 34 459    valentina.garibotto@hcuge.ch   
Sub-Investigator: Giovanni Frisoni, Pr         
Sponsors and Collaborators
Thomas Zilli
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Principal Investigator: Thomas Zilli, Dr. University Hospital, Geneva
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Responsible Party: Thomas Zilli, Dr., University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT03352258    
Other Study ID Numbers: 2017-01715
First Posted: November 24, 2017    Key Record Dates
Last Update Posted: April 28, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Thomas Zilli, University Hospital, Geneva:
Alzheimer's Disease
Additional relevant MeSH terms:
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Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Proteostasis Deficiencies
Metabolic Diseases