Effect of Low Dose Radiotherapy on Brain Amyloidosis in the Treatment of Alzheimer's Disease
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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
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Condition or disease | Intervention/treatment | Phase |
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Alzheimer Disease | Radiation: Low dose radiotherapy | Not Applicable |
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)
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Experimental: Treatment arm
Subjects will receive a low dose brain radiotherapy
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Radiation: Low dose radiotherapy
10 Gy in 5 fractions of 2 Gy on 5 consecutive days |
- 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
- 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
- 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

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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;

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
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 |
Switzerland | |
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 |
Principal Investigator: | Thomas Zilli, Dr. | University Hospital, Geneva |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Alzheimer's Disease Amyloid Radiotherapy |
Alzheimer Disease Amyloidosis Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders Proteostasis Deficiencies Metabolic Diseases |