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

Primary Purpose

Alzheimer Disease

Status

Unknown status

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

Low dose radiotherapy

About this trial

This is an interventional treatment trial for Alzheimer Disease focused on measuring Alzheimer's Disease, Amyloid, Radiotherapy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

Geneva University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Observation

Treatment arm

Arm Description

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

Subjects will receive a low dose brain radiotherapy

Outcomes

Primary Outcome Measures

Safety and adverse event associated with low dose brain RT

Assess the number of patients who report adverse events

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT03352258

First Posted

November 20, 2017

Last Updated

April 27, 2021

Sponsor

Thomas Zilli

1. Study Identification

Unique Protocol Identification Number

NCT03352258

Brief Title

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

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Unknown status

Study Start Date

November 17, 2017 (Actual)

Primary Completion Date

December 30, 2021 (Anticipated)

Study Completion Date

December 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Thomas Zilli

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer Disease

Keywords

Alzheimer's Disease, Amyloid, Radiotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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)

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Observation

Arm Type

No Intervention

Arm Description

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

Arm Title

Treatment arm

Arm Type

Experimental

Arm Description

Subjects will receive a low dose brain radiotherapy

Intervention Type

Radiation

Intervention Name(s)

Low dose radiotherapy

Intervention Description

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

Primary Outcome Measure Information:

Title

Safety and adverse event associated with low dose brain RT

Description

Assess the number of patients who report adverse events

Time Frame

12 months from end of RT

Title

Change in brain amyloid deposits

Description

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

Time Frame

8-12 weeks from end of RT

Secondary Outcome Measure Information:

Title

Neuropsychological performances

Description

Time Frame

6 months after inclusion

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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;

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Thomas Zilli, Dr.

Phone

+ 41 79 55 32 563

thomas.zilli@hcuge.ch

First Name & Middle Initial & Last Name or Official Title & Degree

Garibotto Valentina, Dr.

Phone

+41 79 55 34 459

valentina.garibotto@hcuge.ch

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thomas Zilli, Dr.

Organizational Affiliation

University Hospital, Geneva

Official's Role

Principal Investigator

Facility Information:

Facility Name

Geneva University Hospital

City

Geneva 14

ZIP/Postal Code

1211

Country

Switzerland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Thomas Zilli, Dr.

Phone

+ 41 79 55 32 563

thomas.zilli@hcuge.ch

First Name & Middle Initial & Last Name & Degree

Valentina Garibotto, Dr.

Phone

+41 79 55 34 459

valentina.garibotto@hcuge.ch

First Name & Middle Initial & Last Name & Degree

Giovanni Frisoni, Pr

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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