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

NCT ID: NCT03352258

Last Updated: 2025-01-09

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-17
• Study Completion Date: 2027-12-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Observation

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Treatment arm

Subjects will receive a low dose brain radiotherapy

Group Type: EXPERIMENTAL

Low dose radiotherapy

Intervention Type: RADIATION

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

Interventions

Low dose radiotherapy

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

Intervention Type: RADIATION

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Valentina Garibotto

OTHER

Sponsor Role: lead

Responsible Party

Valentina Garibotto

Pr

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Valentina Garibotto, Pr

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Geneva

Locations

Geneva University Hospital

Geneva, , Switzerland

Countries

Switzerland

Other Identifiers

2017-01715

Identifier Type: -

Identifier Source: org_study_id