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NCT Number: NCT03352258

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Geneva University Hospital

Geneva, 1211, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Low dose radiotherapy

Radiation

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Valentina Garibotto

Other

Registry information

Official study title

Effect of Low Dose Radiotherapy on Brain Amyloidosis in the Treatment of Alzheimer's Disease: a Randomized Pilot Study

Important dates

Study start
2017
Primary completion
2026
Study completion
2026
First posted
Nov 24, 2017
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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