Alzheimer DiseaseNCT03352258
Effect of Low Dose Radiotherapy on Brain Amyloidosis in the Treatment of Alzheimer's Disease
A study testing Low dose radiotherapy in people with Alzheimer Disease, run by Valentina Garibotto at 1 site in Switzerland.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Low dose radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- 17 Nov 2017to 21 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Previous therapeutic brain irradiation
Show all 17Show fewer
- 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;
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Low Dose Radiotherapy on Brain Amyloidosis in the Treatment of Alzheimer's Disease: a Randomized Pilot Study
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
- Being tested
- Low dose radiotherapy
- Keywords
- Alzheimer's Disease, Amyloid, Radiotherapy
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose radiotherapyRadiation
10 Gy in 5 fractions of 2 Gy on 5 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| Observation | No intervention | Subjects in this arm will only be followed and not treated (observational arm) |
| Treatment arm | Experimental | Subjects will receive a low dose brain radiotherapy Receives: Radiation: Low dose radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and adverse event associated with low dose brain RT
Assess the number of patients who report adverse events
Measured: 12 months from end of RT
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
Measured: 8-12 weeks from end of RT
Secondary outcomes (1)
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
Measured: 6 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2017
- Study start17 Nov 2017
- Primary completion21 Jan 2026
- Study completion21 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valentina Garibotto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Valentina Garibotto, University Hospital, Geneva
- Investigators
- Valentina Garibotto, Pr, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03352258
- Sponsor's protocol ID
- 2017-01715
- Other IDs
- 2017
- Status last verified
- Mar 2026
- First submitted
- 20 Nov 2017
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low Dose Radiotherapy on Brain Amyloidosis in the Treatment of Alzheimer's Disease: a Randomized Pilot Study
- ClinicalTrials.gov ID
- NCT03352258
- Acronym / sponsor ID
- 2017-01715
- Conditions
- Alzheimer Disease
- Keywords
- Alzheimer's Disease, Amyloid, Radiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Valentina GaribottoUniversity, hospital or other
- Study start
- 17 Nov 2017 (actual)
- Primary completion
- 21 Jan 2026 (actual)
- Study completion
- 21 Jan 2026 (actual)
- First posted
- 24 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Observation | No intervention | –Subjects in this arm will only be followed and not treated (observational arm) |
| Treatment arm | Experimental | Radiation: Low dose radiotherapySubjects will receive a low dose brain radiotherapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low dose radiotherapy10 Gy in 5 fractions of 2 Gy on 5 consecutive days | Radiation | Treatment arm |
Primary outcome
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
1 secondary outcome
Neuropsychological performances
Time frame: 6 months after inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valentina Garibotto, Pr principal investigator
University Hospital, Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low dose radiotherapy in people with Alzheimer Disease, run by Valentina Garibotto at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and adverse event associated with low dose brain RT (time frame: 12 months from end of RT). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.