Could tiny doses of radiation slow Alzheimer's? a new trial investigates
NCT ID NCT07693140
First seen Jul 09, 2026 · Last updated Jul 10, 2026 · Updated 1 time
Summary
This study tests whether very low doses of radiation delivered to the whole brain are safe and can help preserve thinking and memory in people with Alzheimer's disease or certain dementias with inflammation. Participants receive an initial course of 10 radiation sessions, followed by monthly maintenance treatments for a year. The trial aims to see if this approach can calm brain inflammation and slow cognitive decline.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Low-dose whole-brain radiotherapy
- What this could lead to
- If successful, this could offer a new way to slow memory loss and cognitive decline in Alzheimer's disease by calming brain inflammation.
- What could go wrong
- This is an early-phase trial with only 50 participants, so results may not apply widely. Radiation to the brain carries risks of side effects like headache or fatigue, and the treatment may not improve cognition.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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May 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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50 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age ≥50 years at time of enrollment 2. Externally confirmed diagnosis by a neurologist or geriatric psychiatrist (at Renaissance Institute, collaborating neurologist Dr. Sherif Makar, MD of Charis Neurology is available for diagnostic consultation) of one of the following: a. Alzheimer's disease (per NIA-AA 2011 or 2018 criteria) b. Frontotemporal dementia with documented inflammatory features c. Dementia with Lewy bodies with elevated inflammatory CSF markers d. Other neurodegenerative dementia with confirmed inflammatory component (elevated CSF IL-6, IL-1β, or TNF-α; or neuroimaging evidence of neuroinflammation) 3. MoCA score 10-25 at baseline screening (moderate-to-mild cognitive impairment range) 4. Karnofsky Performance Status (KPS) ≥60 or ECOG Performance Status ≤2 5. Medically stable and capable of receiving radiation therapy as assessed by the treating radiation oncologist 6. Reliable caregiver or informant able to accompany the patient to ≥80% of scheduled visits 7. Written informed consent from patient (if decision-making capacity is preserved) and/or legally authorized representative (LAR); caregiver co-consent required 8. Life expectancy ≥18 months in the opinion of the treating physician 9. Ability and willingness to comply with monthly clinic visits for the 12-month maintenance period \-------------------------------------------------------------------------------------- Exclusion Criteria: 1. Prior whole brain or partial brain radiotherapy of any dose at any time 2. Active systemic malignancy requiring concurrent oncologic treatment 3. Implanted device contraindicated with radiation therapy (pacemaker, cochlear implant, deep brain stimulator, or equivalent) 4. Brain MRI demonstrating any of the following: (a) more than 4 cerebral microhemorrhages on susceptibility-weighted imaging (SWI) or gradient echo (GRE) sequences; (b) more than 1 area of superficial cortical siderosis; (c) severe white matter disease (Fazekas grade 3); or (d) any macrohemorrhage or hemosiderin-stained lesion \>10 mm. These thresholds are adapted from established AD trial imaging exclusion criteria to minimize enrollment of patients with advanced cerebrovascular disease or pre-existing hemorrhagic risk factors. 5. Known active cerebral amyloid angiopathy-related inflammation (CAA-ri) or amyloid-related beta-angiitis (ABRA), whether confirmed by biopsy, CSF analysis, or neuroimaging features consistent with active leptomeningeal or parenchymal amyloid-related inflammation 6. Active autoimmune encephalitis in acute phase (patients in stable chronic phase are eligible) 7. Uncontrolled systemic infection or active sepsis at enrollment 8. Severe psychiatric comorbidity (active psychosis, active suicidal ideation) impairing protocol compliance or safety assessment 9. Concurrent enrollment in another interventional trial targeting cognitive decline or neuroinflammation 10. Pregnancy or lactation; women of childbearing potential must use adequate contraception 11. Inability to lie flat and still for radiation delivery (approximately 10-15 minutes per session) 12. MoCA \<10 at baseline screening (severe dementia; insufficient cognitive range for endpoint assessment)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Renaissance Institute of Precision Oncology & Radiosurgery
RECRUITINGWinter Park, Florida, 32789, United States
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