Could tiny doses of radiation slow Alzheimer's? a new trial investigates

NCT ID NCT07693140

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

May 2029

An estimate. End dates often move.

Lead sponsor

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

50 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Renaissance Institute of Precision Oncology & Radiosurgery

    RECRUITING

    Winter Park, Florida, 32789, United States

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