Low-Dose Radiotherapy for Alzheimer's Disease
This study is testing a treatment called Low Dose Radiation Therapy (LDRT) for people with Alzheimer's disease or dementia that has inflammation. The main goal is to see how safe this treatment is and if people can tolerate it well. You might be able to join if you are 50 years or older and have a confirmed diagnosis of Alzheimer's disease. The study will look for any serious side effects during the treatment period, which lasts about 13 to 15 months. The study plans to enroll 50 participants, but its current status is unclear.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It aims to enroll 50 participants.
- What's involved
- Participants will receive an initial course of Low Dose Radiation Therapy (LDRT) over 10 fractions, followed by monthly maintenance LDRT for 12 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- Safety will be monitored from the first treatment through 30 days after the final monthly maintenance fraction, for approximately 13 to 15 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Low-Dose Radiotherapy for Alzheimer's Disease
At a glance
Conditions
NCT07693140
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Renaissance Institute of Precision Oncology & Radiosurgery
Winter Park, Floridastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Evan Thomas, MD, PhD · PRINCIPAL_INVESTIGATOR · Renaissance Institute of Precision Oncology and Radiosurgery
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Safety, As Measured By Incidence of Grade 3 or Higher Treatment-Related Adverse EventsFrom the first induction radiotherapy fraction through 30 days after the final monthly maintenance fraction (acute monitoring period), approximately 13 to 15 months
The primary endpoint is the proportion of participants who experience at least one treatment-related adverse event of Grade 3 or higher, graded per the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Adverse events are assessed continuously and attributed to study treatment (induction plus monthly maintenance low-dose whole-brain radiotherapy) by the investigator. Feasibility is defined by an acceptable rate of Grade 3 or higher treatment-related events: 15% or lower during the Phase I lead-in (first 10 participants) and 20% or lower across the full study population (N=50). Safety is monitored continuously using a Bayesian Beta-Binomial model; the study pauses for Data Safety Monitoring Board review if the posterior probability that the true Grade 3 or higher rate exceeds 20% reaches 0.80 or greater.