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A Study Testing Whether Low-Dose Radiation Could Help the Immune System and Possibly Improve Early-Onset Alzheimer's Disease.
Sponsor: Heinrich-Heine University, Duesseldorf
Summary
The goal of this randomized clinical trial is to investigate whether low-dose whole-brain radiotherapy has a potential immunomodulatory effect that may influence disease progression in patients with early-stage Alzheimer's disease (ICD-10 diagnosed). The main question(s) it aims to answer are: Does low-dose radiotherapy have an effect on cognitive function and disease progression in early Alzheimer's disease? Is the intervention safe and feasible in this patient population under clinical trial conditions? If there is a comparison group: Researchers will compare patients receiving low-dose whole-brain radiotherapy to a control group receiving a sham or non-active treatment, to assess potential differences in cognitive outcomes and disease-related parameters over time. Participants will: Undergo baseline diagnostic assessments including neuropsychological testing, MRI, EEG, and laboratory tests Be randomly assigned to one of two study groups Receive either low-dose whole-brain radiotherapy (6 sessions over 3 weeks) or a control condition Attend follow-up visits at 6 weeks, 3 months, and 6 months including repeated cognitive testing and clinical assessments
Official title: A Randomized Clinical Feasibility Trial Investigating Low-Dose Radiotherapy as an Immunomodulatory Therapeutic Modality for Early-Onset Alzheimer's Disease: A Pilot Investigation
Key Details
Gender
All
Age Range
50 Years - Any
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2026-05-15
Completion Date
2028-05-31
Last Updated
2026-05-04
Healthy Volunteers
No
Interventions
Low-Dose Whole-Brain Radiotherapy
Participants receive low-dose whole-brain radiotherapy delivered using external beam photon radiation. The treatment is applied in a fractionated schedule over approximately three weeks (6 treatment sessions). A dedicated planning CT scan is performed prior to treatment for dose calculation and treatment planning purposes. Irradiation is performed according to institutional radiotherapy protocols under standard quality assurance procedures.
Control Condition (No Radiotherapy)
Participants in this arm do not receive radiotherapy or any study-specific therapeutic intervention. Instead, they undergo the same schedule of clinical and neuropsychological assessments as the intervention group, including baseline and follow-up visits over the same study period. This arm serves as a comparator to evaluate changes in clinical and cognitive outcomes over time in the absence of low-dose whole-brain radiotherapy.
Locations (1)
Klinik für Strahlentherapie und Radioonkologie
Düsseldorf, North Rhine-Westphalia, Germany