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A Study Testing Whether Low-Dose Radiation Could Help the Immune System and Possibly Improve Early-Onset Alzheimer's Disease.

NCT07564700 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-05-04

No results posted yet for this study

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

Conditions

  • Alzheimer Disease (AD)
  • Early Onset Alzheimer Disease

Interventions

RADIATION

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.

OTHER

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.

Sponsors & Collaborators

  • Heinrich-Heine University, Duesseldorf

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-15
Primary Completion
2027-12-15
Completion
2028-05-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07564700 on ClinicalTrials.gov