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

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

Interventions

• Low-Dose Whole-Brain Radiotherapy · RADIATION

  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) · OTHER

  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.

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

Inclusion Criteria:

Alzheimer's diagnosis according to ICD-10 Ability to understand the clinical study and provide informed consent Early-onset disease Age older than 50 years Stable treatment with anti-dementia medication for at least 3 months

Exclusion Criteria:

* Prodromal Alzheimer's disease Mild cognitive impairment (MCI) Severe psychiatric disorders that could interfere with participation in the study Unstable or recently changed medication therapy Other neurodegenerative diseases or severe neurological disorders Uncontrolled chronic diseases that could increase the risk of complications Previous therapeutic brain irradiation Evidence of vascular cognitive impairment on MRI (Fazekas score \>1 and Wahlund score ≥10/30) Oncological disease (except skin cancer), active or in remission for less than 5 years Evidence of substance abuse (alcohol and/or other drugs) with dependence within the last 12 months (DSM-IV criteria) Active or recent (within 3 months) cerebral infection or hemorrhage Immunocompromised status History of seizures Dermatological scalp disease Women who are pregnant, breastfeeding, or planning to become pregnant during the study period Patient has a history of cancer (except non-melanoma skin cancer) Patient is taking antiepileptic medication Patient and legally authorized representative are unable to provide informed consent Patient with a history of focal neurological deficits (except vibratory peripheral neuropathy)

Sites (1)

• Klinik für Strahlentherapie und Radioonkologie, Düsseldorf, North Rhine-Westphalia, Germany