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

NCT07564700 | Not Yet Recruiting DMC

• 1 other identifier: 2024-3055
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in the CERAD-Plus score

  The primary endpoint is the change in the CERAD-Plus score from baseline (t0) to 6 months, as well as from baseline to 3 months. This test assesses global cognitive performance, particularly with regard to memory and executive functions. Improvements at either of these time points indicate a positive effect of the intervention on cognitive performance and the course of Alzheimer's disease.

  Baseline, 3 months, and 6 months after randomization

Secondary Outcomes (4)

• Change in the MADRS and BDI-II scores

  Baseline, 6 weeks, 3 months, and 6 months after randomisation

• Change in the FWIT scores

  Baseline, 6 weeks, 3 months, 6 months

• Changes in EEG patterns

  Baseline, 6 weeks, 3 months, and 6 months after randomisation

• Toxicity of radiotherapy according to CTCAE v5

  Baseline to 6 months follow up

Study Arms (2)

Low-Dose Whole-Brain Radiotherapy (Intervention Arm)

EXPERIMENTAL

Participants in this arm receive low-dose whole-brain radiotherapy delivered using external beam radiotherapy.

Radiation: Low-Dose Whole-Brain Radiotherapy

Control Condition (Non-active Comparator)

SHAM COMPARATOR

Participants in this arm do not receive radiotherapy.

Other: Control Condition (No Radiotherapy)

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.

Low-Dose Whole-Brain Radiotherapy (Intervention Arm)

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.

Control Condition (Non-active Comparator)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Heinrich-Heine University, Duesseldorf: lead

Study Sites (1)

Klinik für Strahlentherapie und Radioonkologie

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Danny Jazmati, Priv.-Doz. Dr. med.

CONTACT

+492118106291; Danny.Jazmati@med.uni-duesseldorf.de

zahra khosravi

CONTACT

+492118106291; zahra.khosravi@med.uni-duesseldorf.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are blinded to treatment allocation. Treating physicians and radiotherapy staff are not blinded due to the nature of the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomly assigned in a 1:1 ratio to one of two parallel study arms. One group receives low-dose whole-brain radiotherapy as the active intervention, while the control group receives a non-active comparator condition. Both groups are followed over the same study period and undergo identical baseline and follow-up assessments, including neuropsychological testing and clinical evaluations. The study is conducted in a parallel-group design to allow comparison of outcomes between the intervention and control groups under comparable conditions.

Study Record Dates

• First Submitted: April 27, 2026
• First Posted: May 4, 2026
• Study Start (Estimated): May 15, 2026
• Primary Completion (Estimated): December 15, 2027
• Study Completion (Estimated): May 31, 2028
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)