G30 F00
Conditions
Interventions
Group 1: 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 tr
Sponsors
Uniklinkum Düsseldorf
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Inclusion criteria
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 Early to moderate Alzheimer’s stage (clinical manifestation of dementia, no prodromale phase) Stable treatment with anti-dementia medication for at least 3 months
Exclusion criteria
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) patients who are not able to give consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. [Time Frame: Baseline, 3 months, and 6 months after randomization] | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in the MADRS and BDI-II scores The Montgomery–Åsberg Depression Rating Scale (MADRS) captures objective changes, while the Beck Depression Inventory II (BDI-II) assesses subjective changes in possible depressive symptoms and mood. A reduction in BDI-II scores at any time point indicates an improvement in mental health, which may correlate with cognitive recovery. [Time Frame: Baseline, 6 weeks, 3 months, and 6 months after randomisation] Change in the FWIT scores The Color–Word Interference Test (FWIT) is used to measure changes in executive function and cognitive control. An increase in FWIT scores over these time periods indicates improved cognitive flexibility and inhibitory control. [Time Frame: Baseline, 6 weeks, 3 months, 6 months] Changes in EEG patterns Electroencephalography (EEG) is used to monitor changes in brain-wave patterns in order to assess neuronal function and synaptic plasticity. Improvements in EEG activity over time, such as an increase in alpha-wave activity, may indicate cognitive and functional recovery. [Time Frame: Baseline, 6 weeks, 3 months, and 6 months after randomisation] Toxicity of radiotherapy according to CTCAE v5 Radiotherapy-related toxicity is assessed using the Common Terminology Criteria for Adverse Events (CTCAE). This endpoint includes documenting and evaluating any side effects caused by the radiotherapy. [Time Frame: Baseline to 6 months follow up] | — |
Countries
Germany
Contacts
Public ContactDanny Jazmati
Uniklinikum Düsseldorf
Outcome results
None listed