Alzheimer’s disease
Conditions
Interventions
Control Group1:Patients received conventional AD pharmacological treatment alongside sham RT (0 cGy/day, twice weekly, totaling 0 cGy over 3 weeks with 6 sessions). Patients in the sham RT group under
Experimental Group1:Low-Dose Whole-Brain Radiotherapy + Standard Medication:After enrollment, patients were subjected to conventional pharmacological treatment for Alzheimer’s disease (AD) while concu
Experimental Group2:Low-Dose Whole-Brain Radiotherapy + Standard Medication:After enrollment, patients were subjected to conventional pharmacological treatment for Alzheimer’s disease (AD) while concu
Control Group2:Patients received conventional AD pharmacological treatment alongside sham RT (0 cGy/day, twice weekly, totaling 0 cGy over 3 weeks with 6 sessions). Patients in the sham RT group under
Experimental Group3:Low-Dose Whole-Brain Radiotherapy + Standard Medication:After enrollment, patients were subjected to conventional pharmacological treatment for Alzheimer’s disease (AD) while concu
Sponsors
The First Affiliated Hospital of the Air Force Medical University
Eligibility
Sex/Gender
All
Age
55 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Aged between 55 and 85 years, regardless of sex; 2. Diagnosed with Alzheimer’s disease (AD) according to the 2023 National Institute on Aging and Alzheimer’s Association (NIA-AA) criteria and the 2024 Expert Consensus; 3. Stable maintenance of standard AD pharmacotherapy (donepezil, galantamine, rivastigmine, or memantine) for at least 3 months; 4. Confirmed elevated amyloid levels and tau positivity via positron emission tomography (PET) or cerebrospinal fluid (CSF) analysis prior to screening; For participants aged 55–64 years, at least one additional risk factor is required (due to the relatively lower prevalence of amyloid positivity in this age group): 1)First-degree relative diagnosed with dementia before the age of 75, or 2) Presence of at least one apolipoprotein E4 (APOE4) allele, or 3)Prior confirmation of elevated cerebral amyloid levels via plasma biomarker testing, PET imaging, or CSF analysis; 5. Ability to undergo cognitive function tests and imaging examinations; 6. Availability of a caregiver to provide information on the participant’s overall condition, cognitive function, and functional changes; 7. Provision of written informed consent by the participant or caregiver for trial participation.
Exclusion criteria
Exclusion criteria: 1. History of therapeutic brain radiation; 2. History of epileptic seizures within the past 10 years prior to screening; 3. Presence of dermatological conditions on the scalp; 4. History of malignancy; 5. Pregnancy or lactation; 6. Cognitive decline attributable to pharmacological or neurological/neurodegenerative conditions other than AD (e.g., substance abuse, vitamin B12 deficiency, thyroid dysfunction, stroke or other cerebrovascular diseases, dementia with Lewy bodies (DLB), frontotemporal dementia, or head trauma); 7. Clinically significant unstable psychiatric disorders within the past 6 months (e.g., uncontrolled depression, schizophrenia, or bipolar disorder); 8. Brain MRI findings demonstrating any of the following: (1) Acute or subacute hemorrhage, (2)Prior macrohemorrhage (defined as >1 cm in diameter on T2-weighted sequences), (3)Prior subarachnoid hemorrhage (unless documented as unrelated to underlying tructural or vascular abnormalities), (4)More than 4 microhemorrhages, (5) Cortical infarction (defined as >1.5 cm in diameter, regardless of anatomical location), (6)More than one lacunar infarction (defined as >1.5 cm in diameter), (7)Superficial siderosis, (8)Diffuse white matter disease (rated as grade 3 on the age-related white matter changes scale). Additionally, any MRI findings deemed by the investigator to potentially contribute to dementia, pose risks to the participant, or impede adequate safety monitoring—including contraindications to MRI (e.g., cardiac pacemakers/defibrillators, ferromagnetic metal implants)—will also warrant exclusion. 9. Medical, psychological, or physiological conditions that, in the investigator’s judgment, may compromise the participant’s ability to complete the study or comprehend the patient handbook.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Alzheimer's Disease Assessment Scale-Cognitive Subscale Score(ADAS-cog) (Mild-to-Moderate Patients);Severe Impairment Battery Score (Severe Cases); | — |
Secondary
| Measure | Time frame |
|---|---|
| Mini-Mental State Examination;Clinical Dementia Rating Score;Neuropsychiatric Inventory;Montreal Cognitive Assessment;Activities of Daily Living Score;Magnetic resonance imaging;adverse events; | — |
Countries
China
Contacts
Public ContactLina Zhao
Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University
Outcome results
None listed