The Safety and Scientific Validity of Low-dose Whole Brain Radiotherapy in Alzheimer's Disease.
- Conditions
- Alzheimer Disease
- Interventions
- Radiation: low dose whole brain radiation to treat Alzheimer disease
- Registration Number
- NCT04203121
- Lead Sponsor
- Kyung Hee University Hospital at Gangdong
- Brief Summary
Alzheimer's disease is the most frequent neurocognitive disorder associated with dementia, with a constantly increasing prevalence associated with an aging population. Amyloid deposition is considered as the first molecular event on the onset of Alzheimer's disease. It has already been demonstrated that low-dose radiotherapy is capable of reducing Alzheimer's disease-associated amyloid-β plaques and improving cognitive function in an animal model. In human, low-dose radiotherapy has demonstrated effectiveness in reducing bronchial amyloidosis.
The present study aims to conduct research by including 10 patients with a diagnosis of mild or moderately severe Alzheimer's disease and with evidence of amyloid pathology. Furthermore, the aim is to demonstrate the effectiveness of low-dose radiotherapy in reducing amyloid deposits in the human brain using molecular imaging (Flutemetamol(18F) PET) along with treatment of the specific target.
- Detailed Description
The investigators decided to use fractionated whole brain radiation doses of 1.8 Gy x 5 and 1.8 Gy x 3. Subjects will be followed with neurocognitive testing at 6 months post radiotherapy.
subjects 1-5 - 9Gy in 5 daily fractions
subjects 6-10 - 5.4Gy in 3 daily fractions
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 10
- Clinical diagnosis of mild or moderate Alzheimer's disease.
- Amyloid PET scan positivity.
- Korean Mini-Mental State Examination score ≥10 and ≤24.
- Clinical dementia rating scale 0.5, 1 or 2.
- Ability to undergo neurocognitive assessment at baseline visit, alone or accomparined by a caregiver.
- Ability to understand the clinical trial and give an informed consent
- previous therapeutic whole brain irradiation
- Evidence of seizure activity
- Evidence of active dermatological skin disease of the scalp.
- History of malignant tumors.
- Pregnant or breastfeeding.
- If the researcher determines that participation in this study is inadequate because of other findings that are considered clinically important.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description arm1 low dose whole brain radiation to treat Alzheimer disease An initial 5 patients will be enrolled in the first treatment scheme and will be followed for 6 months after completion of treatment to assess safety and any toxicity events associated with treatment. subjects 1-5 : 9 Gy in 5 fractions of 1.8 Gy on 5 consecutive days arm2 low dose whole brain radiation to treat Alzheimer disease Subjects in this arm will be enrolled in the second treatment scheme and will be followed for 6 months after completion of treatment to assess safety and any toxicity events associated with treatment. subjects 6-10 : 5.4 Gy in 3 fractions of 1.8 Gy on 3 consecutive days
- Primary Outcome Measures
Name Time Method Evaluate low-dose whole brain radiotherapy in subjects with early Alzheimer's dementia using neurocognitive testing methods 6 months after the first visit. verification of radiation therapy effect through GDS test
- Secondary Outcome Measures
Name Time Method change in brain amlyoid deposits 6 months after the first visit The change in SUV of the frontal, parietal, extramedullary, pre-wedge, and posterior fasciocutaneous flutemetamol (18F) PET is considered to be an effective response if the change in SUV is more than 5%.
Trial Locations
- Locations (1)
Kyung Hee University Hospital at Gangdong
🇰🇷Seoul, Korea, Republic of