The safety and scientific validity of low-dose whole brain radiotherapy on brain amyloidosis during the treatment of mild or moderate Alzheimer’s disease.
- Conditions
- Diseases of the nervous system
- Registration Number
- KCT0003582
- Lead Sponsor
- Kyung Hee University Hosipital at Gangdong
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 10
1. Clinical diagnosis of mild or moderate Alzheimer's disease.
2. Amyloid PET(positron emission tomography scan) positivity.
3. Korean Mini-Mental State Examination score =10 and =24.
4. Clinical dementia rating scale 0.5, 1 or 2.
5. Male and female subjects aged 50 to 85 years.
6. Able to complete neurocognitive function assessments, psychological function assessments, and QOL(Quality of Life) assessments administered at the screening visit.
7. Subjects with a caregiver who provided information about the overall status of the subject and the changes in cognitive function and function.
8. Signed by research subject or guardian who understands the qualifications for the study and signs the consent form.
1. Current or past history of whole brain radiotherapy
2. Evidence of seizure activity
3. Evidence of active dermatological skin disease of the scalp.
4. History of malignant tumors.
5. Pregnant or breastfeeding.
6. If the researcher determines that participation in this study is inadequate because of other findings that are considered clinically important.
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method After first visitng 6months , evaluate for scoring change compared with baseline study using neurocognitive testing methods (K-MMSE(Korean Mini Mental State Examination), verbal memory, visual memory, Korean version-Boston Naming Test, Clock Drawing Test, Controlled Oral Word Association Test, Stroop Test).;The change in SUV of flutametamol (18F) amyloid PET on the Frontal, Posterior cingulate and Precuneous, Lateral Temporal region, Parietal lobe, Striatum.
- Secondary Outcome Measures
Name Time Method For verifying of adverse effect about headache, nausea, vomiting,anorexia,general fatigue, redness and itching of scalp,alopecia