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The safety and scientific validity of low-dose whole brain radiotherapy on brain amyloidosis during the treatment of mild or moderate Alzheimer’s disease.

Not Applicable
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
Inclusion Criteria

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.

Exclusion Criteria

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
NameTimeMethod
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
NameTimeMethod
For verifying of adverse effect about headache, nausea, vomiting,anorexia,general fatigue, redness and itching of scalp,alopecia
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