The Safety and Scientific Validity of Low-dose Whole Brain Radiotherapy in Alzheimer's Disease.
NCT ID: NCT04203121
Last Updated: 2020-02-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
10 participants
INTERVENTIONAL
2019-04-01
2020-07-31
Brief Summary
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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.
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Detailed Description
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subjects 1-5 - 9Gy in 5 daily fractions
subjects 6-10 - 5.4Gy in 3 daily fractions
Conditions
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Study Design
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RANDOMIZED
PARALLEL
arm 2 :subjects 6-10 - 5.4Gy in 3 daily fractions
TREATMENT
NONE
Study Groups
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arm1
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
low dose whole brain radiation to treat Alzheimer disease
subjects 1-5 : 9Gy in 5 daily fractions
subjects 6-10 : 5.4Gy in 3 daily fractions
arm2
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
low dose whole brain radiation to treat Alzheimer disease
subjects 1-5 : 9Gy in 5 daily fractions
subjects 6-10 : 5.4Gy in 3 daily fractions
Interventions
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low dose whole brain radiation to treat Alzheimer disease
subjects 1-5 : 9Gy in 5 daily fractions
subjects 6-10 : 5.4Gy in 3 daily fractions
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
50 Years
95 Years
ALL
Yes
Sponsors
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Kyung Hee University Hospital at Gangdong
OTHER
Responsible Party
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Locations
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Kyung Hee University Hospital at Gangdong
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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KHNMC 2018-09-022-003
Identifier Type: -
Identifier Source: org_study_id
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