An interventional study of low dose whole brain radiation to treat Alzheimer disease in Alzheimer Disease, sponsored by Kyung Hee University Hospital at Gangdong. Status unknown at 1 site in South Korea. Open to participants aged 50 Years to 95 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-20.
Sponsored by Kyung Hee University Hospital at Gangdong · Not applicable, Interventional, and Treatment
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.
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
3,766 studies on the registry are indexed under Alzheimer Disease; 882 are open to participants now.
This study's planned enrollment of 10 is below the median of 68 across 2,862 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Kyung Hee University Hospital at Gangdong is the lead sponsor of 23 studies on the registry; 1 is open to participants now.
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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
Radiation: 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
Radiation: 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
Evaluate low-dose whole brain radiotherapy in subjects with early Alzheimer's dementia using neurocognitive testing methods
verification of radiation therapy effect through GDS test
Time frame: 6 months after the first visit.
change in brain amlyoid deposits
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%.
Time frame: 6 months after the first visit
This study is status unknown, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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Kyung Hee University Hospital at Gangdong