Detailed Information

Evaluation of Efficacy and Safety Using Low Dose Radiation Therapy with Alzheimer's Disease: A Protocol for Multicenter Phase II Clinical Trial

Cited 1 time in Web of Science Cited 2 time in Scopus

Kim, Dong-Yun; Kim, Jae Sik; Seo, Young-Seok; Park, Woo-Yoon; Kim, Byoung Hyuck; Hong, Eun-Hee; Kim, Ji Young; Cho, Seong-Jun; Rhee, Hak Young; Kim, Aryun; Kim, Keun You; Oh, Dae Jong; Chung, Weon Kuu

Issue Date
IOS Press
Journal of Alzheimer's Disease, Vol.95 No.3, pp.1263-1272
Background: Alzheimer's disease (AD), the most common cause of dementia, is a neurodegenerative disease resulting from extracellular and intracellular deposits of amyloid-beta (A beta) and neurofibrillary tangles in the brain. Although many clinical studies evaluating pharmacological approaches have been conducted, most have shown disappointing results; thus, innovative strategies other than drugs have been actively attempted. Objective: This study aims to explore low-dose radiation therapy (LDRT) for the treatment of patients with AD based on preclinical evidence, case reports, and a small pilot trial in humans. Methods: This study is a phase II, multicenter, prospective, single-blinded, randomized controlled trial that will evaluate the efficacy and safety of LDRT to the whole brain using a linear accelerator in patients with mild AD. Sixty participants will be randomly assigned to three groups: experimental I (24 cGy/6 fractions), experimental II (300 cGy/6 fractions), or sham RT group (0 cGy/6 fractions). During LDRT and follow-up visits after LDRT, possible adverse events will be assessed by the physician's interview and neurological examinations. Furthermore, the effectiveness of LDRT will be measured using neurocognitive function tests and imaging tools at 6 and 12 months after LDRT. We will also monitor the alterations in cytokines, A beta(42)/A beta(40) ratio, and tau levels in plasma. Our primary endpoint is the change in cognitive function test scores estimated by the Alzheimer's Disease Assessment Scale-Korea compared to baseline after 6 months of LDRT. Conclusions: This study is registered at [NCT05635968] and is currently recruiting patients. This study will provide evidence that LDRT is a new treatment strategy for AD.
Files in This Item:
There are no files associated with this item.
Appears in Collections:

Related Researcher

Kim, Byoung hyuck Image

Kim, Byoung hyuck김병혁
  • College of Medicine
  • Department of Medicine
Research Area 소화기암, 육종, 폐암


Item View & Download Count

  • mendeley

Items in S-Space are protected by copyright, with all rights reserved, unless otherwise indicated.