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

Author:

Kim Dong-Yun1,Kim Jae Sik2,Seo Young-Seok3,Park Woo-Yoon3,Kim Byoung Hyuck4,Hong Eun-Hee5,Kim Ji Young5,Cho Seong-Jun5,Rhee Hak Young6,Kim Aryun7,Kim Keun You8,Oh Dae Jong9,Chung Weon Kuu1

Affiliation:

1. Department of Radiation Oncology, Kyunghee University Hospital at Gangdong, Seoul, Korea

2. Department of Radiation Oncology, Soonchunhyang University Seoul Hospital, Seoul, Korea

3. Department of Radiation Oncology, Chungbuk National University Hospital, Cheongju, Korea

4. Department of Radiation Oncology, Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul, Korea

5. Radiation Health Research Institute, Korea Hydro & Nuclear Power Co Ltd., Seoul, Korea

6. Department of Neurology, Kyunghee University Hospital at Gangdong, Seoul, Korea

7. Department of Neurology, Chungbuk National University Hospital, Cheongju, Korea

8. Department of Psychiatry, Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul, Korea

9. Workplace Mental Health Institute, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea

Abstract

Background: Alzheimer’s disease (AD), the most common cause of dementia, is a neurodegenerative disease resulting from extracellular and intracellular deposits of amyloid-β (Aβ) 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, Aβ42/Aβ40 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 ClinicalTrials.gov [NCT05635968] and is currently recruiting patients. This study will provide evidence that LDRT is a new treatment strategy for AD.

Publisher

IOS Press

Subject

Psychiatry and Mental health,Geriatrics and Gerontology,Clinical Psychology,General Medicine,General Neuroscience

Reference30 articles.

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Cited by 2 articles. 订阅此论文施引文献 订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献

1. Alzheimer's disease and low-dose radiation therapy: A new hope;Radiation Medicine and Protection;2024-03

2. In Reply to Halperin;International Journal of Radiation Oncology*Biology*Physics;2024-02

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