The Multicenter Phase II Clinical Trial for Evaluation of Safety and Efficacy Using Low Dose Irradiation With Alzheimer's Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 2
- 主要终点
- saftey and efficacy
研究概览
简要总结
This is a phase II, multicenter, prospective, randomized controlled trial to treat patients with Alzheimer's disease (AD) using low-dose irradiation (LDIR). This study aims to evaluate the safety and efficacy of LDIR to whole brain in patients with AD and to determine the potentially applicable radiation dose.
详细描述
Screening tests, cognitive function tests, brain MRI, and amyloid PET are performed on subjects who voluntarily consent in writing to participate in the trial to determine whether they meet the inclusion/exclusion criteria. Randomization is assigned to eligible subjects. The experimental groups are irradiated six times for 3 weeks according to the radiation dose determined for each group, and the control group is irradiated with sham radiation. The patients assigned to the experimental group receive whole brain irradiation with 6 MV energy using a linear accelerator. In the experimental group (1), 20 patients receive 4cGy x 6 times, a total of 24 cGy of irradiation. In the experimental group (2), 20 patients receive 50 cGy x 6 times, a total of 300 cGy of irradiation. All experimental groups and control group visit the hospital about 1, 6, and 12 months after irradiation to evaluate efficacy and safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
盲法说明
single blinded (subject)
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All of the following criteria are satisfied for the subjects to be included in the study:
- •Aged between 60 and 85 years.
- •Diagnosed with probable Alzheimer's disease (AD) dementia based on the new diagnostic criteria for Alzheimer's disease outlined by the National Institute on Aging and Alzheimer's Association (NIA-AA).
- •Stably maintaining the general AD drug treatment (donepezil, galantamine, rivastigmine, or memantine) for more than 3 months.
- •Amyloid accumulation in brain confirmed by Amyloid PET.
- •Mild AD (score range of 13 to 24 on the Korean Mini-Mental State Examination (K-MMSE) or 0.5 or 1 on the Clinical Dementia Rating scale (CDR)).
- •Able to perform cognitive function tests and imaging tests.
- •Accompanied by a guardian who provides information on the subject's overall status, cognitive function, and functional changes.
- •Written informed consent was provided by the subject or the guardian to participate in this trial.
排除标准
- •Subjects who fall under any of the following criteria are excluded from the study:
- •Previous history of radiation to the brain.
- •History of seizure within the previous 10 years of the screening time.
- •Skin disease on the scalp.
- •Previous history of malignancy.
- •Pregnancy or breastfeeding.
- •Subjects with cognitive decline associated with drugs or neurological / neurodegenerative conditions, not AD (i.e., drug abuse, vitamin B12 deficiency, thyroid dysfunction, stroke or other cerebrovascular conditions, Lewy body dementia, frontotemporal dementia, and head trauma).
- •Clinically significant, unstable mental illness (i.e., uncontrolled depression, schizophrenia, and bipolar disorder) within the last 6 months.
- •Subjects whose brain MRI confirms evidence of: acute or subacute hemorrhage, prior macro hemorrhage (defined as >1 cm in diameter, T2 sequence) or prior subarachnoid hemorrhage unless it can be documented that the finding is not due to an underlying structural or vascular abnormality, more than 4 microhemorrhages, cortical infarct (defined as >1.5 cm in diameter, irrespective of anatomic location), >1 lacunar infarct (defined as >1.5 cm in diameter), superficial siderosis, and history of diffuse white matter disease as defined by a score of 3 on the age-related white matter changes scale. Any finding that, in the opinion of the investigator, might be a contributing cause of the subject's dementia, or pose a risk to the subject, or might prevent a satisfactory MRI assessment for safety monitoring are also included in the exclusion criteria.
- •Those who have other findings that are considered clinically important, and those who are judged by the researcher to be inappropriate for participation in this study.
结局指标
主要结局
saftey and efficacy
时间窗: 6 months after completion of low-dose irradiation to whole brain
1\) Changes in cognitive function test score compared to baseline after six months are estimated using Alzheimer's disease assessment scale-Korea (ADAS-K) (range 0-70, higher scrores mean a worse outcome). The amount of change is evaluated as a valid response if it shows an improvement of 5% or more compared to the baseline score.
saftey and efficacy
时间窗: 6 months after completion of low-dose irradiation to whole brain
2\) Number of adverse events 6 months after baseline determined by the Radiation Therapy Oncology Group (RTOG) toxicity grading system.
次要结局
- Changes in the standardized uptake value ratio (SUVR)(6 months after completion of low-dose irradiation to whole brain)
- Changes in cognitive function test score(6 months after completion of low-dose irradiation to whole brain)
研究者
Weon Kuu Chung
Professor
Kyung Hee University Hospital at Gangdong