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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
71
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.
Kyung Hee University Hospital at Gangdong
Seoul, South Korea
saftey and efficacy
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.
Time frame: 6 months after completion of low-dose irradiation to whole brain
saftey and efficacy
2\) Number of adverse events 6 months after baseline determined by the Radiation Therapy Oncology Group (RTOG) toxicity grading system.
Time frame: 6 months after completion of low-dose irradiation to whole brain
Changes in cognitive function test score
If the cognitive function test such as Korean-Mini-Mental Status Examination (K-MMSE)(range 0-30, higher scrores mean a better outcome) showed an improvement of 5% or more after six months, it was evaluated as an effective response.
Time frame: 6 months after completion of low-dose irradiation to whole brain
Changes in cognitive function test score
If the cognitive function test such as Clinical Dementia Rating scale (CDR)(range 0-3, higher scrores mean a worse outcome) showed an improvement of 5% or more after six months, it was evaluated as an effective response.
Time frame: 6 months after completion of low-dose irradiation to whole brain
Changes in cognitive function test score
If the cognitive function test such as Caregiver Administered-Neuropsychiatric Inventory (CGA-NPI)(range 0-144, higher scrores mean a worse outcome) showed an improvement of 5% or more after six months, it was evaluated as an effective response.
Time frame: 6 months after completion of low-dose irradiation to whole brain
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Changes in cognitive function test score
If the cognitive function test such as Korean Intstrumental Activities of Daily Living (K-iADL)(range 10-33, higher scrores mean a worse outcome) showed an improvement of 5% or more after six months, it was evaluated as an effective response.
Time frame: 6 months after completion of low-dose irradiation to whole brain
Changes in the standardized uptake value ratio (SUVR)
Changes in the standardized uptake value ratio (SUVR) of the amyloid PET in the frontal, parietal, lateral temporal, anterior wedge lobe, and the posterior gyrus are evaluated. It was considered as an effective response if the change of SUVR shows an improvement of 5% or more 6 months after the completion of LDIR.
Time frame: 6 months after completion of low-dose irradiation to whole brain