The Clinical Trial of Low Dose Irradiation for Alzheimer's Disease

NCT ID: NCT05635968

Last Updated: 2025-08-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-15
• Study Completion Date: 2025-04-15

Brief Summary

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.

Detailed Description

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.

Conditions

Alzheimer Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Low-dose whole brain irradiation group 1 (4cGy/day)

Low-dose whole brain irradiation with general AD medication treatment (4cGy/day, 2times/1wk, total 24cGy, 6 times/3wks)

Group Type: EXPERIMENTAL

Low-dose whole brain irradiation

Intervention Type: RADIATION

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.

Low-dose whole brain irradiation group 2 (50cGy/day)

Low-dose whole brain irradiation with general AD medication treatment (50cGy/day, 2times/1wk, total 300cGy, 6 times/3wks)

Group Type: EXPERIMENTAL

Low-dose whole brain irradiation

Intervention Type: RADIATION

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.

Sham RT group

Sham RT wtih general AD medication treatment (0cGy/day, 2times/1wk, total 0cGy, 6 times/3wks)

Group Type: SHAM_COMPARATOR

Low-dose whole brain irradiation

Intervention Type: RADIATION

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.

Interventions

Low-dose whole brain irradiation

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.

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

All of the following criteria are satisfied for the subjects to be included in the study:

1. Aged between 60 and 85 years.

2. 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).

3. Stably maintaining the general AD drug treatment (donepezil, galantamine, rivastigmine, or memantine) for more than 3 months.

4. Amyloid accumulation in brain confirmed by Amyloid PET.

5. 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)).

6. Able to perform cognitive function tests and imaging tests.

7. Accompanied by a guardian who provides information on the subject's overall status, cognitive function, and functional changes.

8. Written informed consent was provided by the subject or the guardian to participate in this trial.

Exclusion Criteria

Subjects who fall under any of the following criteria are excluded from the study:

1. Previous history of radiation to the brain.

2. History of seizure within the previous 10 years of the screening time.

3. Skin disease on the scalp.

4. Previous history of malignancy.

5. Pregnancy or breastfeeding.

6. 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).

7. Clinically significant, unstable mental illness (i.e., uncontrolled depression, schizophrenia, and bipolar disorder) within the last 6 months.

9. 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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Korea Hydro&Nuclear Power Radiation Health Institute

UNKNOWN

Sponsor Role: collaborator

Chungbuk National University Hospital

OTHER

Sponsor Role: collaborator

SMG-SNU Boramae Medical Center

OTHER

Sponsor Role: collaborator

Kyung Hee University Hospital at Gangdong

OTHER

Sponsor Role: lead

Responsible Party

Weon Kuu Chung

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Weon-Kuu Chung, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Kyung Hee University Hospital at Gangdong

Locations

Kyung Hee University Hospital at Gangdong

Seoul, , South Korea

Countries

South Korea

References

Kim DY, Kim JS, Seo YS, Park WY, Kim BH, Hong EH, Kim JY, Cho SJ, Rhee HY, Kim A, Kim KY, Oh DJ, Chung WK. Evaluation of Efficacy and Safety Using Low Dose Radiation Therapy with Alzheimer's Disease: A Protocol for Multicenter Phase II Clinical Trial. J Alzheimers Dis. 2023;95(3):1263-1272. doi: 10.3233/JAD-230241.

Reference Type: DERIVED

PMID: 37638435 (View on PubMed)

Other Identifiers

KHNMC 2022-03-030

Identifier Type: -

Identifier Source: org_study_id