The Clinical Trial of Low Dose Irradiation for Alzheimer's Disease (LDRT-AD-02)

August 20, 2025 updated by: Weon Kuu Chung, Kyung Hee University Hospital at Gangdong

The Multicenter Phase II Clinical Trial for Evaluation of Safety and Efficacy Using Low Dose Irradiation With Alzheimer's Disease

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
71

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • South Korea
      • Seoul, South Korea, 05278
        • Kyung Hee University Hospital at Gangdong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

56 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.
  8. 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.
  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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)
Radiation: 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.
Experimental: 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)
Radiation: 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.
Sham Comparator: Sham RT group
Sham RT wtih general AD medication treatment (0cGy/day, 2times/1wk, total 0cGy, 6 times/3wks)
Radiation: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
saftey and efficacy
Time Frame: 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.
6 months after completion of low-dose irradiation to whole brain
saftey and efficacy
Time Frame: 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.
6 months after completion of low-dose irradiation to whole brain

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in cognitive function test score
Time Frame: 6 months after completion of low-dose irradiation to whole brain
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.
6 months after completion of low-dose irradiation to whole brain
Changes in cognitive function test score
Time Frame: 6 months after completion of low-dose irradiation to whole brain
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.
6 months after completion of low-dose irradiation to whole brain
Changes in cognitive function test score
Time Frame: 6 months after completion of low-dose irradiation to whole brain
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.
6 months after completion of low-dose irradiation to whole brain
Changes in cognitive function test score
Time Frame: 6 months after completion of low-dose irradiation to whole brain
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.
6 months after completion of low-dose irradiation to whole brain
Changes in the standardized uptake value ratio (SUVR)
Time Frame: 6 months after completion of low-dose irradiation to whole brain
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.
6 months after completion of low-dose irradiation to whole brain

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kyung Hee University Hospital at Gangdong

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
SMG-SNU Boramae Medical Center
Chungbuk National University Hospital
Korea Hydro&Nuclear Power Radiation Health Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Weon-Kuu Chung, MD, PhD, Kyung Hee University Hospital at Gangdong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 15, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 26, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 15, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 28, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 22, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 2, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 27, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KHNMC 2022-03-030

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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