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Alzheimer DiseasePhase 2LDRT-AD-02NCT05635968

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

A Phase 2 study testing Low-dose whole brain irradiation in people with Alzheimer Disease, run by Kyung Hee University Hospital at Gangdong at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 to 85 years
Conditions the study is for
Alzheimer Disease
What is being tested?
Low-dose whole brain irradiation
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
71 participants
Where
1 siteSouth Korea
Study dates
15 Jul 2022to 15 Apr 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)).
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Kyung Hee University Hospital at Gangdong

    Seoul, 05278

Other trials in South Korea

About this study

Official title: 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.

Read the 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.

Being tested
Low-dose whole brain irradiation
Keywords
radiation therapy, Low-dose whole brain irradiation
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Low-dose whole brain irradiationRadiation

    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 groups in NCT05635968
Study groupRoleWhat they receive
Low-dose whole brain irradiation group 1 (4cGy/day)ExperimentalLow-dose whole brain irradiation with general AD medication treatment (4cGy/day, 2times/1wk, total 24cGy, 6 times/3wks)
Receives: Radiation: Low-dose whole brain irradiation
Low-dose whole brain irradiation group 2 (50cGy/day)ExperimentalLow-dose whole brain irradiation with general AD medication treatment (50cGy/day, 2times/1wk, total 300cGy, 6 times/3wks)
Receives: Radiation: Low-dose whole brain irradiation
Sham RT groupSham comparatorSham RT wtih general AD medication treatment (0cGy/day, 2times/1wk, total 0cGy, 6 times/3wks)
Receives: Radiation: Low-dose whole brain irradiation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 months after completion of low-dose irradiation to whole brain

  2. saftey and efficacy

    1. Number of adverse events 6 months after baseline determined by the Radiation Therapy Oncology Group (RTOG) toxicity grading system.

    Measured: 6 months after completion of low-dose irradiation to whole brain

Secondary outcomes (5)

  1. 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.

    Measured: 6 months after completion of low-dose irradiation to whole brain

  2. 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.

    Measured: 6 months after completion of low-dose irradiation to whole brain

  3. 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.

    Measured: 6 months after completion of low-dose irradiation to whole brain

  4. 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.

    Measured: 6 months after completion of low-dose irradiation to whole brain

  5. 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.

    Measured: 6 months after completion of low-dose irradiation to whole brain

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2022
  2. Study start15 Jul 2022
  3. Primary completion26 Feb 2025
  4. Study completion15 Apr 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
71 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05635968
Sponsor's protocol ID
KHNMC 2022-03-030
Acronym
LDRT-AD-02
Status last verified
Aug 2025
First submitted
28 Oct 2022
Last updated
27 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 37638435

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Low-dose whole brain irradiation in people with Alzheimer Disease, run by Kyung Hee University Hospital at Gangdong at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

saftey and efficacy (time frame: 6 months after completion of low-dose irradiation to whole brain). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05635968, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2025.

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