Alzheimer DiseaseLDRT-AD-03NCT07863011
Exploratory Study of Low-Dose Whole-Brain Radiation Therapy With HeLaXON 1X in Patients With Mild Alzheimer's Disease Dementia
A study testing HeLaXON 1X Low-Dose Radiation Therapy in people with Alzheimer Disease, run by ReadyCure Inc. at 1 site in South Korea.
Trial summary
This randomized, sham-controlled, exploratory clinical trial will evaluate the efficacy and safety of HeLaXON, an investigational low-dose radiation therapy device, in patients with mild Alzheimer's disease dementia. 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?
- HeLaXON 1X Low-Dose Radiation Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 26 Oct 2026to 30 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Male or female participants aged 60 to 85 years, inclusive.
- Mild dementia (Stage 4) according to the NIA-AA (New Diagnostic Criteria for Alzheimer's Disease) criteria.
- At screening, participants must meet all of the following criteria:
- K-MMSE-2 score of 20 to 26, inclusive.
- CDR Global Score of 1, or CDR Global Score of 0.5 or 1 with a CDR-SB score of 4.5 to 9.0, inclusive.
- Memory Box Score of at least 0.5.
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- If receiving a cholinesterase inhibitor (donepezil, galantamine, or rivastigmine) for symptomatic treatment, the participant must have been maintained on a stable dose for at least 12 weeks before the screening visit.
- Positive cerebral amyloid accumulation confirmed by amyloid PET.
- Able to undergo the cognitive assessments and imaging examinations required by the study.
- Has a caregiver who can provide information regarding the participant's overall condition and changes in cognitive and functional status.
- Written informed consent for study participation must be obtained from a legally authorized representative. If, based on the investigator's assessment of decision-making capacity, the participant is considered able to understand the purpose and procedures of the study and voluntarily express his or her wishes, written informed consent will also be obtained from the participant.
Who cannot join
- 1. History of prior radiation therapy to the brain. 2. History of seizure within 10 years before the screening date. 4. Presence of a scalp skin disorder. 5. History of hypersensitivity to Vizamyl™ (flutemetamol F 18 injection) or any of its major excipients, including polysorbate 80.
- Contraindication to MRI, including but not limited to a pacemaker, metallic implant, or severe claustrophobia that prevents MRI examination.
- 6. Diagnosis of a malignant tumor within 5 years before the screening visit or currently receiving treatment for a malignancy.
- 7. Pregnant or breastfeeding. 8. Previous treatment with an anti-amyloid monoclonal antibody without an interval of at least 5 half-lives before the screening visit.
- 9. Cognitive impairment attributable to a condition other than Alzheimer's disease, including drug-related causes or other neurological or neurodegenerative conditions such as substance abuse, vitamin B12 deficiency, thyroid dysfunction, stroke or other cerebrovascular disease, Lewy body dementia, frontotemporal dementia, or traumatic brain injury.
- 10. Clinically significant unstable psychiatric disorder, including uncontrolled depression, schizophrenia, or bipolar disorder, diagnosed within 6 months before screening.
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- 11. Any of the following findings on brain MRI:
- Acute or subacute hemorrhage.
- Prior macrohemorrhage greater than 1 cm in diameter on T2-weighted imaging, or prior subarachnoid hemorrhage, unless it can be documented that the finding is not due to an underlying structural or vascular abnormality and does not suggest a risk of recurrent hemorrhage.
- More than 4 microhemorrhages.
- Cortical infarct greater than 1.5 cm in diameter, irrespective of anatomical location.
- More than 1 lacunar infarct greater than 1.5 cm in diameter.
- Superficial siderosis.
- Diffuse white matter disease defined as a score of 3 on the age-related white matter changes scale.
- Any MRI finding that, in the opinion of the investigator, may contribute to the participant's dementia, pose a risk to the participant, or prevent satisfactory MRI assessment for safety monitoring.
- 12. Participation in another interventional clinical trial at screening with receipt of an investigational drug or application of an investigational medical device.
- 13. Any other clinically significant finding that, in the investigator's judgment, makes the participant unsuitable for study participation.
- 14. Unwilling or unable to use at least one medically acceptable method of contraception throughout the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Soonchunhyang University Cheonan Hospital
Cheonan, Chungcheongnam-do, 31151
InYoung Jo, PhD, +82-41-570-3550, inyoung.jo@schmc.ac.kr
About this study
Official title: A Prospective, Single-Center, Randomized, Subject-Assessor Double-Blind, Sham-Controlled, Exploratory Clinical Trial to Evaluate the Pre- and Post-Treatment Changes of HeLaXON, a Low-Dose Radiation Therapy Device, in Patients With Mild AD Dementia
This randomized, sham-controlled, exploratory clinical trial will evaluate the efficacy and safety of HeLaXON, an investigational low-dose radiation therapy device, in patients with mild Alzheimer's disease dementia. A total of 30 participants will be randomly assigned in a 1:1 ratio to receive either low-dose whole-brain radiation therapy or a sham procedure using the same device. Participants in the treatment group will receive 0.04 Gy per session twice weekly for 3 weeks, for a total of 6 sessions and a cumulative dose of 0.24 Gy. Participants in the sham group will undergo the same device procedures without radiation delivery. Participants and outcome assessors will remain blinded to treatment assignment. Changes in cognitive function, dementia severity, daily functioning, and amyloid burden will be evaluated at 6 and 12 months after treatment. Safety will be assessed throughout the study. Exploratory blood biomarkers, including plasma Aβ42/40 ratio, p-tau217, and Aβ oligomer, will also be evaluated.
Read the detailed description
This is a prospective, single-center, randomized, subject-assessor double-blind, sham-controlled, exploratory clinical trial designed to evaluate changes following treatment with HeLaXON in patients with mild Alzheimer's disease dementia.
Thirty eligible participants will be randomly assigned in a 1:1 ratio to an experimental group or a sham-control group. Participants assigned to the experimental group will receive low-dose whole-brain radiation therapy using HeLaXON 1X at a dose of 0.04 Gy per session, twice weekly for 3 weeks, for a total of 6 treatment sessions and a cumulative dose of 0.24 Gy. Participants assigned to the sham-control group will undergo the same positioning, head immobilization, device operation, sound, and lighting procedures, but no radiation will be delivered.
Efficacy assessments include CDR-SB, ADAS-K-Cog-13, K-MMSE-2, K-iADL, and amyloid burden quantified using the Centiloid scale. Changes from baseline will be assessed at 6 and 12 months. Safety assessments include adverse events, vital signs, physical examinations, laboratory tests, neurological examinations, and brain MRI. Exploratory plasma biomarkers including Aβ42/40 ratio, p-tau217, and Aβ oligomer will be assessed at baseline and 12 months.
- Conditions
- Alzheimer Disease
- Being tested
- HeLaXON 1X Low-Dose Radiation Therapy, Sham HeLaXON 1X Procedure
- Keywords
- Mild Alzheimer's Disease Dementia, Low-Dose Radiation Therapy, Whole-Brain Radiation Therapy, HeLaXON, HeLaXON 1X, Amyloid PET, Brain MRI, K-MMSE 2, K-iADL, CDR-sb, Neuroinflammation
- Medical subject headings
- Alzheimer Disease, Neuroinflammatory Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HeLaXON 1X Low-Dose Radiation TherapyDevice
Low-dose whole-brain X-ray radiation will be delivered using the HeLaXON 1X device at 0.04 Gy per session, twice weekly for 3 weeks. Participants will receive a total of 6 sessions, corresponding to a cumulative radiation dose of 0.24 Gy.
Sham HeLaXON 1X ProcedureDevice
The HeLaXON 1X device will be used with the same participant positioning, head and neck immobilization, device operation, sound, and lighting procedures as the experimental intervention; however, no radiation will be delivered. The total radiation dose will be 0.00 Gy.
| Study group | Role | What they receive |
|---|---|---|
| HeLaXON 1X Low-Dose Whole-Brain Radiation Therapy | Experimental | Participants will receive low-dose whole-brain radiation therapy using HeLaXON 1X at a dose of 0.04 Gy per session, twice weekly for 3 weeks, for a total of 6 sessions and a cumulative dose of 0.24 Gy. Receives: Device: HeLaXON 1X Low-Dose Radiation Therapy |
| Sham HeLaXON 1X Procedure | Sham comparator | Participants will undergo the same HeLaXON 1X procedures as the experimental group, including treatment positioning, head and neck immobilization, device operation, sound, and lighting, but no radiation will be delivered (0.00 Gy). Receives: Device: Sham HeLaXON 1X Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) Score
Change in ADAS-K-Cog-13 score from baseline will be evaluated at 6 and 12 months. The 13-item cognitive subscale evaluates multiple cognitive domains relevant to Alzheimer's disease. Lower scores indicate better preserved cognitive function.
Measured: Baseline to 6 months and 12 months after the intervention
Change From Baseline in Alzheimer's Disease Assessment Scale-Korea-Cognitive Subscale-13 (ADAS-K-Cog-13) Score
Change in ADAS-K-Cog-13 score from baseline will be evaluated at 6 and 12 months. The 13-item cognitive subscale evaluates multiple cognitive domains relevant to Alzheimer's disease. Lower scores indicate better preserved cognitive function.
Measured: Baseline to 6 months and 12 months after the intervention
Change From Baseline in Korean Mini-Mental Status Examination-2 (K-MMSE-2) Score
Change in K-MMSE-2 score from baseline will be evaluated at 6 and 12 months. The K-MMSE-2 is used to assess global cognitive function and changes in cognitive status over time.
Measured: Change in K-MMSE-2 score from baseline will be evaluated at 6 and 12 months. The K-MMSE-2 is used to assess global cognitive function and changes in cognitive status over time.
Change From Baseline in Korean Instrumental Activities of Daily Living (K-iADL) Score
Change in K-iADL score from baseline will be evaluated at 6 and 12 months. The K-iADL assesses the participant's ability to perform instrumental activities required for daily living.
Measured: Baseline to 6 months and 12 months after the intervention
Change From Baseline in Amyloid Burden Measured Using the Centiloid Scale
Change in cerebral amyloid burden from baseline will be assessed at 6 and 12 months. Amyloid PET images will be analyzed to obtain standardized uptake value ratios (SUVRs), which will be converted to the standardized Centiloid scale.
Measured: Change From Baseline in Amyloid Burden Measured Using the Centiloid Scale
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study start26 Oct 2026 (estimated)
- Primary completion31 Mar 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in a 1:1 ratio to either a low-dose whole-brain radiation therapy group or a sham-control group and will be followed in parallel.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ReadyCure Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07863011
- Sponsor's protocol ID
- HeLaXON-1X-P3
- Acronym
- LDRT-AD-03
- Status last verified
- Sep 2026
- First submitted
- 2 Oct 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-Center, Randomized, Subject-Assessor Double-Blind, Sham-Controlled, Exploratory Clinical Trial to Evaluate the Pre- and Post-Treatment Changes of HeLaXON, a Low-Dose Radiation Therapy Device, in Patients With Mild AD Dementia
- ClinicalTrials.gov ID
- NCT07863011
- Acronym / sponsor ID
- LDRT-AD-03 / HeLaXON-1X-P3
- Conditions
- Alzheimer Disease
- Keywords
- Mild Alzheimer's Disease Dementia, Low-Dose Radiation Therapy, Whole-Brain Radiation Therapy, HeLaXON, HeLaXON 1X, Amyloid PET, Brain MRI, K-MMSE 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- ReadyCure Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Oct 2026 (estimated)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 7 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized, sham-controlled, exploratory clinical trial will evaluate the efficacy and safety of HeLaXON, an investigational low-dose radiation therapy device, in patients with mild Alzheimer's disease dementia. A total of 30 participants will be randomly assigned in a 1:1 ratio to receive either low-dose whole-brain radiation therapy or a sham procedure using the same device. Participants in the treatment group will receive 0.04 Gy per session twice weekly for 3 weeks, for a total of 6 sessions and a cumulative dose of 0.24 Gy. Participants in the sham group will undergo the same device procedures without radiation delivery. Participants and outcome assessors will remain blinded to treatment assignment. Changes in cognitive function, dementia severity, daily functioning, and amyloid burden will be evaluated at 6 and 12 months after treatment. Safety will be assessed throughout the study. Exploratory blood biomarkers, including plasma Aβ42/40 ratio, p-tau217, and Aβ oligomer, will also be evaluated.
Detailed description
This is a prospective, single-center, randomized, subject-assessor double-blind, sham-controlled, exploratory clinical trial designed to evaluate changes following treatment with HeLaXON in patients with mild Alzheimer's disease dementia.
Thirty eligible participants will be randomly assigned in a 1:1 ratio to an experimental group or a sham-control group. Participants assigned to the experimental group will receive low-dose whole-brain radiation therapy using HeLaXON 1X at a dose of 0.04 Gy per session, twice weekly for 3 weeks, for a total of 6 treatment sessions and a cumulative dose of 0.24 Gy. Participants assigned to the sham-control group will undergo the same positioning, head immobilization, device operation, sound, and lighting procedures, but no radiation will be delivered.
Efficacy assessments include CDR-SB, ADAS-K-Cog-13, K-MMSE-2, K-iADL, and amyloid burden quantified using the Centiloid scale. Changes from baseline will be assessed at 6 and 12 months. Safety assessments include adverse events, vital signs, physical examinations, laboratory tests, neurological examinations, and brain MRI. Exploratory plasma biomarkers including Aβ42/40 ratio, p-tau217, and Aβ oligomer will be assessed at baseline and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to either a low-dose whole-brain radiation therapy group or a sham-control group and will be followed in parallel.
| Arm | Type | Receives |
|---|---|---|
| HeLaXON 1X Low-Dose Whole-Brain Radiation Therapy | Experimental | Device: HeLaXON 1X Low-Dose Radiation TherapyParticipants will receive low-dose whole-brain radiation therapy using HeLaXON 1X at a dose of 0.04 Gy per session, twice weekly for 3 weeks, for a total of 6 sessions and a cumulative dose of 0.24 Gy. |
| Sham HeLaXON 1X Procedure | Sham comparator | Device: Sham HeLaXON 1X ProcedureParticipants will undergo the same HeLaXON 1X procedures as the experimental group, including treatment positioning, head and neck immobilization, device operation, sound, and lighting, but no radiation will be delivered (0.00 Gy). |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female participants aged 60 to 85 years, inclusive.
- Mild dementia (Stage 4) according to the NIA-AA (New Diagnostic Criteria for Alzheimer's Disease) criteria.
- At screening, participants must meet all of the following criteria:
- If receiving a cholinesterase inhibitor (donepezil, galantamine, or rivastigmine) for symptomatic treatment, the participant must have been maintained on a stable dose for at least 12 weeks before the screening visit.
- Positive cerebral amyloid accumulation confirmed by amyloid PET.
Key exclusion criteria (18 listed)
- 1. History of prior radiation therapy to the brain. 2. History of seizure within 10 years before the screening date. 4. Presence of a scalp skin disorder. 5. History of hypersensitivity to Vizamyl™ (flutemetamol F 18 injection) or any of its major excipients, including polysorbate 80.
- Contraindication to MRI, including but not limited to a pacemaker, metallic implant, or severe claustrophobia that prevents MRI examination.
- 6. Diagnosis of a malignant tumor within 5 years before the screening visit or currently receiving treatment for a malignancy.
- 7. Pregnant or breastfeeding. 8. Previous treatment with an anti-amyloid monoclonal antibody without an interval of at least 5 half-lives before the screening visit.
- 9. Cognitive impairment attributable to a condition other than Alzheimer's disease, including drug-related causes or other neurological or neurodegenerative conditions such as substance abuse, vitamin B12 deficiency, thyroid dysfunction, stroke or other cerebrovascular disease, Lewy body dementia, frontotemporal dementia, or traumatic brain injury.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HeLaXON 1X Low-Dose Radiation TherapyLow-dose whole-brain X-ray radiation will be delivered using the HeLaXON 1X device at 0.04 Gy per session, twice weekly for 3 weeks. Participants will receive a total of 6 sessions, corresponding to a cumulative radiation dose of 0.24 Gy. | Device | HeLaXON 1X Low-Dose Whole-Brain Radiation Therapy |
| Sham HeLaXON 1X ProcedureThe HeLaXON 1X device will be used with the same participant positioning, head and neck immobilization, device operation, sound, and lighting procedures as the experimental intervention; however, no radiation will be delivered. The total radiation dose will be 0.00 Gy. | Device | Sham HeLaXON 1X Procedure |
Primary outcome
Change From Baseline in Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) Score
Time frame: Baseline to 6 months and 12 months after the intervention
Change in ADAS-K-Cog-13 score from baseline will be evaluated at 6 and 12 months. The 13-item cognitive subscale evaluates multiple cognitive domains relevant to Alzheimer's disease. Lower scores indicate better preserved cognitive function.
Change From Baseline in Alzheimer's Disease Assessment Scale-Korea-Cognitive Subscale-13 (ADAS-K-Cog-13) Score
Time frame: Baseline to 6 months and 12 months after the intervention
Change in ADAS-K-Cog-13 score from baseline will be evaluated at 6 and 12 months. The 13-item cognitive subscale evaluates multiple cognitive domains relevant to Alzheimer's disease. Lower scores indicate better preserved cognitive function.
Change From Baseline in Korean Mini-Mental Status Examination-2 (K-MMSE-2) Score
Time frame: Change in K-MMSE-2 score from baseline will be evaluated at 6 and 12 months. The K-MMSE-2 is used to assess global cognitive function and changes in cognitive status over time.
Change in K-MMSE-2 score from baseline will be evaluated at 6 and 12 months. The K-MMSE-2 is used to assess global cognitive function and changes in cognitive status over time.
Change From Baseline in Korean Instrumental Activities of Daily Living (K-iADL) Score
Time frame: Baseline to 6 months and 12 months after the intervention
Change in K-iADL score from baseline will be evaluated at 6 and 12 months. The K-iADL assesses the participant's ability to perform instrumental activities required for daily living.
Change From Baseline in Amyloid Burden Measured Using the Centiloid Scale
Time frame: Change From Baseline in Amyloid Burden Measured Using the Centiloid Scale
Change in cerebral amyloid burden from baseline will be assessed at 6 and 12 months. Amyloid PET images will be analyzed to obtain standardized uptake value ratios (SUVRs), which will be converted to the standardized Centiloid scale.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HeLaXON 1X Low-Dose Radiation Therapy in people with Alzheimer Disease, run by ReadyCure Inc. 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 11 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 7 Oct 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact SangHui BANG, Bachelor's degree (+82-2-959-2021, shbang2364@ready-cure.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) Score (time frame: Baseline to 6 months and 12 months after the intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Oct 2026.