Low-dose irradiation treatment for Alzheimer's disease

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

This study is testing if low-dose radiation treatment can help improve symptoms in older adults with Alzheimer's disease.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 60 Years to 85 Years
• Sex: All
• Sponsor: Kyung Hee University Hospital at Gangdong (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Seoul)
• Trial ID: NCT05635968 on ClinicalTrials.gov

What this trial studies

This phase II, multicenter, prospective, randomized controlled trial evaluates the safety and efficacy of low-dose whole brain irradiation (LDIR) in patients with Alzheimer's disease. Eligible participants aged 60 to 85 will undergo screening tests, cognitive assessments, and imaging to confirm their condition before being randomized into experimental and control groups. The experimental groups will receive varying doses of irradiation over three weeks, while the control group will receive sham radiation. Follow-up assessments will occur at 1, 6, and 12 months post-treatment to evaluate outcomes.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 60 to 85 diagnosed with mild Alzheimer's disease and stable on AD medications.

Not a fit: Patients with severe Alzheimer's disease or those unable to undergo cognitive and imaging tests may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a novel therapeutic option for patients with Alzheimer's disease, potentially improving cognitive function and quality of life.

How similar studies have performed: While low-dose irradiation has been explored in other contexts, this specific approach for Alzheimer's disease is novel and has not been extensively tested.

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.
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.

Where this trial is running

Seoul

• Kyung Hee University Hospital at Gangdong — Seoul, Korea, Republic of (Recruiting)

Study contacts

• Principal investigator: Weon-Kuu Chung, MD, PhD — Kyung Hee University Hospital at Gangdong
• Study coordinator: Weon-Kuu Chung, MD, PhD

Conditions Alzheimer Disease; radiation therapy; Low-dose whole brain irradiation