NCT05635968

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P25-P50 for phase_2 alzheimer-disease

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 28, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 2, 2022

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 26, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2025

Completed
Last Updated

August 27, 2025

Status Verified

August 1, 2025

Enrollment Period

2.6 years

First QC Date

October 28, 2022

Last Update Submit

August 20, 2025

Conditions

Alzheimer Disease

Keywords

radiation therapyLow-dose whole brain irradiation

Outcome Measures

Primary Outcomes (2)

  • 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.

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

  • saftey and efficacy

    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 Outcomes (5)

  • Changes in cognitive function test score

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

  • Changes in cognitive function test score

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

  • Changes in cognitive function test score

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

  • Changes in cognitive function test score

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

  • Changes in the standardized uptake value ratio (SUVR)

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

Study Arms (3)

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

Sham RT group

SHAM COMPARATOR

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

Radiation: Low-dose whole brain irradiation

Interventions

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.

Low-dose whole brain irradiation group 1 (4cGy/day)Low-dose whole brain irradiation group 2 (50cGy/day)Sham RT group

Eligibility Criteria

Age60 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)).
  • 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.

You may not qualify if:

  • 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.
  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kyung Hee University Hospital at Gangdong

Seoul, 05278, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 37638435DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Weon-Kuu Chung, MD, PhD

    Kyung Hee University Hospital at Gangdong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
single blinded (subject)
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 28, 2022

First Posted

December 2, 2022

Study Start

July 15, 2022

Primary Completion

February 26, 2025

Study Completion

April 15, 2025

Last Updated

August 27, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)