Alzheimer DiseaseNCT04203121
The Safety and Scientific Validity of Low-dose Whole Brain Radiotherapy in Alzheimer's Disease.
A study testing low dose whole brain radiation to treat Alzheimer disease in people with Alzheimer Disease, run by Kyung Hee University Hospital at Gangdong at 1 site in South Korea.
Trial summary
Alzheimer's disease is the most frequent neurocognitive disorder associated with dementia, with a constantly increasing prevalence associated with an aging population. Amyloid deposition is considered as the first molecular event on the onset of Alzheimer's disease. Read more about this study
- Who is it for?
- Ages 50 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- low dose whole brain radiation to treat Alzheimer disease
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Apr 2019to 31 Jul 2020
- Phase
- Interventional
- 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 50 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of mild or moderate Alzheimer's disease.
- Amyloid PET scan positivity.
- Korean Mini-Mental State Examination score ≥10 and ≤24.
- Clinical dementia rating scale 0.5, 1 or 2.
- Ability to undergo neurocognitive assessment at baseline visit, alone or accomparined by a caregiver.
- Ability to understand the clinical trial and give an informed consent
Who cannot join
- previous therapeutic whole brain irradiation
- Evidence of seizure activity
- Evidence of active dermatological skin disease of the scalp.
- History of malignant tumors.
- Pregnant or breastfeeding.
- If the researcher determines that participation in this study is inadequate because of other findings that are considered clinically important.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Kyung Hee University Hospital at Gangdong
Seoul, 05278
weonkyu chung, Dr., 821024187393, wkchung@khnmc.or.kr
Mijoo Chung, Dr., mjwithu@khnmc.or.kr
About this study
Official title: The Safety and Scientific Validity of Low-dose Whole Brain Radiotherapy on Brain Amyloidosis During the Treatment of Mild or Moderate Alzheimer's Disease.
Alzheimer's disease is the most frequent neurocognitive disorder associated with dementia, with a constantly increasing prevalence associated with an aging population. Amyloid deposition is considered as the first molecular event on the onset of Alzheimer's disease. It has already been demonstrated that low-dose radiotherapy is capable of reducing Alzheimer's disease-associated amyloid-β plaques and improving cognitive function in an animal model. In human, low-dose radiotherapy has demonstrated effectiveness in reducing bronchial amyloidosis.
The present study aims to conduct research by including 10 patients with a diagnosis of mild or moderately severe Alzheimer's disease and with evidence of amyloid pathology. Furthermore, the aim is to demonstrate the effectiveness of low-dose radiotherapy in reducing amyloid deposits in the human brain using molecular imaging (Flutemetamol(18F) PET) along with treatment of the specific target.
Read the detailed description
The investigators decided to use fractionated whole brain radiation doses of 1.8 Gy x 5 and 1.8 Gy x 3. Subjects will be followed with neurocognitive testing at 6 months post radiotherapy.
subjects 1-5 - 9Gy in 5 daily fractions
subjects 6-10 - 5.4Gy in 3 daily fractions
- Conditions
- Alzheimer Disease
- Being tested
- low dose whole brain radiation to treat Alzheimer disease
- Keywords
- radiotherapy
- 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 radiation to treat Alzheimer diseaseRadiation
subjects 1-5 : 9Gy in 5 daily fractions
subjects 6-10 : 5.4Gy in 3 daily fractions
| Study group | Role | What they receive |
|---|---|---|
| arm1 | Experimental | An initial 5 patients will be enrolled in the first treatment scheme and will be followed for 6 months after completion of treatment to assess safety and any toxicity events associated with treatment.
subjects 1-5 : 9 Gy in 5 fractions of 1.8 Gy on 5 consecutive days Receives: Radiation: low dose whole brain radiation to treat Alzheimer disease |
| arm2 | Experimental | Subjects in this arm will be enrolled in the second treatment scheme and will be followed for 6 months after completion of treatment to assess safety and any toxicity events associated with treatment.
subjects 6-10 : 5.4 Gy in 3 fractions of 1.8 Gy on 3 consecutive days Receives: Radiation: low dose whole brain radiation to treat Alzheimer disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate low-dose whole brain radiotherapy in subjects with early Alzheimer's dementia using neurocognitive testing methods
verification of radiation therapy effect through GDS test
Measured: 6 months after the first visit.
Secondary outcomes (1)
change in brain amlyoid deposits
The change in SUV of the frontal, parietal, extramedullary, pre-wedge, and posterior fasciocutaneous flutemetamol (18F) PET is considered to be an effective response if the change in SUV is more than 5%.
Measured: 6 months after the first visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2019
- Study start1 Apr 2019
- Primary completion31 Jul 2020 (estimated)
- Study completion31 Jul 2020 (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
- arm 1 :subjects 1-5 - 9Gy in 5 daily fractions arm 2 :subjects 6-10 - 5.4Gy in 3 daily fractions
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kyung Hee University Hospital at Gangdong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04203121
- Sponsor's protocol ID
- KHNMC 2018-09-022-003
- Status last verified
- Sep 2019
- First submitted
- 21 Nov 2019
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Scientific Validity of Low-dose Whole Brain Radiotherapy on Brain Amyloidosis During the Treatment of Mild or Moderate Alzheimer's Disease.
- ClinicalTrials.gov ID
- NCT04203121
- Acronym / sponsor ID
- KHNMC 2018-09-022-003
- Conditions
- Alzheimer Disease
- Keywords
- radiotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Kyung Hee University Hospital at GangdongUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 31 Jul 2020 (estimated)
- Study completion
- 31 Jul 2020 (estimated)
- First posted
- 18 Dec 2019 (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.
Alzheimer's disease is the most frequent neurocognitive disorder associated with dementia, with a constantly increasing prevalence associated with an aging population. Amyloid deposition is considered as the first molecular event on the onset of Alzheimer's disease. It has already been demonstrated that low-dose radiotherapy is capable of reducing Alzheimer's disease-associated amyloid-β plaques and improving cognitive function in an animal model. In human, low-dose radiotherapy has demonstrated effectiveness in reducing bronchial amyloidosis.
The present study aims to conduct research by including 10 patients with a diagnosis of mild or moderately severe Alzheimer's disease and with evidence of amyloid pathology. Furthermore, the aim is to demonstrate the effectiveness of low-dose radiotherapy in reducing amyloid deposits in the human brain using molecular imaging (Flutemetamol(18F) PET) along with treatment of the specific target.
Detailed description
The investigators decided to use fractionated whole brain radiation doses of 1.8 Gy x 5 and 1.8 Gy x 3. Subjects will be followed with neurocognitive testing at 6 months post radiotherapy.
subjects 1-5 - 9Gy in 5 daily fractions
subjects 6-10 - 5.4Gy in 3 daily fractions
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- arm 1 :subjects 1-5 - 9Gy in 5 daily fractions arm 2 :subjects 6-10 - 5.4Gy in 3 daily fractions
| Arm | Type | Receives |
|---|---|---|
| arm1 | Experimental | Radiation: low dose whole brain radiation to treat Alzheimer diseaseAn initial 5 patients will be enrolled in the first treatment scheme and will be followed for 6 months after completion of treatment to assess safety and any toxicity events associated with treatment. subjects 1-5 : 9 Gy in 5 fractions of 1.8 Gy on 5 consecutive days |
| arm2 | Experimental | Radiation: low dose whole brain radiation to treat Alzheimer diseaseSubjects in this arm will be enrolled in the second treatment scheme and will be followed for 6 months after completion of treatment to assess safety and any toxicity events associated with treatment. subjects 6-10 : 5.4 Gy in 3 fractions of 1.8 Gy on 3 consecutive days |
Who may qualify
- Ages
- 50 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Clinical diagnosis of mild or moderate Alzheimer's disease.
- Amyloid PET scan positivity.
- Korean Mini-Mental State Examination score ≥10 and ≤24.
- Clinical dementia rating scale 0.5, 1 or 2.
- Ability to undergo neurocognitive assessment at baseline visit, alone or accomparined by a caregiver.
Key exclusion criteria (6 listed)
- previous therapeutic whole brain irradiation
- Evidence of seizure activity
- Evidence of active dermatological skin disease of the scalp.
- History of malignant tumors.
- Pregnant or breastfeeding.
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 |
|---|---|---|
| low dose whole brain radiation to treat Alzheimer diseasesubjects 1-5 : 9Gy in 5 daily fractions subjects 6-10 : 5.4Gy in 3 daily fractions | Radiation | arm1, arm2 |
Primary outcome
Evaluate low-dose whole brain radiotherapy in subjects with early Alzheimer's dementia using neurocognitive testing methods
Time frame: 6 months after the first visit.
verification of radiation therapy effect through GDS test
1 secondary outcome
change in brain amlyoid deposits
Time frame: 6 months after the first visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low dose whole brain radiation to treat Alzheimer disease 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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 20 Feb 2020. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact WeonKyu Chung, Dr. (821024187393, wkchung@khnmc.or.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate low-dose whole brain radiotherapy in subjects with early Alzheimer's dementia using neurocognitive testing methods (time frame: 6 months after the first visit.). 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 20 Feb 2020.