Clinical trial NCT04203121: The Safety and Scientific Validity of Low-dose Whole Brain Radiotherapy in Alzheimer's Disease.
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alzheimer Disease
Keywords: radiotherapy
Lead sponsor: Kyung Hee University Hospital at Gangdong
Sponsor class: OTHER
First posted: 2019-12-18
Enrollment: 10
Sex: ALL
Minimum age (years): 50
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: arm 1 :subjects 1-5 - 9Gy in 5 daily fractions

arm 2 :subjects 6-10 - 5.4Gy in 3 daily fractions
Primary purpose: TREATMENT

Brief 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. 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

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Evaluate low-dose whole brain radiotherapy in subjects with early Alzheimer's dementia using neurocognitive testing methods
timeFrame: 6 months after the first visit.
Secondary outcomes:
measure: change in brain amlyoid deposits
timeFrame: 6 months after the first visit
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital at Gangdong
Study officials:
References: