NCT04203121

The Safety and Scientific Validity of Low-dose Whole Brain Radiotherapy in Alzheimer's Disease.

The Safety and Scientific Validity of Low-dose Whole Brain Radiotherapy on Brain Amyloidosis During the Treatment of Mild or Moderate Alzheimer's Disease.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Kyung Hee University Hospital at Gangdong · Academic / Other
• Sex: All
• Age: 50 Years – 95 Years
• Healthy volunteers: Accepted

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

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
RADIATION	low dose whole brain radiation to treat Alzheimer disease	subjects 1-5 : 9Gy in 5 daily fractions subjects 6-10 : 5.4Gy in 3 daily fractions

Timeline

• Start date: 2019-04-01
• Primary completion: 2020-07-31
• Completion: 2020-07-31
• First posted: 2019-12-18
• Last updated: 2020-02-20

Locations

1 site across 1 country: South Korea