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

N/AUnknownNCT04203121

Kyung Hee University Hospital at Gangdong10 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Alzheimer Disease

Eligibility

Sex: ALLMin age: 50 YearsMax age: 95 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: 6 months after the first visit.

Secondary Outcomes

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%.

Time frame: 6 months after the first visit