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

Kyung Hee University

Status: Unknown

Conditions: Alzheimer Disease

Treatments: Radiation: low dose whole brain radiation to treat Alzheimer disease

Study type: Interventional

Funder types: Other

Identifiers

NCT04203121

KHNMC 2018-09-022-003

Details and patient eligibility

About

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.

Full 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

Enrollment: 10 estimated patients

Sex: All

Ages: 50 to 95 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

arm1

Experimental group

Description:

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

Treatment:

Radiation: low dose whole brain radiation to treat Alzheimer disease

arm2

Experimental group

Description:

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

Treatment:

Radiation: low dose whole brain radiation to treat Alzheimer disease