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

Alzheimer Disease Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04203121
• Other study ID #: KHNMC 2018-09-022-003
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: July 31, 2020

Study information

• Verified date: September 2019
• Source: Kyung Hee University Hospital at Gangdong
• Contact: WeonKyu Chung, Dr.
• Phone: 821024187393
• Email: wkchung[@]khnmc.or.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: July 31, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 95 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Kyung Hee University Hospital at Gangdong	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Kyung Hee University Hospital at Gangdong

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 months after the first visit.
Secondary	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%.	6 months after the first visit