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

NCT04203121 | Unknown

• 1 other identifier: KHNMC 2018-09-022-003
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease

Keywords

radiotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• change in brain amlyoid deposits

  6 months after the first visit

Study Arms (2)

arm1

EXPERIMENTAL

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

Radiation: low dose whole brain radiation to treat Alzheimer disease

arm2

EXPERIMENTAL

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

Radiation: low dose whole brain radiation to treat Alzheimer disease

Interventions

low dose whole brain radiation to treat Alzheimer disease RADIATION

subjects 1-5 : 9Gy in 5 daily fractions subjects 6-10 : 5.4Gy in 3 daily fractions

arm1; arm2

Eligibility Criteria

• Age: 50 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kyung Hee University Hospital at Gangdong: lead

Study Sites (1)

Kyung Hee University Hospital at Gangdong

Seoul, 05278, South Korea

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

WeonKyu Chung, Dr.

CONTACT

821024187393; wkchung@khnmc.or.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: arm 1 :subjects 1-5 - 9Gy in 5 daily fractions arm 2 :subjects 6-10 - 5.4Gy in 3 daily fractions

Study Record Dates

• First Submitted: November 21, 2019
• First Posted: December 18, 2019
• Study Start: April 1, 2019
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2020
• Last Updated: February 20, 2020

Record last verified: 2019-09

Locations

KR (1)