Clinical investigators from the Beaumont Research Institute in Royal Oak, Michigan suspects low-dose radiation may represent a promising treatment for Alzheimer’s disease. Presently seeking participants, this study will assess the use of low dose fractionalized whole brain irradiation in those patients who have been diagnosed with Alzheimer’s disease based on criteria from the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer’s Disease and Related Disorders Association (NINCDS-ADRDA) criteria.
Context: Preclinical Research
The Beaumont Research Institute team bases their study on preclinical research; this specific approach was found to be effective at reducing plaques accumulating in the brain, reports Specialty Medical Dialogues. The plaque associated with Alzheimer’s actually is a protein called beta-amyloid. As it accumulates in the brain, researchers believe, this evidences the emergence of cognitive impairment—which ultimately leads to the neurodegenerative disease.
Beaumont on a Radiation Mission
For several years now, Beaumont has been studying the use of low-dose radiation therapy as a treatment for Alzheimer’s disease. One of the first worldwide to take this approach, the Food and Drug Administration (FDA) gave them permission for in-human trials.
This study is designed to assess the safety and toxicity/adverse events associated with the use of low dose fractionated whole brain irradiation in those patients who have been diagnosed with probable Alzheimer’s disease, according to the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer’s Disease and Related Disorders Association (NINCDS-ADRDA) criteria.
As a secondary goal, it will establish whether or not the intervention with low dose whole brain irradiation might change the recognized progression of Alzheimer’s Disease. The investigators will also collect information from the AMYVID ® (florbetaben F 18 Injection) positron emission tomography (PET) Scans to determine if there is any correlation between neurocognitive/quality of life scores and changes in amyloid plaque size, number and location.
The Michigan-based investigators seek participants with moderate stage Alzheimer’s disease for whole-brain radiation treatments. The patients who match the inclusion criteria and who sign informed consent will receive treatments for a duration of five consecutive days for 15 minutes or less on each day.
Who is Beaumont Research Institute
Beaumont Research Institute is a research division within Beaumont Hospitals in Michigan. It has grown directly out of their commitment to high-quality patient care. The research institute was established over 30 years ago on the campus of Beaumont, Royal Oak. They are actively engaged in drug and device development and testing, patient care outcomes, and preclinical and laboratory research.
Beaumont applies in applied clinical research as well as clinical trials with more than 350 clinical investigators in over 34 departments conducting clinical trials using $28.7 million in research grants from government, foundation and commercial sources.
The research institute is part of Beaumont Health System, a not-for-profit organization in southeast Michigan; the organization generates a net revenue approaching $5 billion. The system consists of eight hospitals with nearly 3,500 beds and 187 outpatient sites with nearly 5,000 physicians and more than 38,000 employees.
Examples of Beaumont funding partners include:
· National Institutes of Health
· U.S. Department of Defense
· American College of Surgeons Oncology Group
· American College of Radiology Imaging
· Pharmaceutical and Biotech companies
· Private foundations
The study is occurring at two sites including 1) Beaumont Hospital in Farmington Hills, MI under the direction of principal investigator James Fontanesi and 2) Beaumont Hospital, Royal Oak, MI under the direction of principal investigator Prakash Chinnaiyan.
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