Low Dose Ionizing Radiation Using CT Scans as a Potential Therapy for Alzheimer's Dementia: A Pilot Study
Condition: Dementia Alzheimers
MeSH terms: Dementia; Alzheimer Disease
Study type: Interventional

Summary: 
      The goal of this project is to determine whether low doses of ionizing radiation (LDIR) from
      repeat CT scanning improves function, cognition and/or behavior in severe AD.
    

Detailed description: 
      Alzheimer's dementia (AD) is a disorder of uncertain cause and pathogenesis that primarily
      affects older adults. It accounts for more than 50 percent of cases of dementia in the
      elderly and is a leading source of morbidity and mortality in the aging population. The most
      essential and often earliest symptom is selective memory impairment. While treatments can
      improve some symptoms, there is no cure or disease-modifying therapy, and the disease
      inevitably progresses in all patients. The mainstay of management is still symptomatic
      treatment of behavioral disturbances, environmental manipulations to prevent behavioural
      disturbances, and counseling with respect to safety issues.

      The goal of this project is to determine whether low doses of ionizing radiation (LDIR) from
      repeat CT scanning improves function, cognition and/or behavior in severe AD. This is based
      upon the treatments given in 2015 to a patient in hospice in the USA with advanced AD. On
      July 23, she received two CT scans of her brain. Two weeks later she received a third CT
      scan, and two weeks after this, a fourth CT scan. She partially improved and was discharged
      to an Alzheimer care home.

      In terms of the mechanism whereby CT scanning might lead to improvement, reactive oxygen
      species (ROS) are produced abundantly and constantly by aerobic metabolism in all organisms,
      damaging biomolecules including those in the brain. AD is postulated to be caused by the
      accumulation of oxidative stress damage in the brain that was not prevented, repaired or
      removed by the patient's own biological protective mechanisms. These systems, characterized
      genetically, operate against all toxins regardless of whether they are produced endogenously
      or by external physical, chemical or biological agents. As people age, their protection
      systems become progressively weaker. LDIR is postulated to stimulate adaptive protection
      systems. This may produce beneficial effects including improvement in AD symptoms. With about
      three-quarters of human tissue being water, most of the initial radiation-induced damage is
      radiolysis of water, producing ROS and hydrogen peroxide (H2O2). LDIR leads to mild oxidative
      stress and strong signaling, which up-regulates protection.The degree of stimulation likely
      depends upon individual genetic factors.

      CT scans are approved for clinical diagnostic imaging. Approval will be requested from the
      Research Ethics Board (REB) at Baycrest Health Sciences and from Health Canada to use CT
      scanning for the experimental treatment of AD. If this pilot study is successful, i.e., if
      improvement is observed in the participants, then a proposal will be prepared for more
      comprehensive clinical studies of this novel treatment.
    

Intervention name(s): CT scan
Intervention type(s): Radiation
Intervention description(s): Participants will receive the first LDIR treatment in one session on the same day, i.e., two CT scans of the brain that delivers a total X-ray dose (CTDIvol)10 of about 80 mGy. Participants will then be transported back to Baycrest Health Sciences. Participants will receive another LDIR treatment, i.e. a single CT scan of the brain (40 mGy), 2 weeks after the first session. They will receive a third LDIR treatment, i.e., a single CT scan of the brain (40 mGy), 2 weeks after the second session. Date, time and X-ray dose will be recorded for each participant and sent to their family physician for entry into in their health record.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment