Low Dose Ionizing Radiation Using CT Scans as a Potential Therapy for Alzheimer's Dementia: A Pilot Study (LDIR-CT-AD)

February 28, 2022 updated by: Jerry M Cuttler, Baycrest

Low Dose Ionizing Radiation Using CT Scans as a Potential Therapy for Alzheimer's Dementia (LDIR-CT-AD) Trial: A Pilot Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M6A 2E1
        • Baycrest Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years to 90 years (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Males or females with severe AD dementia (MMSE<12) between the ages of 70 to 90 years.
  2. Meet the criteria of AD (NIA-AA).
  3. If on any of the following medications: acetylcholinesterase inhibitors and/or memantine, participants must be on a stable dose for at least 60 days.
  4. Clinically stable for at least 3 months.

Exclusion Criteria:

  1. Current or past history of malignancy.
  2. Previous history of radiotherapy.
  3. Neurological disorder other than AD.
  4. Currently receiving other experimental treatments.
  5. Clinical or imaging evidence of stroke (with more than 1-2 lacunar infarcts on CT scan or MRI).
  6. Major depression, bipolar affective disorder or psychosis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: CT scan subjects
Three participants with severe Alzheimer's dementia will be studied
Radiation: CT scan
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alzheimer Disease Functional Assessment and Change Scale (ADFACS)
Time Frame: 20 minutes
is a specific scale for the functional assessment of people with Alzheimer Disease. A number of specific descriptions of performance levels for each item is offered, and the caregiver is asked to identify the one that most accurately describes the patient's performance . The scale consists of 16 items for the assessment of ADL, i.e. 6 items for BADL, 10 for IADL. items are scored from 0 to 4: 0 = no impairment, 1 = mild impairment, 2 = moderate impairment, 3 = severe impairment and 4 = nonassessable, with a range from 0 to 30. BADL items are scored from 0 to 5: 0 = no impairment, 1 = mild impairment, 2 = moderate impairment, 3 = severe impairment, 4 = very severe impairment and 5 = nonassessable, with a range from 0 to 24. In each part, the 'nonassessable' answer is substituted by an estimation from the average of the responded items. The total score (IADL + BADL) ranges from 0 to 54 (from best to worst).
20 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severe Impairment Battery (SIB)
Time Frame: 30 minutes
to assess cognition
30 minutes
Cohen-Mansfield Agitation Index (CMAI)
Time Frame: 30 minutes
The Cohen-Mansfield Agitation Index (CMAI) is a caregivers' rating questionnaire consisting of 29 agitated behaviours, each rated on a 7-point scale of frequency. It assesses the frequency of agitated behaviours in elderly persons in the long-term care setting.
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baycrest

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 8, 2019

Primary Completion (ACTUAL)

April 1, 2020

Study Completion (ACTUAL)

April 1, 2020

Study Registration Dates

First Submitted

July 10, 2018

First Submitted That Met QC Criteria

July 20, 2018

First Posted (ACTUAL)

July 24, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 2, 2022

Last Update Submitted That Met QC Criteria

February 28, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Baycrest REB # 18-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The purpose of the information disclosure is for review by a research ethics board committee only, and is of a privileged and confidential nature.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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