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

NCT03597360 | Completed DMC

• 1 other identifier: Baycrest REB # 18-02
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dementia Alzheimers

Outcome Measures

Primary Outcomes (1)

• Alzheimer Disease Functional Assessment and Change Scale (ADFACS)

  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 Outcomes (2)

• Severe Impairment Battery (SIB)

  30 minutes

• Cohen-Mansfield Agitation Index (CMAI)

  30 minutes

Study Arms (1)

CT scan subjects

EXPERIMENTAL

Three participants with severe Alzheimer's dementia will be studied

Radiation: CT scan

Interventions

CT scan RADIATION

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.

CT scan subjects

Eligibility Criteria

• Age: 70 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Baycrest: lead

Study Sites (1)

Baycrest Health Sciences

Toronto, Ontario, M6A 2E1, Canada

Location

Related Publications (17)

• Ballard C, Gauthier S, Corbett A, Brayne C, Aarsland D, Jones E. Alzheimer's disease. Lancet. 2011 Mar 19;377(9770):1019-31. doi: 10.1016/S0140-6736(10)61349-9. Epub 2011 Mar 1.

  PMID: 21371747 RESULT

• Cuttler JM, Moore ER, Hosfeld VD, Nadolski DL. Treatment of Alzheimer Disease With CT Scans: A Case Report. Dose Response. 2016 Apr 1;14(2):1559325816640073. doi: 10.1177/1559325816640073. eCollection 2016 Apr-Jun.

  PMID: 27103883 RESULT

• Cuttler JM, Moore ER, Hosfeld VD, Nadolski DL. Update on a Patient With Alzheimer Disease Treated With CT Scans. Dose Response. 2017 Feb 17;15(1):1559325817693167. doi: 10.1177/1559325817693167. eCollection 2017 Jan-Mar. No abstract available.

  PMID: 28321176 RESULT

• Pollycove M, Feinendegen LE. Radiation-induced versus endogenous DNA damage: possible effect of inducible protective responses in mitigating endogenous damage. Hum Exp Toxicol. 2003 Jun;22(6):290-306; discussion 307, 315-7, 319-23. doi: 10.1191/0960327103ht365oa.

  PMID: 12856953 RESULT

• Sies H, Berndt C, Jones DP. Oxidative Stress. Annu Rev Biochem. 2017 Jun 20;86:715-748. doi: 10.1146/annurev-biochem-061516-045037. Epub 2017 Apr 24.

  PMID: 28441057 RESULT

• Feinendegen LE, Pollycove M, Neumann RD. Low-dose cancer risk modeling must recognize up-regulation of protection. Dose Response. 2009 Dec 10;8(2):227-52. doi: 10.2203/dose-response.09-035.Feinendegen.

  PMID: 20585440 RESULT

• Sies H. Hydrogen peroxide as a central redox signaling molecule in physiological oxidative stress: Oxidative eustress. Redox Biol. 2017 Apr;11:613-619. doi: 10.1016/j.redox.2016.12.035. Epub 2017 Jan 5.

  PMID: 28110218 RESULT

• Sies H, Feinendegen LE. Radiation Hormesis: The Link to Nanomolar Hydrogen Peroxide. Antioxid Redox Signal. 2017 Sep 20;27(9):596-598. doi: 10.1089/ars.2017.7233. Epub 2017 Aug 7.

  PMID: 28699353 RESULT

• Feinendegen LE, Cuttler JM. Biological Effects From Low Doses and Dose Rates of Ionizing Radiation: Science in the Service of Protecting Humans, a Synopsis. Health Phys. 2018 Jun;114(6):623-626. doi: 10.1097/HP.0000000000000833.

  PMID: 29521814 RESULT

• Manero RM, Casals-Coll M, Sanchez-Benavides G, Rodriguez-de los Reyes ON, Aguilar M, Badenes D, Molinuevo JL, Robles A, Barquero MS, Antunez C, Martinez-Parra C, Frank-Garcia A, Fernandez M, Blesa R, Pena-Casanova J; NEURONORMA Study Team. Diagnostic validity of the Alzheimer's disease functional assessment and change scale in mild cognitive impairment and mild to moderate Alzheimer's disease. Dement Geriatr Cogn Disord. 2014;37(5-6):366-75. doi: 10.1159/000350800. Epub 2014 Feb 18.

  PMID: 24556708 RESULT

• Panisset M, Roudier M, Saxton J, Boller F. Severe impairment battery. A neuropsychological test for severely demented patients. Arch Neurol. 1994 Jan;51(1):41-5. doi: 10.1001/archneur.1994.00540130067012.

  PMID: 8274108 RESULT

• Cohen-Mansfield J. Agitated behaviors in the elderly. II. Preliminary results in the cognitively deteriorated. J Am Geriatr Soc. 1986 Oct;34(10):722-7. doi: 10.1111/j.1532-5415.1986.tb04303.x.

  PMID: 3760436 RESULT

• Jack CR Jr, Albert MS, Knopman DS, McKhann GM, Sperling RA, Carrillo MC, Thies B, Phelps CH. Introduction to the recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011 May;7(3):257-62. doi: 10.1016/j.jalz.2011.03.004. Epub 2011 Apr 21.

  PMID: 21514247 RESULT

• Sakamoto K. Radiobiological basis for cancer therapy by total or half-body irradiation. Nonlinearity Biol Toxicol Med. 2004 Oct;2(4):293-316. doi: 10.1080/15401420490900254.

  PMID: 19330149 RESULT

• Pollycove M. Radiobiological basis of low-dose irradiation in prevention and therapy of cancer. Dose Response. 2006 Nov 27;5(1):26-38. doi: 10.2203/dose-response.06-112.Pollycove.

  PMID: 18648556 RESULT

• Lemon JA, Phan N, Boreham DR. Single CT Scan Prolongs Survival by Extending Cancer Latency in Trp53 Heterozygous Mice. Radiat Res. 2017 Oct;188(4.2):505-511. doi: 10.1667/RR14576.1. Epub 2017 Jul 25.

  PMID: 28742468 RESULT

• Lemon JA, Phan N, Boreham DR. Multiple CT Scans Extend Lifespan by Delaying Cancer Progression in Cancer-Prone Mice. Radiat Res. 2017 Oct;188(4.2):495-504. doi: 10.1667/RR14575.1. Epub 2017 Jul 25.

  PMID: 28741984 RESULT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: July 10, 2018
• First Posted: July 24, 2018
• Study Start: January 8, 2019
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: March 2, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)