Study of Low Dose Whole Brain Irradiation in the Treatment of Alzheimer's Disease

NCT ID: NCT02359864

Last Updated: 2023-01-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-01
• Study Completion Date: 2021-02-03

Brief Summary

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 florbetaben F 18 Injection (AMYVID®) 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.

Detailed Description

An initial 15 patients will be enrolled in the first treatment scheme (5 daily fractions of 2 Gy) and will be followed for 12 months after completion of treatment to assess safety and any toxicity/adverse events associated with treatment. In Arm 1 the 15 study participants will be enrolled in total at Botsford Radiation Oncology Center and William Beaumont Hospital (Royal Oak Campus). Once a total combined 15 patients are entered this Arm will be closed.

The second treatment arm will not be used until the last patient in the first dose arm has completed all follow up. At that point patients #16-30 will be enrolled in the second dose arm (10 daily fractions of 2 Gy). In Arm 2 the 15 study participants will be enrolled in total at both Botsford Hospital Radiation Oncology Center and William Beaumont Hospital (Royal Oak Campus). Once a total combined 15 patients are entered this Arm will be closed.

A total of 30 patients will be enrolled and each will be followed for 12 months to assess safety and toxicity/adverse events.

Conditions

Alzheimer's Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort One

An initial 15 patients will be enrolled in the first treatment scheme (5 daily fractions of 2 Gy) and will be followed for 12 months after completion of treatment to assess safety and any toxicity/adverse events associated with treatment. 15 patients will be enrolled and each will be followed for 12 months to assess safety and toxicity/adverse events.

Group Type: EXPERIMENTAL

5 daily fractions of 2 Gy

Intervention Type: RADIATION

Whole Brain Irradiation to treat Alzheimer's Disease

Cohort Two

The second treatment arm will not be used until the last patient in the first dose arm has completed all follow up. At that point patients

#16-30 will be enrolled in the second dose arm (10 daily fractions of 2 Gy). 15 patients will be enrolled and each will be followed for 12 months to assess safety and toxicity/adverse events.

Group Type: EXPERIMENTAL

10 daily fractions of 2 Gy

Intervention Type: RADIATION

Whole Brain Irradiation to treat Alzheimer's Disease

Interventions

5 daily fractions of 2 Gy

Whole Brain Irradiation to treat Alzheimer's Disease

Intervention Type: RADIATION

10 daily fractions of 2 Gy

Whole Brain Irradiation to treat Alzheimer's Disease

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

Criteria for Eligibility (All responses must be YES)

Patients must meet all eligibility criteria to be included in the study:

1. Must be 55 years of age or older

2. Patient must meet NINCDS-ADRDA criteria for Alzheimer's Disease

3. Patient must be able to complete Mini-Mental Examination (MMSE) and Alzheimer's Disease Assessment Scale - Cognitive (ADAS-Cog) questionnaire Score Sheets

4. Patient has a Rosen Modified Hachinski Ischemic Score of less than or equal to 4

5. Patient has a MMSE score of between 10-20

6. Patient has estimated survival of greater than 12 months

7. Patient or legally authorized representative must be able to give consent

Exclusion Criteria

Patients will be excluded from the study if they meet any of the following criteria:

1. The patient has a history of cancer except non-melanoma skin cancer

2. Patient is taking anti-epileptic medication.

3. Dermatological skin disease of the scalp

4. Patient taking Alzheimer medication within the last 3 months, i.e. Exelon, Aricept, Namenda, Reminyl or Ebixa.

5. Current presence of a clinically significant major psychiatric disorder (e.g. major depressive disorder, bipolar disorder, schizophrenia, etc., according to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV))

6. Patient currently participating in another Clinical Trial.

7. Patient and legally authorized representative unable to give informed consent

8. Patient with history of focal neurological deficits (with the exception of vibratory peripheral neuropathy)

9. Non-Alzheimer dementia

10. Patient has previous history of central nervous system radiation

11. Patient has evidence of substance abuse (alcohol / or other drugs of dependence) during previous 12 months

12. History of subdural hygroma / subdural hematoma

13. History of cerebral infection / hemorrhage.

14. History that the patient is immunocompromised

15. History of seizure activity

16. History of hydrocephalus

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

William Beaumont Hospitals

OTHER

Sponsor Role: lead

Responsible Party

James Fontanesi, MD

Staff physician, Radiation Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

James Fontanesi, MD

Role: PRINCIPAL_INVESTIGATOR

William Beaumont Hospitals

Locations

Beaumont Health

Farmington Hills, Michigan, United States

Beaumont Health

Royal Oak, Michigan, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2016-088; 2017-471

Identifier Type: -

Identifier Source: org_study_id