Back to resultsStudy of Low Dose Whole Brain Irradiation in the Treatment of Alzheimer's Disease
Primary Purpose
Alzheimer's Disease
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
5 daily fractions of 2 Gy
10 daily fractions of 2 Gy
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer's Disease focused on measuring radiation treatment
Eligibility Criteria
Inclusion Criteria:
Criteria for Eligibility (All responses must be YES)
Inclusion Criteria:
Patients must meet all eligibility criteria to be included in the study:
- Must be 55 years of age or older
- Patient must meet NINCDS-ADRDA criteria for Alzheimer's Disease
- Patient must be able to complete Mini-Mental Examination (MMSE) and ADAS-Cog Score Sheets
- Patient has a Rosen Modified Hachinski Ischemic Score of less than or equal to 4
- Patient has a MMSE score of between 10-20
- Patient has estimated survival of greater than 12 months
- 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:
- The patient has a history of cancer except non-melanoma skin cancer
- Patient is taking anti-epileptic medication.
- Dermatological skin disease of the scalp
- Patient taking Alzheimer medication within the last 3 months, i.e. Exelon, Aricept, Namenda, Reminyl or Ebixa.
- 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))
- Patient currently participating in another Clinical Trial.
- Patient and legally authorized representative unable to give informed consent
- Patient with history of focal neurological deficits (with the exception of vibratory peripheral neuropathy)
- Non-Alzheimer dementia
- Patient has previous history of central nervous system radiation
- Patient has evidence of substance abuse (alcohol / or other drugs of dependence) during previous 12 months
- History of subdural hygroma / subdural hematoma
- History of cerebral infection / hemorrhage.
- History that the patient is immunocompromised
- History of seizure activity
- History of hydrocephalus
Sites / Locations
- Beaumont Health
- Beaumont Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Cohort One
Cohort Two
Arm 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. 15 patients will be enrolled and each will be followed for 12 months to assess safety and toxicity/adverse events.
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.
Outcomes
Primary Outcome Measures
Common Terminology Toxicity Criteria for Adverse Events (CTCAE) Version 5.0 - 6 Weeks
To assess a change from baseline in adverse conditions, utilizing Common Terminology Toxicity Criteria (Version 5.0) assessing skin, eyes, ears, and central nervous system at 6 weeks post-treatment. Each condition/event will be given a score based on severity . The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each adverse event (AE): (Grade 1=1 point, Grade 2=2 points, Grade 3=3 points, Grade 4=4 points. Grade 5=5 points) and event scores added to produce a total patient score. Minimum score is zero, which represents no adverse events. Maximum score is 72. A higher score means a worse outcome. The total patient score at baseline subtracted from the total score at 6 weeks is reported. A positive number indicates an increase in adverse conditions, while a negative number indicates decreased adverse conditions.
Common Terminology Toxicity Criteria (CTCAE) Version 5.0 - 3 Months
To assess a change from baseline in adverse conditions, utilizing Common Terminology Toxicity Criteria (Version 5.0) assessing skin, eyes, ears, and central nervous system at 3 months post-treatment. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE: (Grade 1=1 point, Grade 2=2 points, Grade 3=3 points, Grade 4=4 points. Grade 5=5 points) and event scores added to produce a total patient score. Minimum score is zero, which represents no adverse events. Maximum score is 72. A higher score means a worse outcome. The total patient score at baseline subtracted from the total score at 3 months is reported. A positive number indicates an increase in adverse conditions, while a negative number indicates decreased adverse conditions.
Common Terminology Toxicity Criteria (Version 5.0) - 6 Months
To assess a change from baseline in adverse conditions, utilizing Common Terminology Toxicity Criteria (Version 5.0) assessing skin, eyes, ears, and central nervous system at 6 months post-treatment. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE: (Grade 1=1 point, Grade 2=2 points, Grade 3=3 points, Grade 4=4 points. Grade 5=5 points) and event scores added to produce a total patient score. Minimum score is zero, which represents no adverse events. Maximum score is 72. A higher score means a worse outcome. The total patient score at baseline subtracted from the total score at 6 months is reported. A positive number indicates an increase in adverse conditions, while a negative number indicates decreased adverse conditions.
Common Terminology Toxicity Criteria (Version 5.0) - 12 Months
To assess a change from baseline in adverse conditions, utilizing Common Terminology Toxicity Criteria (Version 5.0) assessing skin, eyes, ears, and central nervous system at 12 months post-treatment. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE: (Grade 1=1 point, Grade 2=2 points, Grade 3=3 points, Grade 4=4 points. Grade 5=5 points) and event scores added to produce a total patient score. Minimum score is zero, which represents no adverse events. Maximum score is 72. A higher score means a worse outcome. The total patient score at baseline subtracted from the total score at 12 months is reported. A positive number indicates an increase in adverse conditions, while a negative number indicates decreased adverse conditions.
Secondary Outcome Measures
Florbetaben F 18 Injection (AMYVID) Positron Emission Tomography (PET) Scan: Change in "Positive" or "Negative" Determination
The number of patients with a change in amyloid plaque burden on AMYVID PET imaging from baseline to 4 month post-treatment scans, based on an overall "positive" or "negative" determination using Eli-Lilly AMYVID criteria. A positive scan indicates moderate to frequent amyloid neuritic plaques. A negative scan indicates sparse to no neuritic plaques.
Neurocognitive Function - MMSE (Mini Mental Status Exam) 6 Weeks Change From Baseline
Change at 6 weeks post-treatment from the pretreatment neurocognitive evaluation utilizing the Mini Mental Status Exam (MMSE) tool; a 30-point questionnaire for assessing cognitive function. Minimum value 0, maximum value 30. Higher score means better outcome. Pretreatment total score subtracted from 6-week total score will be reported.
Neurocognitive Function - MMSE (Mini Mental Status Exam) 3 Months Change From Baseline
Change at 3 months post-treatment from the pretreatment neurocognitive evaluation utilizing the Mini Mental Status Exam (MMSE) tool; a 30-point questionnaire for assessing cognitive function. Minimum value 0, maximum value 30. Higher score means better outcome. Pretreatment total score subtracted from 3-month total score will be reported.
Neurocognitive Function - MMSE (Mini Mental Status Exam) 6 Months Change From Baseline
Change at 6 months post-treatment from the pretreatment neurocognitive evaluation utilizing the Mini Mental Status Exam (MMSE) tool; a 30-point questionnaire for assessing cognitive function. Minimum value 0, maximum value 30. Higher score means better outcome. Pretreatment total score subtracted from 6-month total score will be reported.
Neurocognitive Function - MMSE (Mini Mental Status Exam) 12 Months Change From Baseline
Change at 12 months post-treatment from the pretreatment neurocognitive evaluation utilizing the Mini Mental Status Exam (MMSE) tool; a 30-point questionnaire for assessing cognitive function. Minimum value 0, maximum value 30. Higher score means better outcome. Pretreatment total score subtracted from 12-month total score will be reported.
Neurocognitive Function - ADAS-Cog - 6 Weeks Change From Baseline
Change at 6 weeks post-treatment from the pretreatment neurocognitive evaluation utilizing The Alzheimer's Disease Assessment Scale Cognitive Scales (ADAS-Cog), an 11 part questionnaire that provides a weighted score of cognitive function. Minimum score 0, maximum score 70, with higher score indicating worse outcome. Pretreatment total score subtracted from 6-week total score will be reported. Negative numbers indicate an improvement in cognition. Positive numbers indicate a worsening cognition.
Neurocognitive Function - ADAS-Cog - 3 Months Change From Baseline
Change at 3 months post-treatment from the pretreatment neurocognitive evaluation utilizing The Alzheimer's Disease Assessment Scale Cognitive Scales (ADAS-Cog), an 11 part questionnaire that provides a weighted score of cognitive function. Minimum score 0, maximum score 70, with higher score indicating worse outcome. Pretreatment total score subtracted from 3-month total score will be reported. Negative numbers indicate an improvement in cognition. Positive numbers indicate a worsening cognition.
Neurocognitive Function - ADAS-Cog - 6 Months Change From Baseline
Change at 6 months post-treatment from the pretreatment neurocognitive evaluation utilizing The Alzheimer's Disease Assessment Scale Cognitive Scales (ADAS-Cog), an 11 part questionnaire that provides a weighted score of cognitive function. Minimum score 0, maximum score 70, with higher score indicating worse outcome. Pretreatment total score subtracted from 6-month total score will be reported. Negative numbers indicate an improvement in cognition. Positive numbers indicate a worsening cognition.
Neurocognitive Function - ADAS-Cog - 12 Months Change From Baseline
Change at 12 months post-treatment from the pretreatment neurocognitive evaluation utilizing The Alzheimer's Disease Assessment Scale Cognitive Scales (ADAS-Cog), an 11 part questionnaire that provides a weighted score of cognitive function. Minimum score 0, maximum score 70, with higher score indicating worse outcome. Pretreatment total score subtracted from 12-month total score will be reported. Negative numbers indicate an improvement in cognition. Positive numbers indicate a worsening cognition.
Neurocognitive Function - QOL-AD - 6 Weeks Change From Baseline
Change at 6 weeks post-treatment from the pretreatment neurocognitive evaluation utilizing The Alzheimer's Quality of Life Questionnaire (QOL-AD) tool; a 13 item assessment with each question scored on a 4 point scale where 1=poor quality of life and 4=excellent quality of life. A cumulative score from all items will be collected (min 13 indicates poor QOL, max 52 indicates excellent QOL) and pretreatment score subtracted from 6-week score. A negative number indicates a decreased quality of life. A positive number indicates an improved quality of life
Neurocognitive Function - QOL-AD - 3 Months Change From Baseline
Change at 3 months post-treatment from the pretreatment neurocognitive evaluation utilizing The Alzheimer's Quality of Life Questionaire (QOL-AD) tool; a 13 item assessment with each question scored on a 4 point scale where 1=poor quality of life and 4=excellent quality of life. A cumulative score from all items will be collected (min 13 indicates poor QOL, max 52 indicates excellent QOL) and pretreatment score subtracted from 3-month score. A negative number indicates a decreased quality of life. A positive number indicates an improved quality of life.
Neurocognitive Function - QOL-AD - 6 Months Change From Baseline
Change at 6 months post-treatment from the pretreatment neurocognitive evaluation utilizing The Alzheimer's Quality of Life Questionaire (QOL-AD) tool; a 13 item assessment with each question scored on a 4 point scale where 1=poor quality of life and 4=excellent quality of life. A cumulative score from all items will be collected (min 13 indicates poor QOL, max 52 indicates excellent QOL) and and pretreatment score subtracted from 6-month score. A negative number indicates a decreased quality of life. A positive number indicates an improved quality of life.
Neurocognitive Function - QOL-AD - 12 Months Change From Baseline
Change at 12 months post-treatment from the pretreatment neurocognitive evaluation utilizing The Alzheimer's Quality of Life Questionaire (QOL-AD) tool; a 13 item assessment with each question scored on a 4 point scale where 1=poor quality of life and 4=excellent quality of life. A cumulative score from all items will be collected (min 13 indicates poor QOL, max 52 indicates excellent QOL) and pretreatment score subtracted from 12-month score. A negative number indicates a decreased quality of life. A positive number indicates an improved quality of life.
Neurocognitive Function - QUALID- 6 Weeks Change From Baseline
Change at 6 weeks post-treatment from the pretreatment neurocognitive evaluation utilizing The Quality of Life in Late Stage Dementia (QUALID) tool; an 11 item assessment with each question scored on a 5 point scale completed by caregiver, where 5=poor quality of life and 1=excellent quality of life. A cumulative score from all items will be collected (min 11 indicates excellent quality of life, max 55 indicates poor quality of life) and pretreatment score subtracted from 6-week score. A positive number indicates a decreased quality of life. A negative number indicates an improved quality of life.
Neurocognitive Function - QUALID- 3 Months Change From Baseline
Change at 3 months post-treatment from the pretreatment neurocognitive evaluation utilizing The Quality of Life in Late Stage Dementia (QUALID) tool; an 11 item assessment with each question scored on a 5 point scale completed by a patient or caregiver, where 5=poor quality of life and 1=excellent quality of life. A cumulative score from all items will be collected (min 11 indicates excellent quality of life, max 55 indicates poor quality of life) and pretreatment score subtracted from 3-month score. A positive number indicates a decreased quality of life. A negative number indicates an improved quality of life.
Neurocognitive Function - QUALID- 6 Months Change From Baseline
Change at 6 months post-treatment from the pretreatment neurocognitive evaluation utilizing The Quality of Life in Late Stage Dementia (QUALID) tool; an 11 item assessment with each question scored on a 5 point scale completed by a patient or caregiver, where 5=poor quality of life and 1=excellent quality of life. A cumulative score from all items will be collected (min 11 indicates excellent quality of life, max 55 indicates poor quality of life) and pretreatment score subtracted from 6-month score. A positive number indicates a decreased quality of life. A negative number indicates an improved quality of life.
Neurocognitive Function - QUALID- 12 Months Change From Baseline
Change at 12 months post-treatment from the pretreatment neurocognitive evaluation utilizing The Quality of Life in Late Stage Dementia (QUALID) tool; an 11 item assessment with each question scored on a 5 point scale completed by a patient or caregiver, where 5=poor quality of life and 1=excellent quality of life. A cumulative score from all items will be collected (min 11 indicates excellent quality of life, max 55 indicates poor quality of life) and pretreatment score subtracted from 12-month score. A positive number indicates a decreased quality of life. A negative number indicates an improved quality of life.
Florbetaben F 18 Injection (AMYVID) Positron Emission Tomography (PET) Scan: Change From Baseline to 4 Months in Standardized Uptake Value Ratio (SUVr) for Frontal Region of the Brain Compared to Cerebellum
SUVr is a measure of the amount of radiotracer activity bound to beta amyloid plaque in an individual region of brain tissue compared to radiotracer activity in the cerebellum, which is rarely involved by neuritic plaques. An elevated ratio >1.10 indicates a strong likelihood of significant underlying neuritic plaque burden. The percent change from baseline to 4-month scans in the frontal region is reported (percent change is calculated by subtracting baseline value from 4-month value; the result is then divided by the baseline value and multiplied by 100 to give a percentage). A positive number (percentage) indicates an increase in SUVr and more plaque burden in the frontal region, while a negative number (percentage) indicates a decrease in SUVr and a reduction in plaque burden in the frontal region.
Florbetaben F 18 Injection (AMYVID) Positron Emission Tomography (PET) Scan: Change From Baseline to 4 Months in Standardized Uptake Value Ratio (SUVr) for Parietal Region of the Brain Compared to Cerebellum
SUVr is a measure of the amount of radiotracer activity bound to beta amyloid plaque in an individual region of brain tissue compared to radiotracer activity in the cerebellum, which is rarely involved by neuritic plaques. An elevated ratio >1.10 indicates a strong likelihood of significant underlying neuritic plaque burden. The percent change from baseline to 4-month scans in the parietal region is reported (percent change is calculated by subtracting baseline value from 4-month value; the result is then divided by the baseline value and multiplied by 100 to give a percentage). A positive number (percentage) indicates an increase in SUVr and more plaque burden in the parietal region, while a negative number (percentage) indicates a decrease in SUVr and a reduction in plaque burden in the parietal region.
Florbetaben F 18 Injection (AMYVID) Positron Emission Tomography (PET) Scan: Change From Baseline to 4 Months in Standardized Uptake Value Ratio (SUVr) for Precuneus Region of the Brain Compared to Cerebellum
SUVr is a measure of the amount of radiotracer activity bound to beta amyloid plaque in an individual region of brain tissue compared to radiotracer activity in the cerebellum, which is rarely involved by neuritic plaques. An elevated ratio >1.10 indicates a strong likelihood of significant underlying neuritic plaque burden. The percent change from baseline to 4-month scans in the precuneus region is reported (percent change is calculated by subtracting baseline value from 4-month value; the result is then divided by the baseline value and multiplied by 100 to give a percentage). A positive number (percentage) indicates an increase in SUVr and more plaque burden in the precuneus region, while a negative number (percentage) indicates a decrease in SUVr and a reduction in plaque burden in the precuneus region.
Florbetaben F 18 Injection (AMYVID) Positron Emission Tomography (PET) Scan: Change From Baseline to 4 Months in Standardized Uptake Value Ratio (SUVr) for Anterior Cingulate Gyrus Region of the Brain Compared to Cerebellum
SUVr is a measure of the amount of radiotracer activity bound to beta amyloid plaque in an individual region of brain tissue compared to radiotracer activity in the cerebellum, which is rarely involved by neuritic plaques. An elevated ratio >1.10 indicates a strong likelihood of significant underlying neuritic plaque burden. The percent change from baseline to 4-month scans in the anterior cingulate gyrus region is reported (percent change is calculated by subtracting baseline value from 4-month value; the result is then divided by the baseline value and multiplied by 100 to give a percentage). A positive number (percentage) indicates an increase in SUVr and more plaque burden in the anterior cingulate gyrus region, while a negative number (percentage) indicates a decrease in SUVr and a reduction in plaque burden in the anterior cingulate gyrus region.
Florbetaben F 18 Injection (AMYVID) Positron Emission Tomography (PET) Scan: Change From Baseline to 4 Months in Standardized Uptake Value Ratio (SUVr) for Posterior Cingulate Gyrus Region of the Brain Compared to Cerebellum
SUVr is a measure of the amount of radiotracer activity bound to beta amyloid plaque in an individual region of brain tissue compared to radiotracer activity in the cerebellum, which is rarely involved by neuritic plaques. An elevated ratio >1.10 indicates a strong likelihood of significant underlying neuritic plaque burden. The percent change from baseline to 4-month scans in the posterior cingulate gyrus region is reported (percent change is calculated by subtracting baseline value from 4-month value; the result is then divided by the baseline value and multiplied by 100 to give a percentage). A positive number (percentage) indicates an increase in SUVr and more plaque burden in the posterior cingulate gyrus region, while a negative number (percentage) indicates a decrease in SUVr and a reduction in plaque burden in the posterior cingulate gyrus region.
Florbetaben F 18 Injection (AMYVID) Positron Emission Tomography (PET) Scan: Change From Baseline to 4 Months in Standardized Uptake Value Ratio (SUVr) for Whole Brain Cortex Compared to Cerebellum
SUVr is a measure of the amount of radiotracer activity bound to beta amyloid plaque in an individual region of brain tissue compared to radiotracer activity in the cerebellum, which is rarely involved by neuritic plaques. An elevated ratio >1.10 indicates a strong likelihood of significant underlying neuritic plaque burden. The percent change from baseline to 4-month scans in the whole brain cortex relative to cerebellum is reported (percent change is calculated by subtracting baseline value from 4-month value; the result is then divided by the baseline value and multiplied by 100 to give a percentage). A positive number (percentage) indicates an increase in SUVr and more plaque burden in the whole brain cortex relative to cerebellum, while a negative number (percentage) indicates a decrease in SUVr and a reduction in plaque burden in the whole brain cortex relative to cerebellum.
Florbetaben F 18 Injection (AMYVID) Positron Emission Tomography (PET) Scan: Change From Baseline to 4 Months in Standardized Uptake Value Standard Deviation (SUV StdDev) From Normal Patients in SUVr Values for Frontal Region of the Brain
The metric SUV StdDev from normal utilizes a database of age matched, cognitively normal individuals to compare the SUV ratios for individual regions of the brain. An elevated SUV StdDev > 1.65 indicates a strong likelihood of significant underlying neuritic plaque burden. The percent change from baseline to 4-month scans in the frontal region is reported (percent change is calculated by subtracting baseline value from 4-month value; the result is then divided by the baseline value and multiplied by 100 to give a percentage). A positive number indicates an increase in SUV StdDev and more plaque burden in the frontal region, while a negative number indicates a decrease in SUV StdDev and a reduction in plaque burden in the frontal region
Florbetaben F 18 Injection (AMYVID) Positron Emission Tomography (PET) Scan: Change From Baseline to 4 Months in Standardized Uptake Value Standard Deviation (SUV StdDev) From Normal Patients in SUVr Values for Parietal Region of the Brain
The metric SUV StdDev from normal utilizes a database of age matched, cognitively normal individuals to compare the SUV ratios for individual regions of the brain. An elevated SUV StdDev > 1.65 indicates a strong likelihood of significant underlying neuritic plaque burden. The percent change from baseline to 4-month scans in the parietal region is reported (percent change is calculated by subtracting baseline value from 4-month value; the result is then divided by the baseline value and multiplied by 100 to give a percentage). A positive number indicates an increase in SUV StdDev and more plaque burden in the parietal region, while a negative number indicates a decrease in SUV StdDev and a reduction in plaque burden in the parietal region.
Florbetaben F 18 Injection (AMYVID) Positron Emission Tomography (PET) Scan: Change From Baseline to 4 Months in Standardized Uptake Value Standard Deviation (SUV StdDev) From Normal Patients in SUVr Values for Precuneus Region of the Brain
The metric SUV StdDev from normal utilizes a database of age matched, cognitively normal individuals to compare the SUV ratios for individual regions of the brain. An elevated SUV StdDev > 1.65 indicates a strong likelihood of significant underlying neuritic plaque burden. The percent change from baseline to 4-month scans in the precuneus region is reported (percent change is calculated by subtracting baseline value from 4-month value; the result is then divided by the baseline value and multiplied by 100 to give a percentage). A positive number indicates an increase in SUV StdDev and more plaque burden in the precuneus region, while a negative number indicates a decrease in SUV StdDev and a reduction in plaque burden in the precuneus region.
Florbetaben F 18 Injection (AMYVID) Positron Emission Tomography (PET) Scan: Change From Baseline to 4 Months in Standardized Uptake Value Standard Deviation (SUV StdDev) From Normal Patients in SUVr Values for Anterior Cingulate Gyrus Region of the Brain
The metric SUV StdDev from normal utilizes a database of age matched, cognitively normal individuals to compare the SUV ratios for individual regions of the brain. An elevated SUV StdDev > 1.65 indicates a strong likelihood of significant underlying neuritic plaque burden. The percent change from baseline to 4-month scans in the anterior cingulate gyrus region is reported (percent change is calculated by subtracting baseline value from 4-month value; the result is then divided by the baseline value and multiplied by 100 to give a percentage). A positive number indicates an increase in SUV StdDev and more plaque burden in the anterior cingulate gyrus region, while a negative number indicates a decrease in SUV StdDev and a reduction in plaque burden in the anterior cingulate gyrus region.
Florbetaben F 18 Injection (AMYVID) Positron Emission Tomography (PET) Scan: Change From Baseline to 4 Months in Standardized Uptake Value Standard Deviation (SUV StdDev) From Normal Patients in SUVr Values for Posterior Cingulate Gyrus Region of Brain
The metric SUV StdDev from normal utilizes a database of age matched, cognitively normal individuals to compare the SUV ratios for individual regions of the brain. An elevated SUV StdDev > 1.65 indicates a strong likelihood of significant underlying neuritic plaque burden. The percent change from baseline to 4-month scans in the posterior cingulate gyrus region is reported (percent change is calculated by subtracting baseline value from 4-month value; the result is then divided by the baseline value and multiplied by 100 to give a percentage). A positive number indicates an increase in SUV StdDev and more plaque burden in the posterior cingulate gyrus region, while a negative number indicates a decrease in SUV StdDev and a reduction in plaque burden in the posterior cingulate gyrus region.
Full Information
NCT ID
NCT02359864
First Posted
January 30, 2015
Last Updated
December 29, 2022
Sponsor
William Beaumont Hospitals
1. Study Identification
Unique Protocol Identification Number
NCT02359864
Brief Title
Study of Low Dose Whole Brain Irradiation in the Treatment of Alzheimer's Disease
Official Title
Phase I Feasibility Study of Low Dose Whole Brain Irradiation in the Treatment of Alzheimer's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Terminated
Why Stopped
Staffing and budget limitations. Administrative decision to halt enrollment due to coronavirus-19 (COVID) pandemic
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
February 3, 2021 (Actual)
Study Completion Date
February 3, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
William Beaumont Hospitals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
radiation treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single group pilot study of radiation treatment. The two arms are sequential dose increase.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort One
Arm Type
Experimental
Arm 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. 15 patients will be enrolled and each will be followed for 12 months to assess safety and toxicity/adverse events.
Arm Title
Cohort Two
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
5 daily fractions of 2 Gy
Intervention Description
Whole Brain Irradiation to treat Alzheimer's Disease
Intervention Type
Radiation
Intervention Name(s)
10 daily fractions of 2 Gy
Intervention Description
Whole Brain Irradiation to treat Alzheimer's Disease
Primary Outcome Measure Information:
Title
Common Terminology Toxicity Criteria for Adverse Events (CTCAE) Version 5.0 - 6 Weeks
Description
To assess a change from baseline in adverse conditions, utilizing Common Terminology Toxicity Criteria (Version 5.0) assessing skin, eyes, ears, and central nervous system at 6 weeks post-treatment. Each condition/event will be given a score based on severity . The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each adverse event (AE): (Grade 1=1 point, Grade 2=2 points, Grade 3=3 points, Grade 4=4 points. Grade 5=5 points) and event scores added to produce a total patient score. Minimum score is zero, which represents no adverse events. Maximum score is 72. A higher score means a worse outcome. The total patient score at baseline subtracted from the total score at 6 weeks is reported. A positive number indicates an increase in adverse conditions, while a negative number indicates decreased adverse conditions.
Time Frame
Baseline to 6 weeks post-treatment
Title
Common Terminology Toxicity Criteria (CTCAE) Version 5.0 - 3 Months
Description
To assess a change from baseline in adverse conditions, utilizing Common Terminology Toxicity Criteria (Version 5.0) assessing skin, eyes, ears, and central nervous system at 3 months post-treatment. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE: (Grade 1=1 point, Grade 2=2 points, Grade 3=3 points, Grade 4=4 points. Grade 5=5 points) and event scores added to produce a total patient score. Minimum score is zero, which represents no adverse events. Maximum score is 72. A higher score means a worse outcome. The total patient score at baseline subtracted from the total score at 3 months is reported. A positive number indicates an increase in adverse conditions, while a negative number indicates decreased adverse conditions.
Time Frame
Baseline 3 months post-treatment
Title
Common Terminology Toxicity Criteria (Version 5.0) - 6 Months
Description
To assess a change from baseline in adverse conditions, utilizing Common Terminology Toxicity Criteria (Version 5.0) assessing skin, eyes, ears, and central nervous system at 6 months post-treatment. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE: (Grade 1=1 point, Grade 2=2 points, Grade 3=3 points, Grade 4=4 points. Grade 5=5 points) and event scores added to produce a total patient score. Minimum score is zero, which represents no adverse events. Maximum score is 72. A higher score means a worse outcome. The total patient score at baseline subtracted from the total score at 6 months is reported. A positive number indicates an increase in adverse conditions, while a negative number indicates decreased adverse conditions.
Time Frame
6 months post-treatment
Title
Common Terminology Toxicity Criteria (Version 5.0) - 12 Months
Description
To assess a change from baseline in adverse conditions, utilizing Common Terminology Toxicity Criteria (Version 5.0) assessing skin, eyes, ears, and central nervous system at 12 months post-treatment. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE: (Grade 1=1 point, Grade 2=2 points, Grade 3=3 points, Grade 4=4 points. Grade 5=5 points) and event scores added to produce a total patient score. Minimum score is zero, which represents no adverse events. Maximum score is 72. A higher score means a worse outcome. The total patient score at baseline subtracted from the total score at 12 months is reported. A positive number indicates an increase in adverse conditions, while a negative number indicates decreased adverse conditions.
Time Frame
Baseline to12 months post-treatment
Secondary Outcome Measure Information:
Title
Florbetaben F 18 Injection (AMYVID) Positron Emission Tomography (PET) Scan: Change in "Positive" or "Negative" Determination
Description
The number of patients with a change in amyloid plaque burden on AMYVID PET imaging from baseline to 4 month post-treatment scans, based on an overall "positive" or "negative" determination using Eli-Lilly AMYVID criteria. A positive scan indicates moderate to frequent amyloid neuritic plaques. A negative scan indicates sparse to no neuritic plaques.
Time Frame
Baseline to 4 months post-treatment
Title
Neurocognitive Function - MMSE (Mini Mental Status Exam) 6 Weeks Change From Baseline
Description
Change at 6 weeks post-treatment from the pretreatment neurocognitive evaluation utilizing the Mini Mental Status Exam (MMSE) tool; a 30-point questionnaire for assessing cognitive function. Minimum value 0, maximum value 30. Higher score means better outcome. Pretreatment total score subtracted from 6-week total score will be reported.
Time Frame
Baseline to 6 weeks post-treatment
Title
Neurocognitive Function - MMSE (Mini Mental Status Exam) 3 Months Change From Baseline
Description
Change at 3 months post-treatment from the pretreatment neurocognitive evaluation utilizing the Mini Mental Status Exam (MMSE) tool; a 30-point questionnaire for assessing cognitive function. Minimum value 0, maximum value 30. Higher score means better outcome. Pretreatment total score subtracted from 3-month total score will be reported.
Time Frame
Baseline to 3 months post-treatment
Title
Neurocognitive Function - MMSE (Mini Mental Status Exam) 6 Months Change From Baseline
Description
Change at 6 months post-treatment from the pretreatment neurocognitive evaluation utilizing the Mini Mental Status Exam (MMSE) tool; a 30-point questionnaire for assessing cognitive function. Minimum value 0, maximum value 30. Higher score means better outcome. Pretreatment total score subtracted from 6-month total score will be reported.
Time Frame
Baseline to 6 months post-treatment
Title
Neurocognitive Function - MMSE (Mini Mental Status Exam) 12 Months Change From Baseline
Description
Change at 12 months post-treatment from the pretreatment neurocognitive evaluation utilizing the Mini Mental Status Exam (MMSE) tool; a 30-point questionnaire for assessing cognitive function. Minimum value 0, maximum value 30. Higher score means better outcome. Pretreatment total score subtracted from 12-month total score will be reported.
Time Frame
Baseline to 12 months post-treatment
Title
Neurocognitive Function - ADAS-Cog - 6 Weeks Change From Baseline
Description
Change at 6 weeks post-treatment from the pretreatment neurocognitive evaluation utilizing The Alzheimer's Disease Assessment Scale Cognitive Scales (ADAS-Cog), an 11 part questionnaire that provides a weighted score of cognitive function. Minimum score 0, maximum score 70, with higher score indicating worse outcome. Pretreatment total score subtracted from 6-week total score will be reported. Negative numbers indicate an improvement in cognition. Positive numbers indicate a worsening cognition.
Time Frame
Baseline to 6 weeks post-treatment
Title
Neurocognitive Function - ADAS-Cog - 3 Months Change From Baseline
Description
Change at 3 months post-treatment from the pretreatment neurocognitive evaluation utilizing The Alzheimer's Disease Assessment Scale Cognitive Scales (ADAS-Cog), an 11 part questionnaire that provides a weighted score of cognitive function. Minimum score 0, maximum score 70, with higher score indicating worse outcome. Pretreatment total score subtracted from 3-month total score will be reported. Negative numbers indicate an improvement in cognition. Positive numbers indicate a worsening cognition.
Time Frame
Baseline to 3 months post-treatment
Title
Neurocognitive Function - ADAS-Cog - 6 Months Change From Baseline
Description
Change at 6 months post-treatment from the pretreatment neurocognitive evaluation utilizing The Alzheimer's Disease Assessment Scale Cognitive Scales (ADAS-Cog), an 11 part questionnaire that provides a weighted score of cognitive function. Minimum score 0, maximum score 70, with higher score indicating worse outcome. Pretreatment total score subtracted from 6-month total score will be reported. Negative numbers indicate an improvement in cognition. Positive numbers indicate a worsening cognition.
Time Frame
Baseline to 6 months post-treatment
Title
Neurocognitive Function - ADAS-Cog - 12 Months Change From Baseline
Description
Change at 12 months post-treatment from the pretreatment neurocognitive evaluation utilizing The Alzheimer's Disease Assessment Scale Cognitive Scales (ADAS-Cog), an 11 part questionnaire that provides a weighted score of cognitive function. Minimum score 0, maximum score 70, with higher score indicating worse outcome. Pretreatment total score subtracted from 12-month total score will be reported. Negative numbers indicate an improvement in cognition. Positive numbers indicate a worsening cognition.
Time Frame
Baseline to 12 months post-treatment
Title
Neurocognitive Function - QOL-AD - 6 Weeks Change From Baseline
Description
Change at 6 weeks post-treatment from the pretreatment neurocognitive evaluation utilizing The Alzheimer's Quality of Life Questionnaire (QOL-AD) tool; a 13 item assessment with each question scored on a 4 point scale where 1=poor quality of life and 4=excellent quality of life. A cumulative score from all items will be collected (min 13 indicates poor QOL, max 52 indicates excellent QOL) and pretreatment score subtracted from 6-week score. A negative number indicates a decreased quality of life. A positive number indicates an improved quality of life
Time Frame
Baseline to 6 weeks post-treatment
Title
Neurocognitive Function - QOL-AD - 3 Months Change From Baseline
Description
Change at 3 months post-treatment from the pretreatment neurocognitive evaluation utilizing The Alzheimer's Quality of Life Questionaire (QOL-AD) tool; a 13 item assessment with each question scored on a 4 point scale where 1=poor quality of life and 4=excellent quality of life. A cumulative score from all items will be collected (min 13 indicates poor QOL, max 52 indicates excellent QOL) and pretreatment score subtracted from 3-month score. A negative number indicates a decreased quality of life. A positive number indicates an improved quality of life.
Time Frame
Baseline to 3 months post-treatment
Title
Neurocognitive Function - QOL-AD - 6 Months Change From Baseline
Description
Change at 6 months post-treatment from the pretreatment neurocognitive evaluation utilizing The Alzheimer's Quality of Life Questionaire (QOL-AD) tool; a 13 item assessment with each question scored on a 4 point scale where 1=poor quality of life and 4=excellent quality of life. A cumulative score from all items will be collected (min 13 indicates poor QOL, max 52 indicates excellent QOL) and and pretreatment score subtracted from 6-month score. A negative number indicates a decreased quality of life. A positive number indicates an improved quality of life.
Time Frame
Baseline to 6 months post-treatment
Title
Neurocognitive Function - QOL-AD - 12 Months Change From Baseline
Description
Change at 12 months post-treatment from the pretreatment neurocognitive evaluation utilizing The Alzheimer's Quality of Life Questionaire (QOL-AD) tool; a 13 item assessment with each question scored on a 4 point scale where 1=poor quality of life and 4=excellent quality of life. A cumulative score from all items will be collected (min 13 indicates poor QOL, max 52 indicates excellent QOL) and pretreatment score subtracted from 12-month score. A negative number indicates a decreased quality of life. A positive number indicates an improved quality of life.
Time Frame
Baseline to 12 months post-treatment
Title
Neurocognitive Function - QUALID- 6 Weeks Change From Baseline
Description
Change at 6 weeks post-treatment from the pretreatment neurocognitive evaluation utilizing The Quality of Life in Late Stage Dementia (QUALID) tool; an 11 item assessment with each question scored on a 5 point scale completed by caregiver, where 5=poor quality of life and 1=excellent quality of life. A cumulative score from all items will be collected (min 11 indicates excellent quality of life, max 55 indicates poor quality of life) and pretreatment score subtracted from 6-week score. A positive number indicates a decreased quality of life. A negative number indicates an improved quality of life.
Time Frame
Baseline to 6 weeks post-treatment
Title
Neurocognitive Function - QUALID- 3 Months Change From Baseline
Description
Change at 3 months post-treatment from the pretreatment neurocognitive evaluation utilizing The Quality of Life in Late Stage Dementia (QUALID) tool; an 11 item assessment with each question scored on a 5 point scale completed by a patient or caregiver, where 5=poor quality of life and 1=excellent quality of life. A cumulative score from all items will be collected (min 11 indicates excellent quality of life, max 55 indicates poor quality of life) and pretreatment score subtracted from 3-month score. A positive number indicates a decreased quality of life. A negative number indicates an improved quality of life.
Time Frame
Baseline to 3 months post-treatment
Title
Neurocognitive Function - QUALID- 6 Months Change From Baseline
Description
Change at 6 months post-treatment from the pretreatment neurocognitive evaluation utilizing The Quality of Life in Late Stage Dementia (QUALID) tool; an 11 item assessment with each question scored on a 5 point scale completed by a patient or caregiver, where 5=poor quality of life and 1=excellent quality of life. A cumulative score from all items will be collected (min 11 indicates excellent quality of life, max 55 indicates poor quality of life) and pretreatment score subtracted from 6-month score. A positive number indicates a decreased quality of life. A negative number indicates an improved quality of life.
Time Frame
Baseline to 6 months post-treatment
Title
Neurocognitive Function - QUALID- 12 Months Change From Baseline
Description
Change at 12 months post-treatment from the pretreatment neurocognitive evaluation utilizing The Quality of Life in Late Stage Dementia (QUALID) tool; an 11 item assessment with each question scored on a 5 point scale completed by a patient or caregiver, where 5=poor quality of life and 1=excellent quality of life. A cumulative score from all items will be collected (min 11 indicates excellent quality of life, max 55 indicates poor quality of life) and pretreatment score subtracted from 12-month score. A positive number indicates a decreased quality of life. A negative number indicates an improved quality of life.
Time Frame
12 months post-treatment
Title
Florbetaben F 18 Injection (AMYVID) Positron Emission Tomography (PET) Scan: Change From Baseline to 4 Months in Standardized Uptake Value Ratio (SUVr) for Frontal Region of the Brain Compared to Cerebellum
Description
SUVr is a measure of the amount of radiotracer activity bound to beta amyloid plaque in an individual region of brain tissue compared to radiotracer activity in the cerebellum, which is rarely involved by neuritic plaques. An elevated ratio >1.10 indicates a strong likelihood of significant underlying neuritic plaque burden. The percent change from baseline to 4-month scans in the frontal region is reported (percent change is calculated by subtracting baseline value from 4-month value; the result is then divided by the baseline value and multiplied by 100 to give a percentage). A positive number (percentage) indicates an increase in SUVr and more plaque burden in the frontal region, while a negative number (percentage) indicates a decrease in SUVr and a reduction in plaque burden in the frontal region.
Time Frame
Baseline to 4 months post-treatment
Title
Florbetaben F 18 Injection (AMYVID) Positron Emission Tomography (PET) Scan: Change From Baseline to 4 Months in Standardized Uptake Value Ratio (SUVr) for Parietal Region of the Brain Compared to Cerebellum
Description
SUVr is a measure of the amount of radiotracer activity bound to beta amyloid plaque in an individual region of brain tissue compared to radiotracer activity in the cerebellum, which is rarely involved by neuritic plaques. An elevated ratio >1.10 indicates a strong likelihood of significant underlying neuritic plaque burden. The percent change from baseline to 4-month scans in the parietal region is reported (percent change is calculated by subtracting baseline value from 4-month value; the result is then divided by the baseline value and multiplied by 100 to give a percentage). A positive number (percentage) indicates an increase in SUVr and more plaque burden in the parietal region, while a negative number (percentage) indicates a decrease in SUVr and a reduction in plaque burden in the parietal region.
Time Frame
Baseline to 4 months post-treatment
Title
Florbetaben F 18 Injection (AMYVID) Positron Emission Tomography (PET) Scan: Change From Baseline to 4 Months in Standardized Uptake Value Ratio (SUVr) for Precuneus Region of the Brain Compared to Cerebellum
Description
SUVr is a measure of the amount of radiotracer activity bound to beta amyloid plaque in an individual region of brain tissue compared to radiotracer activity in the cerebellum, which is rarely involved by neuritic plaques. An elevated ratio >1.10 indicates a strong likelihood of significant underlying neuritic plaque burden. The percent change from baseline to 4-month scans in the precuneus region is reported (percent change is calculated by subtracting baseline value from 4-month value; the result is then divided by the baseline value and multiplied by 100 to give a percentage). A positive number (percentage) indicates an increase in SUVr and more plaque burden in the precuneus region, while a negative number (percentage) indicates a decrease in SUVr and a reduction in plaque burden in the precuneus region.
Time Frame
Baseline to 4 months post-treatment
Title
Florbetaben F 18 Injection (AMYVID) Positron Emission Tomography (PET) Scan: Change From Baseline to 4 Months in Standardized Uptake Value Ratio (SUVr) for Anterior Cingulate Gyrus Region of the Brain Compared to Cerebellum
Description
SUVr is a measure of the amount of radiotracer activity bound to beta amyloid plaque in an individual region of brain tissue compared to radiotracer activity in the cerebellum, which is rarely involved by neuritic plaques. An elevated ratio >1.10 indicates a strong likelihood of significant underlying neuritic plaque burden. The percent change from baseline to 4-month scans in the anterior cingulate gyrus region is reported (percent change is calculated by subtracting baseline value from 4-month value; the result is then divided by the baseline value and multiplied by 100 to give a percentage). A positive number (percentage) indicates an increase in SUVr and more plaque burden in the anterior cingulate gyrus region, while a negative number (percentage) indicates a decrease in SUVr and a reduction in plaque burden in the anterior cingulate gyrus region.
Time Frame
Baseline to 4 months post-treatment
Title
Florbetaben F 18 Injection (AMYVID) Positron Emission Tomography (PET) Scan: Change From Baseline to 4 Months in Standardized Uptake Value Ratio (SUVr) for Posterior Cingulate Gyrus Region of the Brain Compared to Cerebellum
Description
SUVr is a measure of the amount of radiotracer activity bound to beta amyloid plaque in an individual region of brain tissue compared to radiotracer activity in the cerebellum, which is rarely involved by neuritic plaques. An elevated ratio >1.10 indicates a strong likelihood of significant underlying neuritic plaque burden. The percent change from baseline to 4-month scans in the posterior cingulate gyrus region is reported (percent change is calculated by subtracting baseline value from 4-month value; the result is then divided by the baseline value and multiplied by 100 to give a percentage). A positive number (percentage) indicates an increase in SUVr and more plaque burden in the posterior cingulate gyrus region, while a negative number (percentage) indicates a decrease in SUVr and a reduction in plaque burden in the posterior cingulate gyrus region.
Time Frame
Baseline to 4 months post-treatment
Title
Florbetaben F 18 Injection (AMYVID) Positron Emission Tomography (PET) Scan: Change From Baseline to 4 Months in Standardized Uptake Value Ratio (SUVr) for Whole Brain Cortex Compared to Cerebellum
Description
SUVr is a measure of the amount of radiotracer activity bound to beta amyloid plaque in an individual region of brain tissue compared to radiotracer activity in the cerebellum, which is rarely involved by neuritic plaques. An elevated ratio >1.10 indicates a strong likelihood of significant underlying neuritic plaque burden. The percent change from baseline to 4-month scans in the whole brain cortex relative to cerebellum is reported (percent change is calculated by subtracting baseline value from 4-month value; the result is then divided by the baseline value and multiplied by 100 to give a percentage). A positive number (percentage) indicates an increase in SUVr and more plaque burden in the whole brain cortex relative to cerebellum, while a negative number (percentage) indicates a decrease in SUVr and a reduction in plaque burden in the whole brain cortex relative to cerebellum.
Time Frame
Baseline to 4 months post-treatment
Title
Florbetaben F 18 Injection (AMYVID) Positron Emission Tomography (PET) Scan: Change From Baseline to 4 Months in Standardized Uptake Value Standard Deviation (SUV StdDev) From Normal Patients in SUVr Values for Frontal Region of the Brain
Description
The metric SUV StdDev from normal utilizes a database of age matched, cognitively normal individuals to compare the SUV ratios for individual regions of the brain. An elevated SUV StdDev > 1.65 indicates a strong likelihood of significant underlying neuritic plaque burden. The percent change from baseline to 4-month scans in the frontal region is reported (percent change is calculated by subtracting baseline value from 4-month value; the result is then divided by the baseline value and multiplied by 100 to give a percentage). A positive number indicates an increase in SUV StdDev and more plaque burden in the frontal region, while a negative number indicates a decrease in SUV StdDev and a reduction in plaque burden in the frontal region
Time Frame
Baseline to 4 months post-treatment
Title
Florbetaben F 18 Injection (AMYVID) Positron Emission Tomography (PET) Scan: Change From Baseline to 4 Months in Standardized Uptake Value Standard Deviation (SUV StdDev) From Normal Patients in SUVr Values for Parietal Region of the Brain
Description
The metric SUV StdDev from normal utilizes a database of age matched, cognitively normal individuals to compare the SUV ratios for individual regions of the brain. An elevated SUV StdDev > 1.65 indicates a strong likelihood of significant underlying neuritic plaque burden. The percent change from baseline to 4-month scans in the parietal region is reported (percent change is calculated by subtracting baseline value from 4-month value; the result is then divided by the baseline value and multiplied by 100 to give a percentage). A positive number indicates an increase in SUV StdDev and more plaque burden in the parietal region, while a negative number indicates a decrease in SUV StdDev and a reduction in plaque burden in the parietal region.
Time Frame
Baseline to 4 months post-treatment
Title
Florbetaben F 18 Injection (AMYVID) Positron Emission Tomography (PET) Scan: Change From Baseline to 4 Months in Standardized Uptake Value Standard Deviation (SUV StdDev) From Normal Patients in SUVr Values for Precuneus Region of the Brain
Description
The metric SUV StdDev from normal utilizes a database of age matched, cognitively normal individuals to compare the SUV ratios for individual regions of the brain. An elevated SUV StdDev > 1.65 indicates a strong likelihood of significant underlying neuritic plaque burden. The percent change from baseline to 4-month scans in the precuneus region is reported (percent change is calculated by subtracting baseline value from 4-month value; the result is then divided by the baseline value and multiplied by 100 to give a percentage). A positive number indicates an increase in SUV StdDev and more plaque burden in the precuneus region, while a negative number indicates a decrease in SUV StdDev and a reduction in plaque burden in the precuneus region.
Time Frame
Baseline to 4 months post-treatment
Title
Florbetaben F 18 Injection (AMYVID) Positron Emission Tomography (PET) Scan: Change From Baseline to 4 Months in Standardized Uptake Value Standard Deviation (SUV StdDev) From Normal Patients in SUVr Values for Anterior Cingulate Gyrus Region of the Brain
Description
The metric SUV StdDev from normal utilizes a database of age matched, cognitively normal individuals to compare the SUV ratios for individual regions of the brain. An elevated SUV StdDev > 1.65 indicates a strong likelihood of significant underlying neuritic plaque burden. The percent change from baseline to 4-month scans in the anterior cingulate gyrus region is reported (percent change is calculated by subtracting baseline value from 4-month value; the result is then divided by the baseline value and multiplied by 100 to give a percentage). A positive number indicates an increase in SUV StdDev and more plaque burden in the anterior cingulate gyrus region, while a negative number indicates a decrease in SUV StdDev and a reduction in plaque burden in the anterior cingulate gyrus region.
Time Frame
Baseline to 4 months post-treatment
Title
Florbetaben F 18 Injection (AMYVID) Positron Emission Tomography (PET) Scan: Change From Baseline to 4 Months in Standardized Uptake Value Standard Deviation (SUV StdDev) From Normal Patients in SUVr Values for Posterior Cingulate Gyrus Region of Brain
Description
The metric SUV StdDev from normal utilizes a database of age matched, cognitively normal individuals to compare the SUV ratios for individual regions of the brain. An elevated SUV StdDev > 1.65 indicates a strong likelihood of significant underlying neuritic plaque burden. The percent change from baseline to 4-month scans in the posterior cingulate gyrus region is reported (percent change is calculated by subtracting baseline value from 4-month value; the result is then divided by the baseline value and multiplied by 100 to give a percentage). A positive number indicates an increase in SUV StdDev and more plaque burden in the posterior cingulate gyrus region, while a negative number indicates a decrease in SUV StdDev and a reduction in plaque burden in the posterior cingulate gyrus region.
Time Frame
Baseline to 4 months post-treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Criteria for Eligibility (All responses must be YES)
Inclusion Criteria:
Patients must meet all eligibility criteria to be included in the study:
Must be 55 years of age or older
Patient must meet NINCDS-ADRDA criteria for Alzheimer's Disease
Patient must be able to complete Mini-Mental Examination (MMSE) and Alzheimer's Disease Assessment Scale - Cognitive (ADAS-Cog) questionnaire Score Sheets
Patient has a Rosen Modified Hachinski Ischemic Score of less than or equal to 4
Patient has a MMSE score of between 10-20
Patient has estimated survival of greater than 12 months
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:
The patient has a history of cancer except non-melanoma skin cancer
Patient is taking anti-epileptic medication.
Dermatological skin disease of the scalp
Patient taking Alzheimer medication within the last 3 months, i.e. Exelon, Aricept, Namenda, Reminyl or Ebixa.
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))
Patient currently participating in another Clinical Trial.
Patient and legally authorized representative unable to give informed consent
Patient with history of focal neurological deficits (with the exception of vibratory peripheral neuropathy)
Non-Alzheimer dementia
Patient has previous history of central nervous system radiation
Patient has evidence of substance abuse (alcohol / or other drugs of dependence) during previous 12 months
History of subdural hygroma / subdural hematoma
History of cerebral infection / hemorrhage.
History that the patient is immunocompromised
History of seizure activity
History of hydrocephalus
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Fontanesi, MD
Organizational Affiliation
William Beaumont Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beaumont Health
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48336
Country
United States
Facility Name
Beaumont Health
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study of Low Dose Whole Brain Irradiation in the Treatment of Alzheimer's Disease
We'll reach out to this number within 24 hrs