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Staffing and budget limitations. Administrative decision to halt enrollment due to coronavirus-19 (COVID) pandemic
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort One | Experimental | 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. |
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| Cohort Two | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5 daily fractions of 2 Gy | Radiation | Whole Brain Irradiation to treat Alzheimer's Disease |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 6 weeks post-treatment |
| 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. | Baseline 3 months post-treatment |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Criteria for Eligibility (All responses must be YES)
Inclusion Criteria:
Patients must meet all eligibility criteria to be included in the study:
Exclusion Criteria:
Patients will be excluded from the study if they meet any of the following criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James Fontanesi, MD | Corewell Health East | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beaumont Health | Farmington Hills | Michigan | 48336 | United States | ||
| Beaumont Health |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 5 daily fractions of 2 Gy: Whole Brain Irradiation to treat Alzheimer's Disease |
| FG001 | 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. 10 daily fractions of 2 Gy: Whole Brain Irradiation to treat Alzheimer's Disease |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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No enrollment in Cohort 2
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 5 daily fractions of 2 Gy: Whole Brain Irradiation to treat Alzheimer's Disease |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | No patients were enrolled in Cohort Two | Posted | Mean | Full Range | units on a scale | Baseline to 6 weeks post-treatment |
|
Adverse events were assessed over 12 months
No enrollment in Cohort 2
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 5 daily fractions of 2 Gy: Whole Brain Irradiation to treat Alzheimer's Disease |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| alopecia | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
Limited data was collected due to low enrollment influenced by the coronavirus-19 (COVID) pandemic. Some data was missing for some patients due to COVID restrictions on research. One patient withdrew from study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. James Fontanesi, Professor of Neurosurgery, Director of Radiation Oncology | William Beaumont Hospital | 947-521-8121 | james.fontanesi@beaumont.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 21, 2022 | Nov 29, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 18, 2020 | Nov 29, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Single group pilot study of radiation treatment. The two arms are sequential dose increase.
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| 10 daily fractions of 2 Gy |
| Radiation |
Whole Brain Irradiation to treat Alzheimer's Disease |
|
| 6 months post-treatment |
| 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. | Baseline to12 months post-treatment |
| Baseline to 4 months post-treatment |
| 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. | Baseline to 6 weeks post-treatment |
| 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. | Baseline to 3 months post-treatment |
| 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. | Baseline to 6 months post-treatment |
| 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. | Baseline to 12 months post-treatment |
| 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. | Baseline to 6 weeks post-treatment |
| 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. | Baseline to 3 months post-treatment |
| 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. | Baseline to 6 months post-treatment |
| 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. | Baseline to 12 months post-treatment |
| 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 | Baseline to 6 weeks post-treatment |
| 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. | Baseline to 3 months post-treatment |
| 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. | Baseline to 6 months post-treatment |
| 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. | Baseline to 12 months post-treatment |
| 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. | Baseline to 6 weeks post-treatment |
| 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. | Baseline to 3 months post-treatment |
| 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. | Baseline to 6 months post-treatment |
| 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. | 12 months post-treatment |
| 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. | Baseline to 4 months post-treatment |
| 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. | Baseline to 4 months post-treatment |
| 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. | Baseline to 4 months post-treatment |
| 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. | Baseline to 4 months post-treatment |
| 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. | Baseline to 4 months post-treatment |
| 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. | Baseline to 4 months post-treatment |
| 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 | Baseline to 4 months post-treatment |
| 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. | Baseline to 4 months post-treatment |
| 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. | Baseline to 4 months post-treatment |
| 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. | Baseline to 4 months post-treatment |
| 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. | Baseline to 4 months post-treatment |
| Royal Oak |
| Michigan |
| 48073 |
| United States |
| BG001 | 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. 10 daily fractions of 2 Gy: Whole Brain Irradiation to treat Alzheimer's Disease |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| OG000 |
| 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. 5 daily fractions of 2 Gy: Whole Brain Irradiation to treat Alzheimer's Disease |
| OG001 | 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. 10 daily fractions of 2 Gy: Whole Brain Irradiation to treat Alzheimer's Disease |
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| Primary | 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. | No patients were enrolled in Cohort Two | Posted | Mean | Full Range | units on a scale | Baseline 3 months post-treatment |
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| Primary | 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. | Due to patient withdrawal, only 1 patient in Cohort 1 had 6 month data. No patients enrolled in Cohort 2 | Posted | Mean | Full Range | units on a scale | 6 months post-treatment |
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| Primary | 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. | Due to patient withdrawal, only 1 patient with data at 12 months in Cohort 1. No enrollment in Cohort 2 | Posted | Mean | Full Range | units on a scale | Baseline to12 months post-treatment |
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| Secondary | 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. | No patients enrolled in second arm. | Posted | Count of Participants | Participants | Baseline to 4 months post-treatment |
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| Secondary | 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. | No enrollment in Cohort 2 | Posted | Mean | Full Range | units on a scale | Baseline to 6 weeks post-treatment |
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| Secondary | 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. | 1 patient in Cohort 1 did not complete 3 month MMSE. No enrollment in Cohort 2. | Posted | Mean | Full Range | units on a scale | Baseline to 3 months post-treatment |
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| Secondary | 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. | Due to patient withdrawal, MMSE data for only 1 patient in Cohort 1 available. No enrollment in Cohort 2 | Posted | Mean | Full Range | units on a scale | Baseline to 6 months post-treatment |
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| Secondary | 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. | No MMSE data for any patient in Cohort 1 available at 12 months. No enrollment in Cohort Two | Posted | Baseline to 12 months post-treatment |
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| Secondary | 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. | Data unavailable to any patient in Cohort 1. No patients were enrolled in Cohort 2. | Posted | Baseline to 6 weeks post-treatment |
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| Secondary | 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. | Data available for 1 patient in Cohort 1. No enrollment in Cohort 2 | Posted | Mean | Full Range | units on a scale | Baseline to 3 months post-treatment |
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| Secondary | 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. | No data available for patients in Cohort 1. No enrollment in Cohort 2 | Posted | Baseline to 6 months post-treatment |
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| Secondary | 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. | No data available for patients in Cohort 1. No enrollment in Cohort 2 | Posted | Baseline to 12 months post-treatment |
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| Secondary | 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 | No patients enrolled in Cohort 2. | Posted | Mean | Full Range | units on a scale | Baseline to 6 weeks post-treatment |
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| Secondary | 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. | Data available for only one patient in Cohort 1. No enrollment in Cohort 2 | Posted | Mean | Full Range | units on a scale | Baseline to 3 months post-treatment |
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| Secondary | 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. | Data available for only 1 patient in Cohort 1. No enrollment in Cohort 2 | Posted | Mean | Full Range | units on a scale | Baseline to 6 months post-treatment |
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| Secondary | 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. | No data available for any patients in Cohort 1. No enrollment in Cohort 2 | Posted | Baseline to 12 months post-treatment |
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| Secondary | 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. | No enrollment in Cohort 2. | Posted | Mean | Full Range | units on a scale | Baseline to 6 weeks post-treatment |
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| Secondary | 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. | Data available on 1 patient in Cohort 1. No enrollment in Cohort 2 | Posted | Mean | Full Range | units on a scale | Baseline to 3 months post-treatment |
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| Secondary | 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. | Data available for only 1 patient in Cohort 1. No enrollment in Cohort 2 | Posted | Mean | Full Range | units on a scale | Baseline to 6 months post-treatment |
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| Secondary | 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. | No data available for any patient in Cohort 1. No enrollment in Cohort 2 | Posted | 12 months post-treatment |
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| Secondary | 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. | No patients enrolled in second arm. | Posted | Mean | Full Range | percent change from baseline SUVr | Baseline to 4 months post-treatment |
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| Secondary | 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. | No patients enrolled in second arm. | Posted | Mean | Full Range | percent change from baseline SUVr | Baseline to 4 months post-treatment |
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| Secondary | 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. | No patients enrolled in second arm. | Posted | Mean | Full Range | percent change from baseline SUVr | Baseline to 4 months post-treatment |
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| Secondary | 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. | No patients enrolled in second arm. | Posted | Mean | Full Range | percent change from baseline SUVr | Baseline to 4 months post-treatment |
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| Secondary | 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. | No patients enrolled in second arm. | Posted | Mean | Full Range | percent change from baseline SUVr | Baseline to 4 months post-treatment |
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| Secondary | 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. | No patients enrolled in second arm. | Posted | Mean | Full Range | percent change from baseline SUVr | Baseline to 4 months post-treatment |
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| Secondary | 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 | No patients enrolled in second arm. | Posted | Mean | Full Range | percent change from baseline SUV StdDev | Baseline to 4 months post-treatment |
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| Secondary | 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. | No patients enrolled in second arm. | Posted | Mean | Full Range | percent change from baseline SUV StdDev | Baseline to 4 months post-treatment |
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| Secondary | 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. | No patients enrolled in second arm. | Posted | Mean | Full Range | percent change from baseline SUV StdDev | Baseline to 4 months post-treatment |
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| Secondary | 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. | No patients enrolled in second arm. | Posted | Mean | Full Range | percent change from baseline SUV StdDev | Baseline to 4 months post-treatment |
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| Secondary | 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. | No patients enrolled in second arm. | Posted | Mean | Full Range | percent change from baseline SUV StdDev | Baseline to 4 months post-treatment |
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| 1 |
| 2 |
| 0 |
| 2 |
| 2 |
| 2 |
| EG001 | 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. 10 daily fractions of 2 Gy: Whole Brain Irradiation to treat Alzheimer's Disease | 0 | 0 | 0 | 0 | 0 | 0 |
| fatigue | General disorders | CTCAE (5.0) | Systematic Assessment |
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Not provided
Not provided
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |