Trial Outcomes & Findings for Study of Low Dose Whole Brain Irradiation in the Treatment of Alzheimer's Disease (NCT NCT02359864)
NCT ID: NCT02359864
Last Updated: 2023-01-26
Results Overview
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.
TERMINATED
NA
2 participants
Baseline to 6 weeks post-treatment
2023-01-26
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
0
|
|
Overall Study
COMPLETED
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Study of Low Dose Whole Brain Irradiation in the Treatment of Alzheimer's Disease
Baseline characteristics by cohort
| Measure |
Cohort One
n=2 Participants
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
|
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
|
Total
n=2 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
74.5 years
n=5 Participants
|
—
|
74.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 6 weeks post-treatmentPopulation: No patients were enrolled in Cohort Two
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.
Outcome measures
| Measure |
Cohort One
n=2 Participants
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
|
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
|
|---|---|---|
|
Common Terminology Toxicity Criteria for Adverse Events (CTCAE) Version 5.0 - 6 Weeks
|
2 units on a scale
Interval 1.0 to 3.0
|
—
|
PRIMARY outcome
Timeframe: Baseline 3 months post-treatmentPopulation: No patients were enrolled in Cohort Two
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.
Outcome measures
| Measure |
Cohort One
n=2 Participants
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
|
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
|
|---|---|---|
|
Common Terminology Toxicity Criteria (CTCAE) Version 5.0 - 3 Months
|
1.5 units on a scale
Interval 0.0 to 3.0
|
—
|
PRIMARY outcome
Timeframe: 6 months post-treatmentPopulation: Due to patient withdrawal, only 1 patient in Cohort 1 had 6 month data. No patients enrolled in Cohort 2
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.
Outcome measures
| Measure |
Cohort One
n=1 Participants
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
|
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
|
|---|---|---|
|
Common Terminology Toxicity Criteria (Version 5.0) - 6 Months
|
0 units on a scale
Interval 0.0 to 0.0
|
—
|
PRIMARY outcome
Timeframe: Baseline to12 months post-treatmentPopulation: Due to patient withdrawal, only 1 patient with data at 12 months in Cohort 1. No enrollment in Cohort 2
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.
Outcome measures
| Measure |
Cohort One
n=1 Participants
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
|
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
|
|---|---|---|
|
Common Terminology Toxicity Criteria (Version 5.0) - 12 Months
|
0 units on a scale
Interval 0.0 to 0.0
|
—
|
SECONDARY outcome
Timeframe: Baseline to 4 months post-treatmentPopulation: No patients enrolled in second arm.
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.
Outcome measures
| Measure |
Cohort One
n=2 Participants
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
|
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
|
|---|---|---|
|
Florbetaben F 18 Injection (AMYVID) Positron Emission Tomography (PET) Scan: Change in "Positive" or "Negative" Determination
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline to 6 weeks post-treatmentPopulation: No enrollment in Cohort 2
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.
Outcome measures
| Measure |
Cohort One
n=2 Participants
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
|
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
|
|---|---|---|
|
Neurocognitive Function - MMSE (Mini Mental Status Exam) 6 Weeks Change From Baseline
|
1 units on a scale
Interval 0.0 to 2.0
|
—
|
SECONDARY outcome
Timeframe: Baseline to 3 months post-treatmentPopulation: 1 patient in Cohort 1 did not complete 3 month MMSE. No enrollment in Cohort 2.
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.
Outcome measures
| Measure |
Cohort One
n=1 Participants
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
|
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
|
|---|---|---|
|
Neurocognitive Function - MMSE (Mini Mental Status Exam) 3 Months Change From Baseline
|
-7 units on a scale
Interval -7.0 to -7.0
|
—
|
SECONDARY outcome
Timeframe: Baseline to 6 months post-treatmentPopulation: Due to patient withdrawal, MMSE data for only 1 patient in Cohort 1 available. No enrollment in Cohort 2
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.
Outcome measures
| Measure |
Cohort One
n=1 Participants
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
|
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
|
|---|---|---|
|
Neurocognitive Function - MMSE (Mini Mental Status Exam) 6 Months Change From Baseline
|
1 units on a scale
Interval 1.0 to 1.0
|
—
|
SECONDARY outcome
Timeframe: Baseline to 12 months post-treatmentPopulation: No MMSE data for any patient in Cohort 1 available at 12 months. No enrollment in Cohort Two
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 6 weeks post-treatmentPopulation: Data unavailable to any patient in Cohort 1. No patients were enrolled in Cohort 2.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 3 months post-treatmentPopulation: Data available for 1 patient in Cohort 1. No enrollment in Cohort 2
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.
Outcome measures
| Measure |
Cohort One
n=1 Participants
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
|
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
|
|---|---|---|
|
Neurocognitive Function - ADAS-Cog - 3 Months Change From Baseline
|
-14 units on a scale
Interval -14.0 to -14.0
|
—
|
SECONDARY outcome
Timeframe: Baseline to 6 months post-treatmentPopulation: No data available for patients in Cohort 1. No enrollment in Cohort 2
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 12 months post-treatmentPopulation: No data available for patients in Cohort 1. No enrollment in Cohort 2
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 6 weeks post-treatmentPopulation: No patients enrolled in Cohort 2.
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
Outcome measures
| Measure |
Cohort One
n=2 Participants
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
|
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
|
|---|---|---|
|
Neurocognitive Function - QOL-AD - 6 Weeks Change From Baseline
|
1.5 units on a scale
Interval -5.0 to 8.0
|
—
|
SECONDARY outcome
Timeframe: Baseline to 3 months post-treatmentPopulation: Data available for only one patient in Cohort 1. No enrollment in Cohort 2
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.
Outcome measures
| Measure |
Cohort One
n=1 Participants
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
|
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
|
|---|---|---|
|
Neurocognitive Function - QOL-AD - 3 Months Change From Baseline
|
-3 units on a scale
Interval -3.0 to -3.0
|
—
|
SECONDARY outcome
Timeframe: Baseline to 6 months post-treatmentPopulation: Data available for only 1 patient in Cohort 1. No enrollment in Cohort 2
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.
Outcome measures
| Measure |
Cohort One
n=1 Participants
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
|
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
|
|---|---|---|
|
Neurocognitive Function - QOL-AD - 6 Months Change From Baseline
|
-2 units on a scale
Interval -2.0 to -2.0
|
—
|
SECONDARY outcome
Timeframe: Baseline to 12 months post-treatmentPopulation: No data available for any patients in Cohort 1. No enrollment in Cohort 2
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 6 weeks post-treatmentPopulation: No enrollment in Cohort 2.
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.
Outcome measures
| Measure |
Cohort One
n=2 Participants
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
|
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
|
|---|---|---|
|
Neurocognitive Function - QUALID- 6 Weeks Change From Baseline
|
4 units on a scale
Interval -3.0 to 11.0
|
—
|
SECONDARY outcome
Timeframe: Baseline to 3 months post-treatmentPopulation: Data available on 1 patient in Cohort 1. No enrollment in Cohort 2
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.
Outcome measures
| Measure |
Cohort One
n=1 Participants
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
|
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
|
|---|---|---|
|
Neurocognitive Function - QUALID- 3 Months Change From Baseline
|
3 units on a scale
Interval 3.0 to 3.0
|
—
|
SECONDARY outcome
Timeframe: Baseline to 6 months post-treatmentPopulation: Data available for only 1 patient in Cohort 1. No enrollment in Cohort 2
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.
Outcome measures
| Measure |
Cohort One
n=1 Participants
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
|
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
|
|---|---|---|
|
Neurocognitive Function - QUALID- 6 Months Change From Baseline
|
0 units on a scale
Interval 0.0 to 0.0
|
—
|
SECONDARY outcome
Timeframe: 12 months post-treatmentPopulation: No data available for any patient in Cohort 1. No enrollment in Cohort 2
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 4 months post-treatmentPopulation: No patients enrolled in second arm.
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.
Outcome measures
| Measure |
Cohort One
n=2 Participants
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
|
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
|
|---|---|---|
|
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
|
22.7 percent change from baseline SUVr
Interval 15.3 to 30.1
|
—
|
SECONDARY outcome
Timeframe: Baseline to 4 months post-treatmentPopulation: No patients enrolled in second arm.
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.
Outcome measures
| Measure |
Cohort One
n=2 Participants
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
|
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
|
|---|---|---|
|
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
|
21.5 percent change from baseline SUVr
Interval 13.8 to 29.2
|
—
|
SECONDARY outcome
Timeframe: Baseline to 4 months post-treatmentPopulation: No patients enrolled in second arm.
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.
Outcome measures
| Measure |
Cohort One
n=2 Participants
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
|
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
|
|---|---|---|
|
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
|
24.0 percent change from baseline SUVr
Interval 15.0 to 33.1
|
—
|
SECONDARY outcome
Timeframe: Baseline to 4 months post-treatmentPopulation: No patients enrolled in second arm.
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.
Outcome measures
| Measure |
Cohort One
n=2 Participants
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
|
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
|
|---|---|---|
|
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
|
18.7 percent change from baseline SUVr
Interval 17.6 to 19.8
|
—
|
SECONDARY outcome
Timeframe: Baseline to 4 months post-treatmentPopulation: No patients enrolled in second arm.
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.
Outcome measures
| Measure |
Cohort One
n=2 Participants
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
|
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
|
|---|---|---|
|
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
|
21.3 percent change from baseline SUVr
Interval 18.7 to 23.9
|
—
|
SECONDARY outcome
Timeframe: Baseline to 4 months post-treatmentPopulation: No patients enrolled in second arm.
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.
Outcome measures
| Measure |
Cohort One
n=2 Participants
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
|
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
|
|---|---|---|
|
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
|
17.7 percent change from baseline SUVr
Interval 9.3 to 26.2
|
—
|
SECONDARY outcome
Timeframe: Baseline to 4 months post-treatmentPopulation: No patients enrolled in second arm.
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
Outcome measures
| Measure |
Cohort One
n=2 Participants
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
|
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
|
|---|---|---|
|
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
|
111.3 percent change from baseline SUV StdDev
Interval 90.3 to 132.3
|
—
|
SECONDARY outcome
Timeframe: Baseline to 4 months post-treatmentPopulation: No patients enrolled in second arm.
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.
Outcome measures
| Measure |
Cohort One
n=2 Participants
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
|
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
|
|---|---|---|
|
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
|
70.0 percent change from baseline SUV StdDev
Interval 63.2 to 76.7
|
—
|
SECONDARY outcome
Timeframe: Baseline to 4 months post-treatmentPopulation: No patients enrolled in second arm.
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.
Outcome measures
| Measure |
Cohort One
n=2 Participants
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
|
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
|
|---|---|---|
|
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
|
75.3 percent change from baseline SUV StdDev
Interval 59.4 to 91.2
|
—
|
SECONDARY outcome
Timeframe: Baseline to 4 months post-treatmentPopulation: No patients enrolled in second arm.
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.
Outcome measures
| Measure |
Cohort One
n=2 Participants
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
|
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
|
|---|---|---|
|
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
|
107.6 percent change from baseline SUV StdDev
Interval 77.5 to 137.6
|
—
|
SECONDARY outcome
Timeframe: Baseline to 4 months post-treatmentPopulation: No patients enrolled in second arm.
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.
Outcome measures
| Measure |
Cohort One
n=2 Participants
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
|
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
|
|---|---|---|
|
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
|
149.5 percent change from baseline SUV StdDev
Interval 60.1 to 238.9
|
—
|
Adverse Events
Cohort One
Cohort Two
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort One
n=2 participants at risk
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
|
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
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
alopecia
|
100.0%
2/2 • Number of events 2 • Adverse events were assessed over 12 months
No enrollment in Cohort 2
|
—
0/0 • Adverse events were assessed over 12 months
No enrollment in Cohort 2
|
|
General disorders
fatigue
|
50.0%
1/2 • Number of events 1 • Adverse events were assessed over 12 months
No enrollment in Cohort 2
|
—
0/0 • Adverse events were assessed over 12 months
No enrollment in Cohort 2
|
Additional Information
Dr. James Fontanesi, Professor of Neurosurgery, Director of Radiation Oncology
William Beaumont Hospital
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place