Trial Outcomes & Findings for Low Dose RT to Reduce Cerebral Amyloidosis in Early Alzheimer's (NCT NCT02769000)
NCT ID: NCT02769000
Last Updated: 2021-12-16
Results Overview
Evaluate the toxicity associated with the delivery of low dose fractionated whole brain irradiation in subjects with early Alzheimer's dementia using the CTCAE toxicity grading system. The scale is 0 - 5 with 0 being no toxicity and 5 being fatal.
TERMINATED
NA
5 participants
48 months
2021-12-16
Participant Flow
Participant milestones
| Measure |
Subjects 1-15
10 GY in 5 daily fractions: Subjects 1-15 10 GY in 5 daily fractions
|
Subjects 16 - 30
20 GY in 10 daily fractions: Subjects 16-30 20 GY in 10 daily fractions
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
0
|
|
Overall Study
COMPLETED
|
5
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Low Dose RT to Reduce Cerebral Amyloidosis in Early Alzheimer's
Baseline characteristics by cohort
| Measure |
Subjects 1-15
n=5 Participants
10 GY in 5 daily fractions: Subjects 1-15 10 GY in 5 daily fractions
|
Subjects 16 - 30
20 GY in 10 daily fractions: Subjects 16-30 20 GY in 10 daily fractions
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 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
|
5 participants
n=5 Participants
|
—
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 48 monthsEvaluate the toxicity associated with the delivery of low dose fractionated whole brain irradiation in subjects with early Alzheimer's dementia using the CTCAE toxicity grading system. The scale is 0 - 5 with 0 being no toxicity and 5 being fatal.
Outcome measures
| Measure |
Subjects 1-15
n=5 Participants
10 GY in 5 daily fractions: Subjects 1-15 10 GY in 5 daily fractions
|
|---|---|
|
Evaluate Toxicity Associated With Delivery of Low Dose Fractionated Whole Brain Irradiation in Subjects With Early Alzheimer's Dementia According to ADRDA Criteria.
Skin toxicity
|
2 grade of toxicity
Interval 0.0 to 2.0
|
|
Evaluate Toxicity Associated With Delivery of Low Dose Fractionated Whole Brain Irradiation in Subjects With Early Alzheimer's Dementia According to ADRDA Criteria.
Eye toxicity
|
0 grade of toxicity
Interval 0.0 to 2.0
|
|
Evaluate Toxicity Associated With Delivery of Low Dose Fractionated Whole Brain Irradiation in Subjects With Early Alzheimer's Dementia According to ADRDA Criteria.
Ear toxicity
|
0 grade of toxicity
Interval 0.0 to 2.0
|
|
Evaluate Toxicity Associated With Delivery of Low Dose Fractionated Whole Brain Irradiation in Subjects With Early Alzheimer's Dementia According to ADRDA Criteria.
Central Nervous System toxicity
|
2 grade of toxicity
Interval 2.0 to 3.0
|
|
Evaluate Toxicity Associated With Delivery of Low Dose Fractionated Whole Brain Irradiation in Subjects With Early Alzheimer's Dementia According to ADRDA Criteria.
Other toxicity
|
1 grade of toxicity
Interval 0.0 to 2.0
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Due to low power because of the small number of participants enrolled, change scores have not been calculated. Baseline and 12 month median scores and ranges are reported.
Patients will complete the Hopkins Verbal Learning Test-Revised (HVLT-R) which is a paper and pencil assessment. Overall scores will be reported. Scores range from 0 to 26 with higher scores indicating better functioning.
Outcome measures
| Measure |
Subjects 1-15
n=5 Participants
10 GY in 5 daily fractions: Subjects 1-15 10 GY in 5 daily fractions
|
|---|---|
|
Neurocognitive Function: Verbal Learning and Memory
Baseline
|
18 score on a scale
Interval 8.0 to 21.0
|
|
Neurocognitive Function: Verbal Learning and Memory
12 months
|
15 score on a scale
Interval 4.0 to 20.0
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Due to low power because of the small number of participants enrolled, change scores have not been calculated. Baseline and 12 month median scores and ranges are reported.
Patients will complete the Brief Visuospatial Memory Test-revised which is a paper and pencil assessment. Overall scores will be reported. Scores range from 0 to 36 with higher scores indicating better functioning.
Outcome measures
| Measure |
Subjects 1-15
n=5 Participants
10 GY in 5 daily fractions: Subjects 1-15 10 GY in 5 daily fractions
|
|---|---|
|
Neurocognitive Function: Visuospatial Memory
Baseline
|
12 score on a scale
Interval 5.0 to 17.0
|
|
Neurocognitive Function: Visuospatial Memory
12 months
|
10 score on a scale
Interval 4.0 to 22.0
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Due to low power because of the small number of participants enrolled, change scores have not been calculated. Baseline and 12 month median scores and ranges are reported.
Patients will complete the Mini-Mental State Exam (MMSE) which is an interview style assessment. Overall scores will be reported. Scores range from 0 to 30 with higher scores indicating better functioning.
Outcome measures
| Measure |
Subjects 1-15
n=5 Participants
10 GY in 5 daily fractions: Subjects 1-15 10 GY in 5 daily fractions
|
|---|---|
|
Neurocognitive Function: Cognitive Function
Baseline
|
25 score on a scale
Interval 22.0 to 25.0
|
|
Neurocognitive Function: Cognitive Function
12 months
|
26 score on a scale
Interval 13.0 to 29.0
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Due to low power because of the small number of participants enrolled, change scores have not been calculated. Baseline and 12 month median scores and ranges are reported.
Patients will complete the PHQ-9 (Patient Health Questionnaire-9) which is an interview style assessment. Overall scores will be reported. Scores range from 0 to 27 with lower scores indicting lower depression.
Outcome measures
| Measure |
Subjects 1-15
n=5 Participants
10 GY in 5 daily fractions: Subjects 1-15 10 GY in 5 daily fractions
|
|---|---|
|
Psychological Functioning: Depression
Baseline
|
2 score on a scale
Interval 0.0 to 2.0
|
|
Psychological Functioning: Depression
12 Months
|
3 score on a scale
Interval 1.0 to 8.0
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Due to low power because of the small number of participants enrolled, change scores have not been calculated. Baseline and 12 month median scores and ranges are reported.
Patients will complete the GAD-7 (General Anxiety Disorder-7) which is an interview style assessment. Overall scores will be reported. Scores range from 0 to 21 with lower scores indicating lower levels of anxiety.
Outcome measures
| Measure |
Subjects 1-15
n=5 Participants
10 GY in 5 daily fractions: Subjects 1-15 10 GY in 5 daily fractions
|
|---|---|
|
Psychological Functioning: Anxiety
Baseline
|
3 score on a scale
Interval 1.0 to 3.0
|
|
Psychological Functioning: Anxiety
12 Months
|
1 score on a scale
Interval 0.0 to 6.0
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Due to low power because of the small number of participants enrolled, change scores have not been calculated. Baseline and 12 month median scores and ranges are reported.
Patients will complete the Quality of Life in Alzheimer's Disease (QOL-AD) which is an interview style assessment. The QOL-AD is a 13-item questionnaire designed to provide both a patient and a caregiver report of the quality of life (QOL) for patients who have been diagnosed with Alzheimer Disease. Overall scores will be reported. Scores range from 13 to 52 with higher scores indicating better quality of life.
Outcome measures
| Measure |
Subjects 1-15
n=5 Participants
10 GY in 5 daily fractions: Subjects 1-15 10 GY in 5 daily fractions
|
|---|---|
|
Quality of Life in Alzheimer's Disease
Baseline
|
46 score on a scale
Interval 34.0 to 46.0
|
|
Quality of Life in Alzheimer's Disease
12 Months
|
40 score on a scale
Interval 39.0 to 46.0
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Due to low power because of the small number of participants enrolled, change scores have not been calculated. Baseline and 12 month median scores and ranges are reported.
Patients will complete the Everyday Cognition (ECog) which is an interview style assessment. Overall scores will be reported. Scores range from 39 to 156 with lower scores indicating less decline in cognition.
Outcome measures
| Measure |
Subjects 1-15
n=5 Participants
10 GY in 5 daily fractions: Subjects 1-15 10 GY in 5 daily fractions
|
|---|---|
|
Cognitive and Functional Decline
Baseline
|
66 score on a scale
Interval 45.0 to 72.0
|
|
Cognitive and Functional Decline
12 Months
|
64 score on a scale
Interval 32.0 to 88.0
|
Adverse Events
Subjects 1-15
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place