Trial Outcomes & Findings for Rasagiline Rescue in Alzheimer's Disease Clinical Trial (NCT NCT02359552)
NCT ID: NCT02359552
Last Updated: 2020-11-10
Results Overview
The primary outcome measure is the change from baseline to week 24 in FDG-PET as measured by Standard Uptake Units Regional (SUVR) in several pre-specified brain regions including the medial temporal, lateral temporal, posterior cingulate - precuneus, inferior parietal, middle frontal, anterior cingulate, and striatum. The SUVR change was calculated by subtracting the value at 24 weeks from baseline values. Negative values indicate increased hypometabolism (i.e. worsening of cell function).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
24 weeks
Results posted on
2020-11-10
Participant Flow
Patients were recruited based on physician referral from three Cleveland Clinic sites between May 2015 and January 2018
Of 96 screened participants, 50 met inclusion criteria and were enrolled and randomized to treatment.
Participant milestones
| Measure |
Placebo
Subjects will be randomized in 1:1 ratio to receive Rasagiline or the matching placebo 24-week double blind treatment.
Subjects will take one 0.5 mg Rasagiline tablet or the matching placebo once a day on Baseline (Day 1) through Week 4. The dose will be titrated up to one 1 mg tablet or the matching placebo once a day starting on Week 5 until the Week 28 (end of treatment visit).
Placebo
|
Rasagiline
Subjects will be randomized in 1:1 ratio to receive Rasagiline or the matching placebo 24-week double blind treatment.
Subjects will take one 0.5 mg Rasagiline tablet or the matching placebo once a day on Baseline (Day 1) through Week 4. The dose will be titrated up to one 1 mg tablet or the matching placebo once a day starting on Week 5 until the Week 28 (end of treatment visit).
Rasagiline
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
22
|
21
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
Reasons for withdrawal
| Measure |
Placebo
Subjects will be randomized in 1:1 ratio to receive Rasagiline or the matching placebo 24-week double blind treatment.
Subjects will take one 0.5 mg Rasagiline tablet or the matching placebo once a day on Baseline (Day 1) through Week 4. The dose will be titrated up to one 1 mg tablet or the matching placebo once a day starting on Week 5 until the Week 28 (end of treatment visit).
Placebo
|
Rasagiline
Subjects will be randomized in 1:1 ratio to receive Rasagiline or the matching placebo 24-week double blind treatment.
Subjects will take one 0.5 mg Rasagiline tablet or the matching placebo once a day on Baseline (Day 1) through Week 4. The dose will be titrated up to one 1 mg tablet or the matching placebo once a day starting on Week 5 until the Week 28 (end of treatment visit).
Rasagiline
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
4
|
Baseline Characteristics
Rasagiline Rescue in Alzheimer's Disease Clinical Trial
Baseline characteristics by cohort
| Measure |
Placebo
n=25 Participants
Subjects will be randomized in 1:1 ratio to receive Rasagiline or the matching placebo 24-week double blind treatment.
Subjects will take one 0.5 mg Rasagiline tablet or the matching placebo once a day on Baseline (Day 1) through Week 4. The dose will be titrated up to one 1 mg tablet or the matching placebo once a day starting on Week 5 until the Week 28 (end of treatment visit).
Placebo
|
Rasagiline
n=25 Participants
Subjects will be randomized in 1:1 ratio to receive Rasagiline or the matching placebo 24-week double blind treatment.
Subjects will take one 0.5 mg Rasagiline tablet or the matching placebo once a day on Baseline (Day 1) through Week 4. The dose will be titrated up to one 1 mg tablet or the matching placebo once a day starting on Week 5 until the Week 28 (end of treatment visit).
Rasagiline
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
73.44 years
STANDARD_DEVIATION 7.12 • n=5 Participants
|
74.72 years
STANDARD_DEVIATION 7.35 • n=7 Participants
|
74.08 years
STANDARD_DEVIATION 7.19 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
25 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
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
50 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
|
1 Participants
n=7 Participants
|
1 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
48 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
|
25 participants
n=5 Participants
|
25 participants
n=7 Participants
|
50 participants
n=5 Participants
|
|
Alzheimer's Disease Assessment Scale - Cognitive 11 score
|
27.96 units on a scale
STANDARD_DEVIATION 10.53 • n=5 Participants
|
23.2 units on a scale
STANDARD_DEVIATION 6 • n=7 Participants
|
25.58 units on a scale
STANDARD_DEVIATION 8.81 • n=5 Participants
|
|
Mini Mental Status Examination (MMSE)
|
19.04 units on a scale
STANDARD_DEVIATION 4.61 • n=5 Participants
|
21.24 units on a scale
STANDARD_DEVIATION 3.54 • n=7 Participants
|
20.14 units on a scale
STANDARD_DEVIATION 4.21 • n=5 Participants
|
|
Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) score
|
58.2 units on a scale
STANDARD_DEVIATION 11.1 • n=5 Participants
|
61.88 units on a scale
STANDARD_DEVIATION 8.44 • n=7 Participants
|
60 units on a scale
STANDARD_DEVIATION 9.96 • n=5 Participants
|
|
Neuropsychiatric Inventory (NPI) score
|
8.28 units on a scale
STANDARD_DEVIATION 8.97 • n=5 Participants
|
7.62 units on a scale
STANDARD_DEVIATION 7.61 • n=7 Participants
|
7.96 units on a scale
STANDARD_DEVIATION 8.25 • n=5 Participants
|
|
digit span
|
11.76 units on a scale
STANDARD_DEVIATION 3.23 • n=5 Participants
|
13.08 units on a scale
STANDARD_DEVIATION 2.75 • n=7 Participants
|
12.42 units on a scale
STANDARD_DEVIATION 3.04 • n=5 Participants
|
|
Controlled Oral Word Association Test (cowat) score
|
21.16 units on a scale
STANDARD_DEVIATION 13.16 • n=5 Participants
|
26.72 units on a scale
STANDARD_DEVIATION 12.6 • n=7 Participants
|
23.94 units on a scale
STANDARD_DEVIATION 13.06 • n=5 Participants
|
|
Quality of Life - Alzheimer's Disease (QoL-AD)
|
39.58 units on a scale
STANDARD_DEVIATION 5.24 • n=5 Participants
|
36.73 units on a scale
STANDARD_DEVIATION 5.35 • n=7 Participants
|
38.22 units on a scale
STANDARD_DEVIATION 5.43 • n=5 Participants
|
PRIMARY outcome
Timeframe: 24 weeksThe primary outcome measure is the change from baseline to week 24 in FDG-PET as measured by Standard Uptake Units Regional (SUVR) in several pre-specified brain regions including the medial temporal, lateral temporal, posterior cingulate - precuneus, inferior parietal, middle frontal, anterior cingulate, and striatum. The SUVR change was calculated by subtracting the value at 24 weeks from baseline values. Negative values indicate increased hypometabolism (i.e. worsening of cell function).
Outcome measures
| Measure |
Placebo
n=25 Participants
Subjects will be randomized in 1:1 ratio to receive Rasagiline or the matching placebo 24-week double blind treatment.
Subjects will take one 0.5 mg Rasagiline tablet or the matching placebo once a day on Baseline (Day 1) through Week 4. The dose will be titrated up to one 1 mg tablet or the matching placebo once a day starting on Week 5 until the Week 28 (end of treatment visit).
Placebo
|
Rasagiline
n=25 Participants
Subjects will be randomized in 1:1 ratio to receive Rasagiline or the matching placebo 24-week double blind treatment.
Subjects will take one 0.5 mg Rasagiline tablet or the matching placebo once a day on Baseline (Day 1) through Week 4. The dose will be titrated up to one 1 mg tablet or the matching placebo once a day starting on Week 5 until the Week 28 (end of treatment visit).
Rasagiline
|
|---|---|---|
|
Change in Regional Glucose Metabolism Between Week 24 and Baseline as Measured by 18F-2-fluoro-2-deoxy-D-glucose Positron Emission Tomography (FDG-PET).
Middle Frontal
|
-0.032 SUVR
Standard Deviation 0.030
|
-0.011 SUVR
Standard Deviation 0.030
|
|
Change in Regional Glucose Metabolism Between Week 24 and Baseline as Measured by 18F-2-fluoro-2-deoxy-D-glucose Positron Emission Tomography (FDG-PET).
Anterior Cingulate
|
-0.020 SUVR
Standard Deviation 0.021
|
-0.003 SUVR
Standard Deviation 0.026
|
|
Change in Regional Glucose Metabolism Between Week 24 and Baseline as Measured by 18F-2-fluoro-2-deoxy-D-glucose Positron Emission Tomography (FDG-PET).
Superior Frontal
|
-0.016 SUVR
Standard Deviation 0.022
|
-0.003 SUVR
Standard Deviation 0.018
|
|
Change in Regional Glucose Metabolism Between Week 24 and Baseline as Measured by 18F-2-fluoro-2-deoxy-D-glucose Positron Emission Tomography (FDG-PET).
Striatum
|
-0.024 SUVR
Standard Deviation 0.029
|
-0.002 SUVR
Standard Deviation 0.028
|
|
Change in Regional Glucose Metabolism Between Week 24 and Baseline as Measured by 18F-2-fluoro-2-deoxy-D-glucose Positron Emission Tomography (FDG-PET).
Medial Temporal
|
-0.015 SUVR
Standard Deviation 0.034
|
-0.010 SUVR
Standard Deviation 0.034
|
|
Change in Regional Glucose Metabolism Between Week 24 and Baseline as Measured by 18F-2-fluoro-2-deoxy-D-glucose Positron Emission Tomography (FDG-PET).
Lateral Temporal
|
-0.020 SUVR
Standard Deviation 0.029
|
-0.016 SUVR
Standard Deviation 0.024
|
|
Change in Regional Glucose Metabolism Between Week 24 and Baseline as Measured by 18F-2-fluoro-2-deoxy-D-glucose Positron Emission Tomography (FDG-PET).
Post Cingulate - Precuneus
|
-0.017 SUVR
Standard Deviation 0.023
|
-0.016 SUVR
Standard Deviation 0.018
|
|
Change in Regional Glucose Metabolism Between Week 24 and Baseline as Measured by 18F-2-fluoro-2-deoxy-D-glucose Positron Emission Tomography (FDG-PET).
Inferior Parietal
|
-0.025 SUVR
Standard Deviation 0.029
|
-0.018 SUVR
Standard Deviation 0.022
|
SECONDARY outcome
Timeframe: Mean change in scores from baseline to week 24The ADAS-Cog 11 (Alzheimer's Disease Assessment Scale - Cognitive 11) is a psychometric instrument that evaluates memory, attention, reasoning, language, orientation, and praxis. A higher score indicates more impairment. Scores from the original portion of the test range from 0 (best) to 70 (worse). We used total ADAS-Cog 11 scores, which is a sum of individual subscales. We calculated the change by subtracting the ADAS Cog score at week 24 from baseline score. A positive change indicates cognitive worsening.
Outcome measures
| Measure |
Placebo
n=25 Participants
Subjects will be randomized in 1:1 ratio to receive Rasagiline or the matching placebo 24-week double blind treatment.
Subjects will take one 0.5 mg Rasagiline tablet or the matching placebo once a day on Baseline (Day 1) through Week 4. The dose will be titrated up to one 1 mg tablet or the matching placebo once a day starting on Week 5 until the Week 28 (end of treatment visit).
Placebo
|
Rasagiline
n=25 Participants
Subjects will be randomized in 1:1 ratio to receive Rasagiline or the matching placebo 24-week double blind treatment.
Subjects will take one 0.5 mg Rasagiline tablet or the matching placebo once a day on Baseline (Day 1) through Week 4. The dose will be titrated up to one 1 mg tablet or the matching placebo once a day starting on Week 5 until the Week 28 (end of treatment visit).
Rasagiline
|
|---|---|---|
|
Change in ADAS-Cog 11 (Alzheimer's Disease Assessment Scale - Cognitive 11) Score
|
2.76 score on a scale
Standard Deviation 4.3
|
1.81 score on a scale
Standard Deviation 4.43
|
SECONDARY outcome
Timeframe: Mean change in scores from baseline to week 24Measure Description: The MMSE (Mini Mental Status Examination) is a brief, frequently used screening instrument for AD drug studies. The MMSE evaluates orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two overlapping pentagons. A lower score indicates more cognitive impairment. The highest score is 30, range is between 0 (severe impairment) and 30 (cognitively normal). We calculated the change in scores by subtracting week 24 score from baseline. A negative score indicates clinical worsening.
Outcome measures
| Measure |
Placebo
n=25 Participants
Subjects will be randomized in 1:1 ratio to receive Rasagiline or the matching placebo 24-week double blind treatment.
Subjects will take one 0.5 mg Rasagiline tablet or the matching placebo once a day on Baseline (Day 1) through Week 4. The dose will be titrated up to one 1 mg tablet or the matching placebo once a day starting on Week 5 until the Week 28 (end of treatment visit).
Placebo
|
Rasagiline
n=25 Participants
Subjects will be randomized in 1:1 ratio to receive Rasagiline or the matching placebo 24-week double blind treatment.
Subjects will take one 0.5 mg Rasagiline tablet or the matching placebo once a day on Baseline (Day 1) through Week 4. The dose will be titrated up to one 1 mg tablet or the matching placebo once a day starting on Week 5 until the Week 28 (end of treatment visit).
Rasagiline
|
|---|---|---|
|
Change in MMSE (Mini Mental Status Examination) Score
|
-1.14 score on a scale
Standard Deviation 2.27
|
-0.65 score on a scale
Standard Deviation 2.48
|
SECONDARY outcome
Timeframe: Mean change in scores from baseline to week 24Measure Description: The ADCS-ADL (Alzheimer's Disease Cooperative Study-Activities of Daily Living) is an activities-of-daily-living inventory developed by the ADCS to assess functional performance in participants with AD. Using a structured interview format, study partners are queried as to whether participants attempted each item in the inventory during the past 4 weeks and their level of performance. The ADCS-ADL provides a total score from 0-78, with a lower score indicating greater severity. We calculated change by subtracting scores on week 24 test from the baseline score. A negative score indicates worsening ability to complete ADLs.
Outcome measures
| Measure |
Placebo
n=25 Participants
Subjects will be randomized in 1:1 ratio to receive Rasagiline or the matching placebo 24-week double blind treatment.
Subjects will take one 0.5 mg Rasagiline tablet or the matching placebo once a day on Baseline (Day 1) through Week 4. The dose will be titrated up to one 1 mg tablet or the matching placebo once a day starting on Week 5 until the Week 28 (end of treatment visit).
Placebo
|
Rasagiline
n=25 Participants
Subjects will be randomized in 1:1 ratio to receive Rasagiline or the matching placebo 24-week double blind treatment.
Subjects will take one 0.5 mg Rasagiline tablet or the matching placebo once a day on Baseline (Day 1) through Week 4. The dose will be titrated up to one 1 mg tablet or the matching placebo once a day starting on Week 5 until the Week 28 (end of treatment visit).
Rasagiline
|
|---|---|---|
|
Change in ADCS-ADL (Alzheimer's Disease Cooperative Study-Activities of Daily Living) Score
|
-3.23 score on a scale
Standard Deviation 6.71
|
-3.75 score on a scale
Standard Deviation 7.27
|
SECONDARY outcome
Timeframe: Mean change in scores from baseline to week 24Measure Description: The behavioral outcome measure for this trial is the NPI (Neuropsychiatric Inventory). The NPI evaluates both the frequency and severity of 10 neuropsychiatric disturbances. Frequency assessments range from 1 (occasionally, less than once per week) to 4 (very frequently, once or more per day or continuously) as well as severity (1=mild, 2=moderate, 3=severe). The overall score is calculated by summing the severity and frequency of the subscale measures. The range of scores is 0-40. A score of 0 indicates no behavioral impairment and a score of 40 indicates severe behavioral impairment. We calculated change by subtracting Week 24 scores from baseline scores. A positive change indicates behavioral worsening.
Outcome measures
| Measure |
Placebo
n=25 Participants
Subjects will be randomized in 1:1 ratio to receive Rasagiline or the matching placebo 24-week double blind treatment.
Subjects will take one 0.5 mg Rasagiline tablet or the matching placebo once a day on Baseline (Day 1) through Week 4. The dose will be titrated up to one 1 mg tablet or the matching placebo once a day starting on Week 5 until the Week 28 (end of treatment visit).
Placebo
|
Rasagiline
n=25 Participants
Subjects will be randomized in 1:1 ratio to receive Rasagiline or the matching placebo 24-week double blind treatment.
Subjects will take one 0.5 mg Rasagiline tablet or the matching placebo once a day on Baseline (Day 1) through Week 4. The dose will be titrated up to one 1 mg tablet or the matching placebo once a day starting on Week 5 until the Week 28 (end of treatment visit).
Rasagiline
|
|---|---|---|
|
Change in NPI (Neuropsychiatric Inventory) Score
|
2 score on a scale
Standard Deviation 7.18
|
0.2 score on a scale
Standard Deviation 6.79
|
SECONDARY outcome
Timeframe: Mean change in scores from baseline to week 24Measure Description: The Digit Span consists of repetition of increasing long strings of digits presented at 1 per second as read by the examiner and repeated by the subject.The score is the maximum number of digits the patient can repeat until they fail twice in a row. The reverse digit span is identical to the forward digit span except that the patient repeats the presented digits in reverse order. The score is the maximum number of digits the patient can repeat in reverse order until they fail twice in a row. Each correct response is worth one point with a maximum total score of 28. A higher score is better. We calculated change by subtracting week 24 score from baseline score. A negative score indicates worse performance over the course of study.
Outcome measures
| Measure |
Placebo
n=25 Participants
Subjects will be randomized in 1:1 ratio to receive Rasagiline or the matching placebo 24-week double blind treatment.
Subjects will take one 0.5 mg Rasagiline tablet or the matching placebo once a day on Baseline (Day 1) through Week 4. The dose will be titrated up to one 1 mg tablet or the matching placebo once a day starting on Week 5 until the Week 28 (end of treatment visit).
Placebo
|
Rasagiline
n=25 Participants
Subjects will be randomized in 1:1 ratio to receive Rasagiline or the matching placebo 24-week double blind treatment.
Subjects will take one 0.5 mg Rasagiline tablet or the matching placebo once a day on Baseline (Day 1) through Week 4. The dose will be titrated up to one 1 mg tablet or the matching placebo once a day starting on Week 5 until the Week 28 (end of treatment visit).
Rasagiline
|
|---|---|---|
|
Change in Digit Span
|
-1.18 score on a scale
Standard Deviation 1.92
|
-0.29 score on a scale
Standard Deviation 3.08
|
SECONDARY outcome
Timeframe: Mean change in scores from baseline to week 24Measure Description: Study participants are instructed, "I want to see how many words you can say beginning with a certain letter in one minute." The study participant's responses are recorded on the worksheet. Study participants are then given an additional one minute for each of two different letters using similar instructions. The score is the total number of acceptable words for the three trials combined. A higher score represents better performance. Responses are then judged for their acceptability (example for the use of proper nouns, numbers, repetitions and stem word with a different ending). The score is the total number of acceptable words for the three trials combined. A higher score represents better performance. We calculated change by subtracting week 24 scores from baseline scores. A negative score indicates worse performance.
Outcome measures
| Measure |
Placebo
n=25 Participants
Subjects will be randomized in 1:1 ratio to receive Rasagiline or the matching placebo 24-week double blind treatment.
Subjects will take one 0.5 mg Rasagiline tablet or the matching placebo once a day on Baseline (Day 1) through Week 4. The dose will be titrated up to one 1 mg tablet or the matching placebo once a day starting on Week 5 until the Week 28 (end of treatment visit).
Placebo
|
Rasagiline
n=25 Participants
Subjects will be randomized in 1:1 ratio to receive Rasagiline or the matching placebo 24-week double blind treatment.
Subjects will take one 0.5 mg Rasagiline tablet or the matching placebo once a day on Baseline (Day 1) through Week 4. The dose will be titrated up to one 1 mg tablet or the matching placebo once a day starting on Week 5 until the Week 28 (end of treatment visit).
Rasagiline
|
|---|---|---|
|
Change in COWAT (Controlled Oral Word Association Test) Score
|
-1.09 score on a scale
Standard Deviation 6.31
|
0.62 score on a scale
Standard Deviation 5.55
|
SECONDARY outcome
Timeframe: This assessment will be performed at the Baseline and Week 24 visits.Measure Description: The QoL-AD (Quality of Life - Alzheimer's Disease) is a commonly used 13 item QoL scale that assesses items specific to QoL in patients with cognitive impairment. It is administered to the research partner with answers for the patient. Points are assigned to each item as follows: poor = 1, fair = 2, good = 3, excellent = 4.The total score is the sum of all 13 items. The range of score is from 0-52. We calculated the change by subtracting the scores on week 24 score from baseline. A negative value indicates worsening quality of life.
Outcome measures
| Measure |
Placebo
n=25 Participants
Subjects will be randomized in 1:1 ratio to receive Rasagiline or the matching placebo 24-week double blind treatment.
Subjects will take one 0.5 mg Rasagiline tablet or the matching placebo once a day on Baseline (Day 1) through Week 4. The dose will be titrated up to one 1 mg tablet or the matching placebo once a day starting on Week 5 until the Week 28 (end of treatment visit).
Placebo
|
Rasagiline
n=25 Participants
Subjects will be randomized in 1:1 ratio to receive Rasagiline or the matching placebo 24-week double blind treatment.
Subjects will take one 0.5 mg Rasagiline tablet or the matching placebo once a day on Baseline (Day 1) through Week 4. The dose will be titrated up to one 1 mg tablet or the matching placebo once a day starting on Week 5 until the Week 28 (end of treatment visit).
Rasagiline
|
|---|---|---|
|
Change in QoL-AD (Quality of Life - Alzheimer's Disease) Score
|
-1.95 score on a scale
Standard Deviation 3.28
|
1.11 score on a scale
Standard Deviation 3.77
|
Adverse Events
Placebo
Serious events: 4 serious events
Other events: 15 other events
Deaths: 0 deaths
Rasagiline
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=25 participants at risk
Subjects will be randomized in 1:1 ratio to receive Rasagiline or the matching placebo 24-week double blind treatment.
Subjects will take one 0.5 mg Rasagiline tablet or the matching placebo once a day on Baseline (Day 1) through Week 4. The dose will be titrated up to one 1 mg tablet or the matching placebo once a day starting on Week 5 until the Week 28 (end of treatment visit).
Placebo
|
Rasagiline
n=25 participants at risk
Subjects will be randomized in 1:1 ratio to receive Rasagiline or the matching placebo 24-week double blind treatment.
Subjects will take one 0.5 mg Rasagiline tablet or the matching placebo once a day on Baseline (Day 1) through Week 4. The dose will be titrated up to one 1 mg tablet or the matching placebo once a day starting on Week 5 until the Week 28 (end of treatment visit).
Rasagiline
|
|---|---|---|
|
Psychiatric disorders
confusion
|
4.0%
1/25 • Number of events 1 • Adverse event data were collected following signing of consent to completion of study week 28 (from May 2016 to August 2018). At each point of contact the research coordinator and PI collected data regarding any new symptoms or laboratory changes.
|
0.00%
0/25 • Adverse event data were collected following signing of consent to completion of study week 28 (from May 2016 to August 2018). At each point of contact the research coordinator and PI collected data regarding any new symptoms or laboratory changes.
|
|
Psychiatric disorders
delusions
|
4.0%
1/25 • Number of events 1 • Adverse event data were collected following signing of consent to completion of study week 28 (from May 2016 to August 2018). At each point of contact the research coordinator and PI collected data regarding any new symptoms or laboratory changes.
|
0.00%
0/25 • Adverse event data were collected following signing of consent to completion of study week 28 (from May 2016 to August 2018). At each point of contact the research coordinator and PI collected data regarding any new symptoms or laboratory changes.
|
|
Cardiac disorders
atrial fibrillation
|
0.00%
0/25 • Adverse event data were collected following signing of consent to completion of study week 28 (from May 2016 to August 2018). At each point of contact the research coordinator and PI collected data regarding any new symptoms or laboratory changes.
|
4.0%
1/25 • Number of events 1 • Adverse event data were collected following signing of consent to completion of study week 28 (from May 2016 to August 2018). At each point of contact the research coordinator and PI collected data regarding any new symptoms or laboratory changes.
|
|
Injury, poisoning and procedural complications
fall
|
4.0%
1/25 • Number of events 1 • Adverse event data were collected following signing of consent to completion of study week 28 (from May 2016 to August 2018). At each point of contact the research coordinator and PI collected data regarding any new symptoms or laboratory changes.
|
0.00%
0/25 • Adverse event data were collected following signing of consent to completion of study week 28 (from May 2016 to August 2018). At each point of contact the research coordinator and PI collected data regarding any new symptoms or laboratory changes.
|
|
Nervous system disorders
stroke
|
4.0%
1/25 • Number of events 1 • Adverse event data were collected following signing of consent to completion of study week 28 (from May 2016 to August 2018). At each point of contact the research coordinator and PI collected data regarding any new symptoms or laboratory changes.
|
0.00%
0/25 • Adverse event data were collected following signing of consent to completion of study week 28 (from May 2016 to August 2018). At each point of contact the research coordinator and PI collected data regarding any new symptoms or laboratory changes.
|
Other adverse events
| Measure |
Placebo
n=25 participants at risk
Subjects will be randomized in 1:1 ratio to receive Rasagiline or the matching placebo 24-week double blind treatment.
Subjects will take one 0.5 mg Rasagiline tablet or the matching placebo once a day on Baseline (Day 1) through Week 4. The dose will be titrated up to one 1 mg tablet or the matching placebo once a day starting on Week 5 until the Week 28 (end of treatment visit).
Placebo
|
Rasagiline
n=25 participants at risk
Subjects will be randomized in 1:1 ratio to receive Rasagiline or the matching placebo 24-week double blind treatment.
Subjects will take one 0.5 mg Rasagiline tablet or the matching placebo once a day on Baseline (Day 1) through Week 4. The dose will be titrated up to one 1 mg tablet or the matching placebo once a day starting on Week 5 until the Week 28 (end of treatment visit).
Rasagiline
|
|---|---|---|
|
Renal and urinary disorders
Abnormal UA
|
4.0%
1/25 • Number of events 1 • Adverse event data were collected following signing of consent to completion of study week 28 (from May 2016 to August 2018). At each point of contact the research coordinator and PI collected data regarding any new symptoms or laboratory changes.
|
8.0%
2/25 • Number of events 2 • Adverse event data were collected following signing of consent to completion of study week 28 (from May 2016 to August 2018). At each point of contact the research coordinator and PI collected data regarding any new symptoms or laboratory changes.
|
|
Psychiatric disorders
Agitation
|
8.0%
2/25 • Number of events 2 • Adverse event data were collected following signing of consent to completion of study week 28 (from May 2016 to August 2018). At each point of contact the research coordinator and PI collected data regarding any new symptoms or laboratory changes.
|
0.00%
0/25 • Adverse event data were collected following signing of consent to completion of study week 28 (from May 2016 to August 2018). At each point of contact the research coordinator and PI collected data regarding any new symptoms or laboratory changes.
|
|
Psychiatric disorders
Confusion
|
8.0%
2/25 • Number of events 2 • Adverse event data were collected following signing of consent to completion of study week 28 (from May 2016 to August 2018). At each point of contact the research coordinator and PI collected data regarding any new symptoms or laboratory changes.
|
8.0%
2/25 • Number of events 2 • Adverse event data were collected following signing of consent to completion of study week 28 (from May 2016 to August 2018). At each point of contact the research coordinator and PI collected data regarding any new symptoms or laboratory changes.
|
|
Psychiatric disorders
Delusions
|
12.0%
3/25 • Number of events 3 • Adverse event data were collected following signing of consent to completion of study week 28 (from May 2016 to August 2018). At each point of contact the research coordinator and PI collected data regarding any new symptoms or laboratory changes.
|
12.0%
3/25 • Number of events 3 • Adverse event data were collected following signing of consent to completion of study week 28 (from May 2016 to August 2018). At each point of contact the research coordinator and PI collected data regarding any new symptoms or laboratory changes.
|
|
Vascular disorders
Elevated blood pressure
|
8.0%
2/25 • Number of events 2 • Adverse event data were collected following signing of consent to completion of study week 28 (from May 2016 to August 2018). At each point of contact the research coordinator and PI collected data regarding any new symptoms or laboratory changes.
|
12.0%
3/25 • Number of events 3 • Adverse event data were collected following signing of consent to completion of study week 28 (from May 2016 to August 2018). At each point of contact the research coordinator and PI collected data regarding any new symptoms or laboratory changes.
|
|
Endocrine disorders
Elevated Thyroid Stimulating Hormone
|
4.0%
1/25 • Number of events 1 • Adverse event data were collected following signing of consent to completion of study week 28 (from May 2016 to August 2018). At each point of contact the research coordinator and PI collected data regarding any new symptoms or laboratory changes.
|
8.0%
2/25 • Number of events 2 • Adverse event data were collected following signing of consent to completion of study week 28 (from May 2016 to August 2018). At each point of contact the research coordinator and PI collected data regarding any new symptoms or laboratory changes.
|
|
Injury, poisoning and procedural complications
Fall
|
4.0%
1/25 • Number of events 1 • Adverse event data were collected following signing of consent to completion of study week 28 (from May 2016 to August 2018). At each point of contact the research coordinator and PI collected data regarding any new symptoms or laboratory changes.
|
8.0%
2/25 • Number of events 2 • Adverse event data were collected following signing of consent to completion of study week 28 (from May 2016 to August 2018). At each point of contact the research coordinator and PI collected data regarding any new symptoms or laboratory changes.
|
|
Psychiatric disorders
Insomnia
|
8.0%
2/25 • Number of events 2 • Adverse event data were collected following signing of consent to completion of study week 28 (from May 2016 to August 2018). At each point of contact the research coordinator and PI collected data regarding any new symptoms or laboratory changes.
|
0.00%
0/25 • Adverse event data were collected following signing of consent to completion of study week 28 (from May 2016 to August 2018). At each point of contact the research coordinator and PI collected data regarding any new symptoms or laboratory changes.
|
|
Skin and subcutaneous tissue disorders
Rash/skin lesion
|
4.0%
1/25 • Number of events 1 • Adverse event data were collected following signing of consent to completion of study week 28 (from May 2016 to August 2018). At each point of contact the research coordinator and PI collected data regarding any new symptoms or laboratory changes.
|
8.0%
2/25 • Number of events 2 • Adverse event data were collected following signing of consent to completion of study week 28 (from May 2016 to August 2018). At each point of contact the research coordinator and PI collected data regarding any new symptoms or laboratory changes.
|
Additional Information
Dr. Aaron Ritter
Cleveland Clinic Lou Ruvo Center for Brain Health
Phone: 702-483-6049
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place