Trial Outcomes & Findings for Parallel-Group Study to Assess the Effect of Rasagiline on Cognition in Patients With Parkinson's Disease (NCT NCT01723228)
NCT ID: NCT01723228
Last Updated: 2021-11-09
Results Overview
The SCOPA-COG consists of evaluations in 4 domains: memory, attention, executive functioning, and visuospatial functioning.Scores range from 0 to 43, with higher scores reflecting better performance.
COMPLETED
PHASE4
170 participants
Baseline to Week 24 (or early discontinuation)
2021-11-09
Participant Flow
Participant milestones
| Measure |
Rasagiline 1.0 mg/Day
Rasagiline 1 mg oral tablets once daily for 24 weeks
|
Placebo
Placebo oral tablets once daily for 24 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
86
|
84
|
|
Overall Study
COMPLETED
|
78
|
73
|
|
Overall Study
NOT COMPLETED
|
8
|
11
|
Reasons for withdrawal
| Measure |
Rasagiline 1.0 mg/Day
Rasagiline 1 mg oral tablets once daily for 24 weeks
|
Placebo
Placebo oral tablets once daily for 24 weeks
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
6
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
|
Overall Study
Protocol Violation
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Other
|
2
|
1
|
Baseline Characteristics
Parallel-Group Study to Assess the Effect of Rasagiline on Cognition in Patients With Parkinson's Disease
Baseline characteristics by cohort
| Measure |
Rasagiline 1.0 mg/Day
n=86 Participants
Rasagiline 1 mg oral tablets once daily for 24 weeks
|
Placebo
n=84 Participants
Placebo oral tablets once daily for 24 weeks
|
Total
n=170 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.9 years
STANDARD_DEVIATION 7.44 • n=5 Participants
|
68.1 years
STANDARD_DEVIATION 8.22 • n=7 Participants
|
67.5 years
STANDARD_DEVIATION 7.84 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
65 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
133 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 24 (or early discontinuation)Population: Modified intent-to-treat population: all participants who were randomized, received at least 1 dose of study drug and had at least 1 postbaseline SCOPA-COG assessment.
The SCOPA-COG consists of evaluations in 4 domains: memory, attention, executive functioning, and visuospatial functioning.Scores range from 0 to 43, with higher scores reflecting better performance.
Outcome measures
| Measure |
Rasagiline 1.0 mg/Day
n=82 Participants
Rasagiline 1 mg oral tablets once daily for 24 weeks
|
Placebo
n=80 Participants
Placebo oral tablets once daily for 24 weeks
|
|---|---|---|
|
Mean Change From Baseline to Week 24 in the Scales for Outcomes in Parkinson's Disease-Cognition (SCOPA-COG) Summary Score
|
1.6 units on a scale
Standard Error 0.45
|
0.8 units on a scale
Standard Error 0.47
|
SECONDARY outcome
Timeframe: Baseline to Week 24 (or early discontinuation)Population: Modified intent-to-treat population: all participants who were randomized, received at least 1 dose of study drug and had at least 1 postbaseline MoCA assessment.
The MoCA assesses 8 cognitive areas: visuospatial/executive, naming, memory, attention, language, abstraction, delayed recall, and orientation. Scores range from 0 (worst) to 30 (best).
Outcome measures
| Measure |
Rasagiline 1.0 mg/Day
n=82 Participants
Rasagiline 1 mg oral tablets once daily for 24 weeks
|
Placebo
n=80 Participants
Placebo oral tablets once daily for 24 weeks
|
|---|---|---|
|
Change From Baseline to Week 24 in the Montreal Cognitive Assessment (MoCA) Score
|
0.9 units on a scale
Standard Error 0.32
|
1.0 units on a scale
Standard Error 0.34
|
SECONDARY outcome
Timeframe: Baseline to Week 24 (or early discontinuation)Population: Modified intent-to-treat population: all participants who were randomized, received at least 1 dose of study drug and had at least 1 postbaseline PDAQ assessment.
The PDAQ is a 15-item questionnaire that assesses the patient's difficulty with activities of daily living. The total score has a range of 0 (no impairment) to 60 (severe impairment).
Outcome measures
| Measure |
Rasagiline 1.0 mg/Day
n=82 Participants
Rasagiline 1 mg oral tablets once daily for 24 weeks
|
Placebo
n=80 Participants
Placebo oral tablets once daily for 24 weeks
|
|---|---|---|
|
Change From Baseline to Week 24 in the Penn Daily Activities Questionnaire (PDAQ) Score
|
-0.9 units on a scale
Standard Error 0.72
|
-0.1 units on a scale
Standard Error 0.75
|
SECONDARY outcome
Timeframe: Week 24 (or early discontinuation)Population: Modified intent-to-treat population: all participants who were randomized, received at least 1 dose of study drug and had at least 1 postbaseline ADCS MCI-CGIC assessment. n=number of participants with the given assessment.
The ADCS MCI-CGIC score is generated in the context of a semi-structured interview and is an indication of the change in the participant's global status, cognition, behavior, and functional abilities (FA) on a 7-point scale, with the best score being 'marked improvement' and the worst being 'marked worsening.'
Outcome measures
| Measure |
Rasagiline 1.0 mg/Day
n=80 Participants
Rasagiline 1 mg oral tablets once daily for 24 weeks
|
Placebo
n=82 Participants
Placebo oral tablets once daily for 24 weeks
|
|---|---|---|
|
Alzheimer's Disease Cooperative Study's Clinical Global Impression of Change Modified for Mild Cognitive Impairment (ADCS MCI-CGIC) Score at Week 24
CGIC: Marked improvement; n=78, 79
|
1 participants
|
4 participants
|
|
Alzheimer's Disease Cooperative Study's Clinical Global Impression of Change Modified for Mild Cognitive Impairment (ADCS MCI-CGIC) Score at Week 24
CGIC: Moderate improvement; n=78, 79
|
9 participants
|
7 participants
|
|
Alzheimer's Disease Cooperative Study's Clinical Global Impression of Change Modified for Mild Cognitive Impairment (ADCS MCI-CGIC) Score at Week 24
CGIC: Minimal improvement; n=78, 79
|
11 participants
|
23 participants
|
|
Alzheimer's Disease Cooperative Study's Clinical Global Impression of Change Modified for Mild Cognitive Impairment (ADCS MCI-CGIC) Score at Week 24
CGIC: No change; n=78, 79
|
42 participants
|
33 participants
|
|
Alzheimer's Disease Cooperative Study's Clinical Global Impression of Change Modified for Mild Cognitive Impairment (ADCS MCI-CGIC) Score at Week 24
CGIC: Minimal worsening; n=78, 79
|
14 participants
|
12 participants
|
|
Alzheimer's Disease Cooperative Study's Clinical Global Impression of Change Modified for Mild Cognitive Impairment (ADCS MCI-CGIC) Score at Week 24
CGIC: Moderate worsening; n=78, 79
|
1 participants
|
0 participants
|
|
Alzheimer's Disease Cooperative Study's Clinical Global Impression of Change Modified for Mild Cognitive Impairment (ADCS MCI-CGIC) Score at Week 24
CGIC: Marked worsening; n=78, 79
|
0 participants
|
0 participants
|
|
Alzheimer's Disease Cooperative Study's Clinical Global Impression of Change Modified for Mild Cognitive Impairment (ADCS MCI-CGIC) Score at Week 24
CGIC Cognition: Marked improvement; n=77, 79
|
0 participants
|
3 participants
|
|
Alzheimer's Disease Cooperative Study's Clinical Global Impression of Change Modified for Mild Cognitive Impairment (ADCS MCI-CGIC) Score at Week 24
CGIC Cognition: Moderate improvement; n=77, 79
|
9 participants
|
4 participants
|
|
Alzheimer's Disease Cooperative Study's Clinical Global Impression of Change Modified for Mild Cognitive Impairment (ADCS MCI-CGIC) Score at Week 24
CGIC Cognition: Minimal improvement; n=77, 79
|
15 participants
|
18 participants
|
|
Alzheimer's Disease Cooperative Study's Clinical Global Impression of Change Modified for Mild Cognitive Impairment (ADCS MCI-CGIC) Score at Week 24
CGIC Cognition: No change; n=77, 79
|
41 participants
|
44 participants
|
|
Alzheimer's Disease Cooperative Study's Clinical Global Impression of Change Modified for Mild Cognitive Impairment (ADCS MCI-CGIC) Score at Week 24
CGIC Cognition: Minimal worsening; n=77, 79
|
9 participants
|
8 participants
|
|
Alzheimer's Disease Cooperative Study's Clinical Global Impression of Change Modified for Mild Cognitive Impairment (ADCS MCI-CGIC) Score at Week 24
CGIC Cognition: Moderate worsening; n=77, 79
|
3 participants
|
2 participants
|
|
Alzheimer's Disease Cooperative Study's Clinical Global Impression of Change Modified for Mild Cognitive Impairment (ADCS MCI-CGIC) Score at Week 24
CGIC Cognition: Marked worsening; n=77, 79
|
0 participants
|
0 participants
|
|
Alzheimer's Disease Cooperative Study's Clinical Global Impression of Change Modified for Mild Cognitive Impairment (ADCS MCI-CGIC) Score at Week 24
CGIC Behavior: Marked improvement; n=76, 79
|
0 participants
|
3 participants
|
|
Alzheimer's Disease Cooperative Study's Clinical Global Impression of Change Modified for Mild Cognitive Impairment (ADCS MCI-CGIC) Score at Week 24
CGIC Behavior: Moderate improvement; n=76, 79
|
4 participants
|
1 participants
|
|
Alzheimer's Disease Cooperative Study's Clinical Global Impression of Change Modified for Mild Cognitive Impairment (ADCS MCI-CGIC) Score at Week 24
CGIC Behavior: Minimal improvement; n=76, 79
|
11 participants
|
11 participants
|
|
Alzheimer's Disease Cooperative Study's Clinical Global Impression of Change Modified for Mild Cognitive Impairment (ADCS MCI-CGIC) Score at Week 24
CGIC Behavior: No change; n=76, 79
|
54 participants
|
62 participants
|
|
Alzheimer's Disease Cooperative Study's Clinical Global Impression of Change Modified for Mild Cognitive Impairment (ADCS MCI-CGIC) Score at Week 24
CGIC Behavior: Minimal worsening; n=76, 79
|
7 participants
|
2 participants
|
|
Alzheimer's Disease Cooperative Study's Clinical Global Impression of Change Modified for Mild Cognitive Impairment (ADCS MCI-CGIC) Score at Week 24
CGIC Behavior: Moderate worsening; n=76, 79
|
0 participants
|
0 participants
|
|
Alzheimer's Disease Cooperative Study's Clinical Global Impression of Change Modified for Mild Cognitive Impairment (ADCS MCI-CGIC) Score at Week 24
CGIC Behavior: Marked worsening; n=76, 79
|
0 participants
|
0 participants
|
|
Alzheimer's Disease Cooperative Study's Clinical Global Impression of Change Modified for Mild Cognitive Impairment (ADCS MCI-CGIC) Score at Week 24
CGIC FA: Marked improvement; n=76, 79
|
0 participants
|
3 participants
|
|
Alzheimer's Disease Cooperative Study's Clinical Global Impression of Change Modified for Mild Cognitive Impairment (ADCS MCI-CGIC) Score at Week 24
CGIC FA: Moderate improvement; n=76, 79
|
5 participants
|
4 participants
|
|
Alzheimer's Disease Cooperative Study's Clinical Global Impression of Change Modified for Mild Cognitive Impairment (ADCS MCI-CGIC) Score at Week 24
CGIC FA: Minimal improvement; n=76, 79
|
13 participants
|
12 participants
|
|
Alzheimer's Disease Cooperative Study's Clinical Global Impression of Change Modified for Mild Cognitive Impairment (ADCS MCI-CGIC) Score at Week 24
CGIC FA: No change; n=76, 79
|
44 participants
|
55 participants
|
|
Alzheimer's Disease Cooperative Study's Clinical Global Impression of Change Modified for Mild Cognitive Impairment (ADCS MCI-CGIC) Score at Week 24
CGIC FA: Minimal worsening; n=76, 79
|
12 participants
|
5 participants
|
|
Alzheimer's Disease Cooperative Study's Clinical Global Impression of Change Modified for Mild Cognitive Impairment (ADCS MCI-CGIC) Score at Week 24
CGIC FA: Moderate worsening; n=76, 79
|
2 participants
|
0 participants
|
|
Alzheimer's Disease Cooperative Study's Clinical Global Impression of Change Modified for Mild Cognitive Impairment (ADCS MCI-CGIC) Score at Week 24
CGIC FA: Marked worsening; n=76, 79
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline to Week 24 (or early discontinuation)Population: Modified intent-to-treat population: all participants who were randomized, received at least 1 dose of study drug and had at least 1 postbaseline UPDRS Motor Subscale (Part 3) assessment.
UPDRS Part 3 (motor examination subscale) comprises 14 items assessing the motor disabilities of the patient at the time of the visit. The participant's speech, facial expressions, ability to arise from a chair (with arms folded), posture, gait, postural stability (retropulsion test), and body bradykinesia and hypokinesia are assessed. In addition, the following evaluations require assessment of the face, neck or extremities: tremor at rest, action or postural tremor of hands, rigidity, finger taps, hand movements (open and close), rapid alternating movements of hands (pronation and supination), and leg agility (tap heel on ground). This evaluation is performed while the participant is in the 'on' phase. Each item is assessed on a scale from 0 (normal, absent, or none) to 4 (severe impairment), which are summed to get the sub-scale score. The total scale is 0-57 with a higher score indicating more severe symptoms; a decrease in the scores indicates improvement.
Outcome measures
| Measure |
Rasagiline 1.0 mg/Day
n=81 Participants
Rasagiline 1 mg oral tablets once daily for 24 weeks
|
Placebo
n=79 Participants
Placebo oral tablets once daily for 24 weeks
|
|---|---|---|
|
Change From Baseline to Week 24 in the Unified Parkinson's Disease Rating Scale (UPDRS), Motor Subscale (Part 3), Version 3, Score
|
-3.7 units on a scale
Standard Error 0.70
|
-1.2 units on a scale
Standard Error 0.73
|
SECONDARY outcome
Timeframe: Baseline to week 24 (or early discontinuation)Population: Modified intent-to-treat population: all participants who were randomized, received at least 1 dose of study drug and had at least 1 postbaseline UPDRS ADL Subscale (Part 2) assessment.
UPDRS Part 2 (ADL subscale) comprises 13 items evaluating the impact of PD on patients' ADL (in both the on and off states) in the week prior to the visit. The following 13 ADL are assessed: speech, salivation, swallowing, handwriting, cutting food and handling utensils, dressing, hygiene, turning in bed and adjusting bed clothes, falling (unrelated to freezing), freezing when walking, walking, tremor, and sensory complaints related to Parkinsonism. Each item is assessed on a scale from 0 (normal, absent, or none) to 4 (severe impairment), which are summed to get the sub-scale score. The total scale is 0-52 with a higher score indicating more severe symptoms; a decrease in the scores indicates improvement.
Outcome measures
| Measure |
Rasagiline 1.0 mg/Day
n=82 Participants
Rasagiline 1 mg oral tablets once daily for 24 weeks
|
Placebo
n=80 Participants
Placebo oral tablets once daily for 24 weeks
|
|---|---|---|
|
Change From Baseline to Week 24 in UPDRS, Activities of Daily Living (ADL) Subscale (Part 2), Version 3, Score
|
-0.9 units on a scale
Standard Error 0.43
|
1.4 units on a scale
Standard Error 0.45
|
Adverse Events
Rasagiline 1.0 mg/Day
Placebo
Serious adverse events
| Measure |
Rasagiline 1.0 mg/Day
n=86 participants at risk
Rasagiline 1 mg oral tablets once daily for 24 weeks
|
Placebo
n=84 participants at risk
Placebo oral tablets once daily for 24 weeks
|
|---|---|---|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/86 • Baseline through Week 24
|
1.2%
1/84 • Number of events 1 • Baseline through Week 24
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/86 • Baseline through Week 24
|
1.2%
1/84 • Number of events 1 • Baseline through Week 24
|
|
Nervous system disorders
Transient ischaemic attack
|
1.2%
1/86 • Number of events 1 • Baseline through Week 24
|
0.00%
0/84 • Baseline through Week 24
|
Other adverse events
| Measure |
Rasagiline 1.0 mg/Day
n=86 participants at risk
Rasagiline 1 mg oral tablets once daily for 24 weeks
|
Placebo
n=84 participants at risk
Placebo oral tablets once daily for 24 weeks
|
|---|---|---|
|
Injury, poisoning and procedural complications
Fall
|
8.1%
7/86 • Number of events 7 • Baseline through Week 24
|
10.7%
9/84 • Number of events 9 • Baseline through Week 24
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.8%
5/86 • Number of events 5 • Baseline through Week 24
|
1.2%
1/84 • Number of events 1 • Baseline through Week 24
|
|
Nervous system disorders
Dizziness
|
8.1%
7/86 • Number of events 7 • Baseline through Week 24
|
4.8%
4/84 • Number of events 4 • Baseline through Week 24
|
|
Nervous system disorders
Headache
|
5.8%
5/86 • Number of events 5 • Baseline through Week 24
|
2.4%
2/84 • Number of events 3 • Baseline through Week 24
|
|
Vascular disorders
Orthostatic hypotension
|
5.8%
5/86 • Number of events 5 • Baseline through Week 24
|
1.2%
1/84 • Number of events 1 • Baseline through Week 24
|
Additional Information
Director, Clinical Research
Teva Branded Pharmaceutical Products, R&D Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.
- Publication restrictions are in place
Restriction type: OTHER