Parkinson's Disease
Conditions
Keywords
Parkinson's Disease, Cognition, Rasagiline
Brief summary
This is a 24-week, multicenter, randomized, double-blind, placebo-controlled, add-on, parallel-group study to evaluate the effect of rasagiline on cognitive function in adults with mild cognitive impairment (MCI) in Parkinson's disease (PD-MCI).
Interventions
DRUGRasagiline
DRUGPlacebo
Sponsors
Teva Branded Pharmaceutical Products R&D, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
45 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Nondemented man or woman 45 through 80 years of age with idiopathic Parkinson's disease (PD) based on the United Kingdom (UK) Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria 2. Hoehn and Yahr stage ≥ 1 (symptoms on only 1 side of the body) with treatment and ≤ 3 (mild-to-moderate bilateral disease; some postural instability; physically independent) 3. Mild cognitive impairment in Parkinson's disease based on the Movement Disorder Society (MDS) Task Force Diagnostic Criteria and the Montreal Cognitive Assessment (MoCA) rating scale (range, 20-25, inclusive) 4. Medically stable outpatient, based on the investigator's judgment 5. The patient is on a stable dopaminergic medication regimen for ≥ 30 days before entering the study (Screening/Baseline Visit) 6. Other inclusion criteria apply; please contact the site for more information
Exclusion criteria
1. Clinically relevant history of vascular disease (eg, stroke) 2. History of melanoma 3. History of deep brain stimulation (DBS) 4. Impaired hepatic function, based on the investigator's judgment 5. Psychosis or is receiving antipsychotic treatment 6. Clinically significant or unstable medical or surgical condition that may preclude safe and complete study participation, based on the investigator's judgment 7. Other
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline to Week 24 in the Scales for Outcomes in Parkinson's Disease-Cognition (SCOPA-COG) Summary Score | Baseline to Week 24 (or early discontinuation) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Week 24 in the Montreal Cognitive Assessment (MoCA) Score | Baseline to Week 24 (or early discontinuation) | 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). |
| Change From Baseline to Week 24 in the Penn Daily Activities Questionnaire (PDAQ) Score | Baseline to Week 24 (or early discontinuation) | 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). |
| Alzheimer's Disease Cooperative Study's Clinical Global Impression of Change Modified for Mild Cognitive Impairment (ADCS MCI-CGIC) Score at Week 24 | Week 24 (or early discontinuation) | 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.' |
| Change From Baseline to Week 24 in the Unified Parkinson's Disease Rating Scale (UPDRS), Motor Subscale (Part 3), Version 3, Score | Baseline to Week 24 (or early discontinuation) | 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. |
| Change From Baseline to Week 24 in UPDRS, Activities of Daily Living (ADL) Subscale (Part 2), Version 3, Score | Baseline to week 24 (or early discontinuation) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Rasagiline 1.0 mg/Day Rasagiline 1 mg oral tablets once daily for 24 weeks | 86 |
| Placebo Placebo oral tablets once daily for 24 weeks | 84 |
| Total | 170 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 6 |
| Overall Study | Lost to Follow-up | 2 | 1 |
| Overall Study | Other | 2 | 1 |
| Overall Study | Protocol Violation | 0 | 2 |
| Overall Study | Withdrawal by Subject | 2 | 1 |
Baseline characteristics
| Characteristic | Rasagiline 1.0 mg/Day | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 66.9 years STANDARD_DEVIATION 7.44 | 68.1 years STANDARD_DEVIATION 8.22 | 67.5 years STANDARD_DEVIATION 7.84 |
| Sex: Female, Male Female | 21 Participants | 16 Participants | 37 Participants |
| Sex: Female, Male Male | 65 Participants | 68 Participants | 133 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 24 / 86 | 14 / 84 |
| serious Total, serious adverse events | 1 / 86 | 1 / 84 |
Outcome results
Primary
Mean Change From Baseline to Week 24 in the Scales for Outcomes in Parkinson's Disease-Cognition (SCOPA-COG) Summary Score
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.
Time frame: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Rasagiline 1.0 mg/Day | 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 |
| Placebo | Mean Change From Baseline to Week 24 in the Scales for Outcomes in Parkinson's Disease-Cognition (SCOPA-COG) Summary Score | 0.8 units on a scale | Standard Error 0.47 |
p-value: 0.220495% CI: [-0.48, 2.05]repeated measures model
Secondary
Alzheimer's Disease Cooperative Study's Clinical Global Impression of Change Modified for Mild Cognitive Impairment (ADCS MCI-CGIC) Score at Week 24
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.'
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rasagiline 1.0 mg/Day | 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 |
| Rasagiline 1.0 mg/Day | 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 |
| Rasagiline 1.0 mg/Day | 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 |
| Rasagiline 1.0 mg/Day | 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 |
| Rasagiline 1.0 mg/Day | 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 |
| Rasagiline 1.0 mg/Day | 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 |
| Rasagiline 1.0 mg/Day | 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 |
| Rasagiline 1.0 mg/Day | 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 |
| Rasagiline 1.0 mg/Day | 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 |
| Rasagiline 1.0 mg/Day | 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 |
| Rasagiline 1.0 mg/Day | 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 |
| Rasagiline 1.0 mg/Day | 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 |
| Rasagiline 1.0 mg/Day | 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 |
| Rasagiline 1.0 mg/Day | 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 |
| Rasagiline 1.0 mg/Day | 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 |
| Rasagiline 1.0 mg/Day | 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 |
| Rasagiline 1.0 mg/Day | 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 |
| Rasagiline 1.0 mg/Day | 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 |
| Rasagiline 1.0 mg/Day | 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 |
| Rasagiline 1.0 mg/Day | 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 |
| Rasagiline 1.0 mg/Day | 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 |
| Rasagiline 1.0 mg/Day | 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 |
| Rasagiline 1.0 mg/Day | 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 |
| Rasagiline 1.0 mg/Day | 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 |
| Rasagiline 1.0 mg/Day | 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 |
| Rasagiline 1.0 mg/Day | 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 |
| Rasagiline 1.0 mg/Day | 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 |
| Rasagiline 1.0 mg/Day | 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 |
| Placebo | 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 |
| Placebo | 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 | 4 participants |
| Placebo | 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 | 7 participants |
| Placebo | 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 | 23 participants |
| Placebo | 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 | 33 participants |
| Placebo | 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 | 12 participants |
| Placebo | 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 | 0 participants |
| Placebo | 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 |
| Placebo | 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 | 3 participants |
| Placebo | 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 | 4 participants |
| Placebo | 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 | 18 participants |
| Placebo | 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 | 44 participants |
| Placebo | 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 | 8 participants |
| Placebo | 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 | 2 participants |
| Placebo | 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 |
| Placebo | 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 | 3 participants |
| Placebo | 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 | 1 participants |
| Placebo | 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 |
| Placebo | 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 | 62 participants |
| Placebo | 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 | 2 participants |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 | 3 participants |
| Placebo | 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 | 4 participants |
| Placebo | 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 | 12 participants |
| Placebo | 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 | 55 participants |
| Placebo | 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 | 5 participants |
| Placebo | 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 | 0 participants |
Comparison: CGIC Functional Abilitiesp-value: 0.3331Cochran-Mantel-Haenszel
Comparison: CGICp-value: 0.114895% CI: [0.89, 2.93]Proportional Odds Model
Comparison: CGICp-value: 0.1052Cochran-Mantel-Haenszel
Comparison: CGIC Cognitionp-value: 0.885795% CI: [0.52, 1.75]Proportional Odds Model
Comparison: CGIC Cognitionp-value: 0.9945Cochran-Mantel-Haenszel
Comparison: CGIC Behaviorp-value: 0.690995% CI: [0.56, 2.43]Proportional Odds Model
Comparison: CGIC Behaviorp-value: 0.6639Cochran-Mantel-Haenszel
Comparison: CGIC Functional Abilitiesp-value: 0.320495% CI: [0.72, 2.68]Proportional Odds Model
Secondary
Change From Baseline to Week 24 in the Montreal Cognitive Assessment (MoCA) Score
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).
Time frame: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Rasagiline 1.0 mg/Day | Change From Baseline to Week 24 in the Montreal Cognitive Assessment (MoCA) Score | 0.9 units on a scale | Standard Error 0.32 |
| Placebo | Change From Baseline to Week 24 in the Montreal Cognitive Assessment (MoCA) Score | 1.0 units on a scale | Standard Error 0.34 |
p-value: 0.842895% CI: [-0.99, 0.81]Repeated Measures Model
Secondary
Change From Baseline to Week 24 in the Penn Daily Activities Questionnaire (PDAQ) Score
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).
Time frame: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Rasagiline 1.0 mg/Day | Change From Baseline to Week 24 in the Penn Daily Activities Questionnaire (PDAQ) Score | -0.9 units on a scale | Standard Error 0.72 |
| Placebo | Change From Baseline to Week 24 in the Penn Daily Activities Questionnaire (PDAQ) Score | -0.1 units on a scale | Standard Error 0.75 |
p-value: 0.479695% CI: [-2.74, 1.3]ANCOVA
Secondary
Change From Baseline to Week 24 in the Unified Parkinson's Disease Rating Scale (UPDRS), Motor Subscale (Part 3), Version 3, Score
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.
Time frame: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Rasagiline 1.0 mg/Day | 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 0.7 |
| Placebo | Change From Baseline to Week 24 in the Unified Parkinson's Disease Rating Scale (UPDRS), Motor Subscale (Part 3), Version 3, Score | -1.2 units on a scale | Standard Error 0.73 |
p-value: 0.015195% CI: [-4.47, -0.49]Repeated Measures Model
Secondary
Change From Baseline to Week 24 in UPDRS, Activities of Daily Living (ADL) Subscale (Part 2), Version 3, Score
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.
Time frame: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Rasagiline 1.0 mg/Day | 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 |
| Placebo | Change From Baseline to Week 24 in UPDRS, Activities of Daily Living (ADL) Subscale (Part 2), Version 3, Score | 1.4 units on a scale | Standard Error 0.45 |
p-value: 0.000395% CI: [-3.53, -1.08]Repeated Measures Model