Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rasagiline 1.0 mg/day | Experimental | Rasagiline 1 mg oral tablets once daily for 24 weeks |
|
| Placebo | Placebo Comparator | Placebo oral tablets once daily for 24 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rasagiline | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to Week 24 (or early discontinuation) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline to Week 24 (or early discontinuation) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Teva Medical Expert | Teva Branded Pharmaceutical Products R&D, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Teva Investigational Site 036 | Birmingham | Alabama | United States | |||
| Teva Investigational Site 047 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21500280 | Background | Hanagasi HA, Gurvit H, Unsalan P, Horozoglu H, Tuncer N, Feyzioglu A, Gunal DI, Yener GG, Cakmur R, Sahin HA, Emre M. The effects of rasagiline on cognitive deficits in Parkinson's disease patients without dementia: a randomized, double-blind, placebo-controlled, multicenter study. Mov Disord. 2011 Aug 15;26(10):1851-8. doi: 10.1002/mds.23738. Epub 2011 Apr 15. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Rasagiline 1.0 mg/Day | Rasagiline 1 mg oral tablets once daily for 24 weeks |
| FG001 | Placebo | Placebo oral tablets once daily for 24 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug |
|
| 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). |
| Baseline to Week 24 (or early discontinuation) |
| 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.' | Week 24 (or early discontinuation) |
| 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. | Baseline to Week 24 (or early discontinuation) |
| 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. | Baseline to week 24 (or early discontinuation) |
| Sun City |
| Arizona |
| United States |
| Teva Investigational Site 004 | Irvine | California | United States |
| Teva Investigational Site 016 | La Jolla | California | United States |
| Teva Investigational Site 042 | Long Beach | California | United States |
| Teva Investigational Site 041 | San Bernardino | California | United States |
| Teva Investigational Site 048 | Denver | Colorado | United States |
| Teva Investigational Site 038 | Englewood | Colorado | United States |
| Teva Investigational Site 035 | Danbury | Connecticut | United States |
| Teva Investigational Site 034 | Manchester | Connecticut | United States |
| Teva Investigational Site 037 | New London | Connecticut | United States |
| Teva Investigational Site 026 | Washington D.C. | District of Columbia | United States |
| Teva Investigational Site 015 | Boca Raton | Florida | United States |
| Teva Investigational Site 021 | Jacksonville | Florida | United States |
| Teva Investigational Site 033 | Ormond Beach | Florida | United States |
| Teva Investigational Site 020 | Port Charlotte | Florida | United States |
| Teva Investigational Site 017 | St. Petersburg | Florida | United States |
| Teva Investigational Site 019 | Atlanta | Georgia | United States |
| Teva Investigational Site 003 | Chicago | Illinois | United States |
| Teva Investigational Site 006 | Chicago | Illinois | United States |
| Teva Investigational Site 008 | Chicago | Illinois | United States |
| Teva Investigational Site 025 | Kansas City | Kansas | United States |
| Teva Investigational Site 009 | Lexington | Kentucky | United States |
| Teva Investigational Site 046 | Baton Rouge | Louisiana | United States |
| Teva Investigational Site 024 | Boston | Massachusetts | United States |
| Teva Investigational Site 031 | Las Vegas | Nevada | United States |
| Teva Investigational Site 030 | New Brunswick | New Jersey | United States |
| Teva Investigational Site 014 | Albany | New York | United States |
| Teva Investigational Site 045 | Commack | New York | United States |
| Teva Investigational Site 013 | Kingston | New York | United States |
| Teva Investigational Site 010 | New York | New York | United States |
| Teva Investigational Site 040 | New York | New York | United States |
| Teva Investigational Site 022 | Asheville | North Carolina | United States |
| Teva Investigational Site 005 | Raleigh | North Carolina | United States |
| Teva Investigational Site 018 | Toledo | Ohio | United States |
| Teva Investigational Site 028 | Philadelphia | Pennsylvania | United States |
| Teva Investigational Site 012 | Nashville | Tennessee | United States |
| Teva Investigational Site 002 | San Antonio | Texas | United States |
| Teva Investigational Site 011 | Salt Lake City | Utah | United States |
| Teva Investigational Site 001 | La Crosse | Wisconsin | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Rasagiline 1.0 mg/Day | Rasagiline 1 mg oral tablets once daily for 24 weeks |
| BG001 | Placebo | Placebo oral tablets once daily for 24 weeks |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to Week 24 (or early discontinuation) |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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). | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to Week 24 (or early discontinuation) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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). | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to Week 24 (or early discontinuation) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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.' | 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. | Posted | Number | participants | Week 24 (or early discontinuation) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to Week 24 (or early discontinuation) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to week 24 (or early discontinuation) |
|
Baseline through Week 24
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rasagiline 1.0 mg/Day | Rasagiline 1 mg oral tablets once daily for 24 weeks | 1 | 86 | 24 | 86 | ||
| EG001 | Placebo | Placebo oral tablets once daily for 24 weeks | 1 | 84 | 14 | 84 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Research | Teva Branded Pharmaceutical Products, R&D Inc. | 215-591-3000 | ustevatrials@tevapharm.com |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C031967 | rasagiline |
| D008698 | Mesylates |
| ID | Term |
|---|---|
| D000476 | Alkanesulfonates |
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
Not provided
Not provided
| Male |
|
|
|
|
|
|
|
Placebo oral tablets once daily for 24 weeks |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|