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Parallel-Group Study to Assess the Effect of Rasagiline on Cognition in Patients With Parkinson's Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )
ClinicalTrials.gov Identifier:
NCT01723228
First received: November 5, 2012
Last updated: February 29, 2016
Last verified: February 2016

November 5, 2012
February 29, 2016
November 2012
January 2015   (final data collection date for primary outcome measure)
Mean Change From Baseline to Week 24 in the Scales for Outcomes in Parkinson's Disease-Cognition (SCOPA-COG) Summary Score [ Time Frame: Baseline to Week 24 (or early discontinuation) ] [ Designated as safety issue: No ]
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.
Mean Change From Baseline to Week 24 in the Scales for Outcomes in Parkinson's Disease-Cognition (SCOPA-COG) Summary Score [ Time Frame: Baseline to Week 24 (or early discontinuation) ] [ Designated as safety issue: No ]

The SCOPA-COG is scored from 0 to 43 (higher scores reflect better performance). The memory domain consists of 4 items (replicating the order in which cubes were pointed out, digit span backward, immediate and delayed word recall); the attention domain consists of 2 items (counting down by 3 and months backward); the executive functioning domain consists of 3 items (successive repetitions of fist-edge-palm movements, set shifting with dices, and fluency with animals); and the visuospatial functioning domain consists of a single item (mental reconstruction of figures).

All study raters will receive training on how to reliably complete the SCOPA-COG. The same site rater (PI or designee) must complete this scale at all visits.

Complete list of historical versions of study NCT01723228 on ClinicalTrials.gov Archive Site
  • Change From Baseline to Week 24 in the Montreal Cognitive Assessment (MoCA) Score [ Time Frame: Baseline to Week 24 (or early discontinuation) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to Week 24 (or early discontinuation) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 24 (or early discontinuation) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to Week 24 (or early discontinuation) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to week 24 (or early discontinuation) ] [ Designated as safety issue: No ]
    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.
  • Change from baseline to Week 24 in the Unified Parkinson's Disease Rating Scale (UPDRS), motor subscale (Part 3), Version 3, score [ Time Frame: Baseline to week 24 (or early discontinuation) ] [ Designated as safety issue: No ]

    UPDRS Part 3 (motor examination subscale) comprises 14 items assessing the motor disabilities of the patient at the time of the visit. The patient'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 patient is in the on phase.

    Each item is assessed on a scale from 0 (normal, absent, or none) to 4 (severe impairment).

  • Change From Baseline to Week 24 in the Montreal Cognitive Assessment (MoCA) Score [ Time Frame: Baseline to Week 24 (or early discontinuation) ] [ Designated as safety issue: No ]
    The MoCA assesses 8 cognitive areas: visuospatial/executive, naming, memory, attention, language, abstraction, delayed recall, and orientation. Each area is rated and a total score is arrived at; the total score is neither good or bad and is compared to the baseline score to assess an improvement or a decline.
  • Alzheimer's Disease Cooperative Study's Clinical Global Impression of Change Modified for Mild Cognitive Impairment (ADCS MCI-CGIC) Score at Week 24 [ Time Frame: Week 24 (or early discontinuation) ] [ Designated as safety issue: No ]
    The ADCS MCI-CGIC score is generated in the context of a semistructured interview and is an indication of the change in the patient's global status; the rater will rate Cognition, Behavior, and Functional Abilities all on a 7 point scale with the best score being Marked Improvement and the worst being Marked Worsening.
  • Change from baseline to Week 24 (or early discontinuation) in Unified Parkinson's Disease Rating Scale (UPDRS), activities of daily living (ADL) subscale (Part 2), Version 3, score [ Time Frame: Baseline to Week 24 (or early discontinuation) ] [ Designated as safety issue: No ]

    The UPDRS (Version 3) will be completed at the baseline, Week 4, Week 12, and Week 24 (or early discontinuation) Visits. 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 rated on a scale from 0 (normal) to 4 (severe impairment).

Not Provided
Not Provided
 
Parallel-Group Study to Assess the Effect of Rasagiline on Cognition in Patients With Parkinson's Disease
A 24-Week, Multicenter, Randomized, Double-blind, Placebo-Controlled, Add-on, Parallel-Group Study to Assess the Effect of Rasagiline on Cognition in Patients With Parkinson's Disease
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
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Parkinson's Disease
  • Drug: Rasagiline
    Other Names:
    • Azilect® (rasagiline [N-propargyl-1-(R)-aminoindan] mesylate)
    • TVP-1012
  • Drug: Placebo
  • Experimental: Rasagiline 1.0 mg/day
    Rasagiline 1 mg oral tablets once daily for 24 weeks
    Intervention: Drug: Rasagiline
  • Placebo Comparator: Placebo
    Placebo oral tablets once daily for 24 weeks
    Intervention: Drug: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
170
January 2015
January 2015   (final data collection date for primary outcome measure)

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 exclusion criteria apply; please contact the site for more information
Both
45 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01723228
TVP-1012/PM106
No
Not Provided
Not Provided
Teva Branded Pharmaceutical Products, R&D Inc.
Teva Branded Pharmaceutical Products, R&D Inc.
Not Provided
Study Director: Teva Medical Expert TEVA
Teva Pharmaceutical Industries
February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP