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

This study is ongoing, but not recruiting participants.
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: August 8, 2014
Last verified: August 2014
  Purpose

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).


Condition Intervention Phase
Parkinson's Disease
Drug: Rasagiline
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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).



Estimated Enrollment: 170
Study Start Date: October 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rasagiline tablets (1 mg)

The rasagiline doses and matching placebo will look alike. The tablets are white to off-white, flat, beveled round tablets, debossed on 1 side with "GIL" and "1"; they are plain on the other side.

Patients will be instructed to take orally 1 mg of rasagiline or placebo once daily for 24 weeks. If a dose is missed, the next dose should be taken at the usual time on the following day. The patient should not double-up the dose of study drug.

Drug: Rasagiline
Other Names:
  • Azilect® (rasagiline [N-propargyl-1-(R)-aminoindan] mesylate)
  • TVP-1012
Placebo Comparator: Placebo (1 mg)

The rasagiline doses and matching placebo will look alike. The tablets are white to off-white, flat, beveled round tablets, debossed on 1 side with "GIL" and "1"; they are plain on the other side.

Patients will be instructed to take orally 1 mg of rasagiline or placebo once daily for 24 weeks. If a dose is missed, the next dose should be taken at the usual time on the following day. The patient should not double-up the dose of study drug.

Drug: Placebo

  Eligibility

Ages Eligible for Study:   45 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Nondemented man or woman 45 through 80 years of age with idiopathic PD based on the 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 (PD-MCI) based on the Movement Disorder Society (MDS) Task Force Diagnostic Criteria and the 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. .
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01723228

  Show 40 Study Locations
Sponsors and Collaborators
Teva Branded Pharmaceutical Products, R&D Inc.
  More Information

No publications provided

Responsible Party: Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )
ClinicalTrials.gov Identifier: NCT01723228     History of Changes
Other Study ID Numbers: TVP-1012/PM106
Study First Received: November 5, 2012
Last Updated: August 8, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Teva Pharmaceutical Industries:
Parkinson's Disease
Cognition
Rasagiline

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Rasagiline
Monoamine Oxidase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 16, 2014