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

Parkinson's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01723228
• Other study ID #: TVP-1012/PM106
• Status: Completed
• Phase: Phase 4
• Start date: November 2012
• Est. completion date: January 2015

Study information

• Verified date: November 2021
• Source: Teva Branded Pharmaceutical Products R&D, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• Rasagiline

• Placebo

Locations

Country	Name	City	State
United States	Teva Investigational Site 014	Albany	New York
United States	Teva Investigational Site 022	Asheville	North Carolina
United States	Teva Investigational Site 019	Atlanta	Georgia
United States	Teva Investigational Site 046	Baton Rouge	Louisiana
United States	Teva Investigational Site 036	Birmingham	Alabama
United States	Teva Investigational Site 015	Boca Raton	Florida
United States	Teva Investigational Site 024	Boston	Massachusetts
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 045	Commack	New York
United States	Teva Investigational Site 035	Danbury	Connecticut
United States	Teva Investigational Site 048	Denver	Colorado
United States	Teva Investigational Site 038	Englewood	Colorado
United States	Teva Investigational Site 004	Irvine	California
United States	Teva Investigational Site 021	Jacksonville	Florida
United States	Teva Investigational Site 025	Kansas City	Kansas
United States	Teva Investigational Site 013	Kingston	New York
United States	Teva Investigational Site 001	La Crosse	Wisconsin
United States	Teva Investigational Site 016	La Jolla	California
United States	Teva Investigational Site 031	Las Vegas	Nevada
United States	Teva Investigational Site 009	Lexington	Kentucky
United States	Teva Investigational Site 042	Long Beach	California
United States	Teva Investigational Site 034	Manchester	Connecticut
United States	Teva Investigational Site 012	Nashville	Tennessee
United States	Teva Investigational Site 030	New Brunswick	New Jersey
United States	Teva Investigational Site 037	New London	Connecticut
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 033	Ormond Beach	Florida
United States	Teva Investigational Site 028	Philadelphia	Pennsylvania
United States	Teva Investigational Site 020	Port Charlotte	Florida
United States	Teva Investigational Site 005	Raleigh	North Carolina
United States	Teva Investigational Site 017	Saint Petersburg	Florida
United States	Teva Investigational Site 011	Salt Lake City	Utah
United States	Teva Investigational Site 002	San Antonio	Texas
United States	Teva Investigational Site 041	San Bernardino	California
United States	Teva Investigational Site 047	Sun City	Arizona
United States	Teva Investigational Site 018	Toledo	Ohio
United States	Teva Investigational Site 026	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Teva Branded Pharmaceutical Products R&D, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	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).	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).	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.'	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.	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.	Baseline to week 24 (or early discontinuation)