Mirabegron in Parkinson Disease and Impaired Cognition

Phase 4

Completed

• Conditions: Impaired Cognition; Parkinson Disease; Overactive Bladder
• Interventions: Drug: Placebo; Drug: mirabegron

• Registration Number: NCT02536976
• Lead Sponsor: HealthPartners Institute

Brief Summary

There is a high prevalence of OAB symptoms among patients with Parkinson's disease and a lack of pharmacotherapies with an acceptable side effect profile. Specifically, available anticholinergic medications have a high risk of cognitive side-effects, which preclude their use in PD patients with CI. PD can also cause a number of non-motor symptoms that are likely to be adversely affected by the currently available anticholinergic agents. Mirabegron is the first pharmacologic treatment which may not exacerbate CI, constipation, orthostatic hypotension (OH), somnolence, and dry mouth in PD.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-08-28
• Study First Submitted QC: 2015-08-31
• Study First Posted: 2015-09-01
• Study Start: 2015-12
• Status Verified: 2017-11
• Primary Completion: 2018-08-01
• Study Completion: 2018-08-01
• Results First Submitted: 2018-11-28
• Results First Submitted QC: 2019-04-17
• Last Update Submitted: 2019-04-17
• Results First Posted: 2019-05-08
• Last Update Posted: 2019-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Matching placebo
Active treatment	mirabegron	mirabegron

Primary Outcome Measures

Name	Time	Method
Change in Montreal Cognitive Assessment Total Score	From Week 2 to Week 14	Change in Montreal Cognitive Assessment Total Score between week 2 and week 14. The Montreal Cognitive Assessment is a screening tool for global cognitive function with a total score ranging from 0 to 30 units on a scale, with higher score indicating better cognitive global function. Normal range is 26 thru 30.

Secondary Outcome Measures

Name	Time	Method
Change in Overactive Bladder Questionnaire Subscale Scores	From Week 2 to Week 14	The Overactive Bladder Questionnaire (OABQ) is a 33-item, self-administered instrument that contains a symptom bother scale (8 items) and a health-related quality of life (HRQL) scale (25 items), pertaining to OAB symptoms impact on HRQL. Symptom bother score ranges from 0-100 with higher scores indicating greater severity of symptoms. The HRQL score ranges from 0-100 with higher scores indicating better quality of life.
Change in Unified Parkinson's Disease Rating Scale	From Week 2 to Week 14	The UPDRS assesses motor and functional abilities of the subjects as it pertains to Parkinson's disease. The total UPDRS score (range 0-199; defined for this study as the sum of Parts I, II, III, and IV (I-Mentation, behavior, and mood section (4 items; range 0-16); II-Activities of Daily Living (ADL; 13 items; range 0-52); III-motor section (27 items; range 0-108) and IV-complications section; 11 items; range 0-23) will be completed by history and examination. Higher scores indicate greater severity of Parkinson's disease symptoms.

Trial Locations

Locations (1)

Struthers Parkinson's Center; 🇺🇸 Golden Valley, Minnesota, United States