The Effect of Anticholinergics on Cognitive Function in the Elderly

Phase 4

Completed

• Conditions: Cognitive Function; Mental Competency; Urinary Bladder, Overactive
• Interventions: Drug: Trospium Chloride; Drug: Placebo

• Registration Number: NCT01922115
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary

Anticholinergic medication is used to treat overactive bladder (OAB). A known side effect of this medication is cognitive dysfunction. OAB is more prevalent in the elderly population - a group that also has a higher baseline risk of cognitive dysfunction. Our objective is to evaluate the effect of an anticholinergic medication on cognitive function in elderly women.

Detailed Description

Subjects will be randomized to: 1) trospium chloride or 2) placebo.

There are three aims:

1. To evaluate changes in cognitive function in elderly women taking trospium versus placebo, using validated cognitive assessment tests

2. To develop a useful battery of cognitive screening tests for monitoring the cognitive safety of OAB management

3. To understand how the timing of cognitive changes relates to the timing of improvement in OAB symptoms. The investigators will recruit 60 women aged ≥ 50 with the diagnosis of OAB. Cognitive assessments will be performed at baseline and Week 1 and 4 after drug initiation using paper-based validated questionnaires. OAB improvement will be assessed with validated questionnaires.

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-08-09
• Study First Submitted QC: 2013-08-13
• Study First Posted: 2013-08-14
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Results First Submitted: 2016-03-07
• Results First Submitted QC: 2016-06-01
• Results First Posted: 2016-07-12
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-17
• Last Update Posted: 2017-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 59

Inclusion Criteria

• Female 50 or older
• Diagnosis of OAB (ICS definition)
• English literacy
• Ability to swallow oral medication
• Cognitive ability to give consent

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Exclusion Criteria

• Dementia/Depression/Delirium
• Current anticholinergic use (requires 2 week washout period)
• Current cholinesterase
• Urinary or gastric retention
• Severe decreased gastrointestinal motility
• Uncontrolled narrow-angle glaucoma
• Myasthenia gravis
• Diagnosis fo renal impairment (creatinine clearance <30 mL/min)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TROSPIUM CHLORIDE	Trospium Chloride	Those with overactive bladder will be administered either a placebo or Sanctura XR extended release (Trospium chloride) for treatment (60 mg).
PLACEBO	Placebo	Subjects may be administered a placebo rather than the Sanctura XR (Trospium Chloride).

Primary Outcome Measures

Name	Time	Method
Hopkins Verbal Learning Test - Revised	Week 4	Assesses short term verbal learning and memory. See below for the subscale delayed recognition (0-24). Percentages of total responses correct are reported for delayed recognition, higher values indicate better outcomes.

Secondary Outcome Measures

Name	Time	Method
Mini-Mental State Examination	Week 4	The mini-mental state examination (MMSE) or Folstein test is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. It is commonly used in medicine and allied health to screen for dementia. The range is 0-30, with higher values indicating better outcomes.
Overactive Bladder Questionnaire	Week 4	The Overactive Bladder Questionnaire (OAB-q) was developed to assess symptom bother and the impact of overactive bladder (OAB) on health-related quality of life (HRQL). The instrument was developed and validated in both continent and incontinent OAB patients, including both men and women. Total range is 19-101 and higher values indicate worse outcomes.

Trial Locations

Locations (1)

Unc Chapel Hill Urogynecology A2 Clinic; 🇺🇸 Chapel Hill, North Carolina, United States