The Effect of Anticholinergics on Cognitive Function in the Elderly

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2015-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Mental Competency Urinary Bladder, Overactive Cognitive Function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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TROSPIUM CHLORIDE

Those with overactive bladder will be administered either a placebo or Sanctura XR extended release (Trospium chloride) for treatment (60 mg).

Group Type ACTIVE_COMPARATOR

Trospium Chloride

Intervention Type DRUG

Subject will be administered either placebo or 60 mg dosage of Sanctura XR for treatment of overactive bladder. Subject will take Sanctura XR once every morning. Blood will be drawn for plasma extraction at each visit.

PLACEBO

Subjects may be administered a placebo rather than the Sanctura XR (Trospium Chloride).

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Trospium Chloride

Subject will be administered either placebo or 60 mg dosage of Sanctura XR for treatment of overactive bladder. Subject will take Sanctura XR once every morning. Blood will be drawn for plasma extraction at each visit.

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Sanctura XR

Eligibility Criteria

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Inclusion Criteria

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

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)

Minimum Eligible Age

50 Years

Maximum Eligible Age

99 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes