NCT01922115

The Effect of Anticholinergics on Cognitive Function in the Elderly

The Effect of Anticholinergics on Cognitive Function in the Elderly: a Randomized Controlled Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: Female
• Age: 50 Years – 99 Years
• Healthy volunteers: Accepted

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.

Conditions

• Mental Competency
• Urinary Bladder, Overactive
• Cognitive Function

Interventions

Type	Name	Description
DRUG	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.
DRUG	Placebo

Timeline

• Start date: 2013-06-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2013-08-14
• Last updated: 2017-03-22
• Results posted: 2016-07-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study