The Effect of Anticholinergics on Cognitive Function in the Elderly

Cognitive Function Clinical Trial

— ACE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01922115
• Other study ID #: 13-1352
• Status: Completed
• Phase: Phase 4
• First received: August 9, 2013
• Last updated: October 19, 2015
• Start date: June 2013
• Est. completion date: June 2015

Study information

• Verified date: June 2015
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 99 Years

Eligibility

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)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cognitive Function
• Mental Competency
• Urinary Bladder, Overactive

Intervention

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.
• Placebo

Locations

Country	Name	City	State
United States	Unc Chapel Hill Urogynecology A2 Clinic	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	American Urogynecologic Society

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Effect of Anticholinergics on Cognitive Functioning the Elderly	Cognitive function will be examined through tried tests and questionnaires.	24 months	No