The Effect of Anticholinergics on Cognitive Function in the Elderly

Overview

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.

Full Title of Study: “The Effect of Anticholinergics on Cognitive Function in the Elderly: a Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Basic Science
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: June 2015

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.

Interventions

  • 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

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • Hopkins Verbal Learning Test – Revised
    • Time Frame: Week 4
    • Assesses short term verbal learning and memory. Subscales include immediate recall (0-36) and delayed recall (0-12). Higher values indicate better outcomes.
  • Hopkins Verbal Learning Test – Revised
    • Time Frame: 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 Measures

  • Mini-Mental State Examination
    • Time Frame: 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
    • Time Frame: 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.

Participating in This Clinical Trial

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)

Gender Eligibility: Female

Minimum Age: 50 Years

Maximum Age: 99 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of North Carolina, Chapel Hill
  • Collaborator
    • American Urogynecologic Society
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Elizabeth Geller, MD, Principal Investigator, UNC CHAPEL HILL

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