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NCT Number: NCT01922115

The Effect of Anticholinergics on Cognitive Function in the Elderly

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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Key information

Conditions

Mental Competency Cognitive Function Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

50 year–99 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Unc Chapel Hill Urogynecology A2 Clinic

Chapel Hill, North Carolina, 27517, United States

About this study

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

There are three aims:

  • To evaluate changes in cognitive function in elderly women taking trospium versus placebo, using validated cognitive assessment tests
  • To develop a useful battery of cognitive screening tests for monitoring the cognitive safety of OAB management
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Trospium Chloride

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.

Other names: Sanctura XR

Placebo

Drug

Primary outcomes

  1. 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.

  2. 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 outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • American Urogynecologic Society

Registry information

Official study title

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

Acronym: ACE

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Aug 14, 2013
Registry last updated
Mar 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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