The Effect of Anticholinergics on Cognitive Function in the Elderly (ACE)

February 17, 2017 updated by: University of North Carolina, Chapel Hill

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27517
        • Unc Chapel Hill Urogynecology A2 Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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).
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.
Other Names:
  • Sanctura XR
PLACEBO_COMPARATOR: PLACEBO
Subjects may be administered a placebo rather than the Sanctura XR (Trospium Chloride).
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Week 4
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.
Week 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Week 4
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.
Week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Collaborators

American Urogynecologic Society

Investigators

  • Principal Investigator: Elizabeth Geller, MD, UNC Chapel Hill

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (ACTUAL)

June 1, 2015

Study Completion (ACTUAL)

June 1, 2015

Study Registration Dates

First Submitted

August 9, 2013

First Submitted That Met QC Criteria

August 13, 2013

First Posted (ESTIMATE)

August 14, 2013

Study Record Updates

Last Update Posted (ACTUAL)

March 22, 2017

Last Update Submitted That Met QC Criteria

February 17, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-1352

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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