A Study of Fesoterodine and Oxybutynin on Cognitive Function in Mild Cognitive Impairment

February 18, 2020 updated by: Adrian Wagg, University of Alberta

A Double Blind, Randomized Four Way Cross Over Study to Compare the Effect of Fesoterodine 4mg and 8mg Once Daily and Oxybutynin 5mg Twice Daily After Steady State Dosing Versus Placebo on Cognitive Function in Subjects With Overactive Bladder, Over the Age of 75 Years With Mild Cognitive Impairment

The purpose of this study is to assess the effects of fesoterodine at 4mg and 8mg doses versus a placebo and oxybutynin 5mg bid versus placebo on cognitive abilities in older people with overactive bladder and mild cognitive impairment.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a randomized placebo controlled, blinded four way cross over trial of the effect of medications used to treat overactive bladder on the cognition of older men and women with mild cognitive impairment. Each treatment phase is a week, with a weeks washout period before starting the next treatment. Cognitive testing is by way of a validated computer assisted battery of tests

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
47

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

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

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2P4
        • Division of Geriatric Medicine, Clinical Sciences Building, University of Alberta Hosp

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

75 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. The subject is either male or female and ≥ 75 years of age.
  2. The subject has OAB as determined by ICS criteria
  3. The subject has mild cognitive impairment as determined by NIA criteria
  4. The subject is competent to give informed consent and perform the tasks associated with the study
  5. The subject has a body mass index (BMI) between 18.0 to 30.0 kg/m2 inclusive.
  6. Written informed consent has been obtained.
  7. The subject is available to complete the study.
  8. At training visits (visit 2): the subject has performed at or above the minimum level on at least one occasion for each individual task measure in cognitive function test training.

Exclusion Criteria:

  1. The subject does not have OAB.
  2. The subject has either dementia or moderate to severe cognitive impairment at screening.
  3. The subject has probable clinical depression as determined by Geriatric Depression Scale (GDS) short form >5 at screening.
  4. Subjects taking any cognitive enhancers (cholinesterase inhibitors or memantine).
  5. The subject has a history of allergy to the study drug(s), to any component of the dosage form or any other allergy, which, in the opinion of the Investigator, contraindicates their participation.
  6. The subject has any clinically significant abnormal heart rate or blood pressure measurements, at the screening visit, which, in the opinion of the Investigator, prevent safe participation in the study. (dBP< 60mmHg or > 90mmHg, sBP < 95mmHg or > 160mmHg or HR < 40bpm or > 100bpm).
  7. Subjects with known history of urinary retention, severe gastrointestinal obstruction (including paralytic ileus or intestinal atony) or severe gastrointestinal conditions (including toxic megacolon or ulcerative colitis), myasthenia gravis, uncontrolled narrow angle glaucoma or shallow interior chamber or subjects deemed to be at risk for these conditions.
  8. Subjects undergoing haemodialysis or who have severe renal impairment.
  9. Subjects with severe hepatic impairment, defined as Child-Pugh grade IV.
  10. Subjects taking potent CYP 3A4 inhibitors which would, under normal circumstances, require adjustment of the dose of the test drugs.
  11. Subject has taken prescribed medication within 14 days prior to the first study day or over-the-counter medicine (including vitamins and herbal remedies) within 48 hours prior to the first study day, which in the opinion of the Investigator, will interfere with the study procedures or compromise safety.
  12. Subject has an average weekly alcohol intake of greater than 21 units (male) or 14 units (female) within the 90 days prior to the study. 1 unit is 270cc of beer, 40cc of spirits or 125cc of wine.
  13. History of smoking more than 10 cigarettes (or the equivalent amount of tobacco) per day within the 90 days prior to the study.
  14. Subject has participated in any clinical study within the last 90 days.
  15. Any clinically significant abnormality following Investigator review of the pre study physical examination.
  16. Any clinical condition, which, in the opinion of the Investigator, would not allow safe completion of the study.
  17. Any subjects who, in the opinion of the investigator, may find it difficult to adhere to the provisions of treatment and observation specified in the protocol.

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: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Fesoterodine 4mg daily
fesoterodine 4mg oral
Drug: fesoterodine 4mg
7 days therapy followed by seven days washout. Each 4mg tablet is taken in the morning
Other Names:
  • Toviaz
Drug: Oxybutynin
5mg IR oxybutynin taken bid, encapsulated into a form indistinguishable from placebo
Other Names:
  • ditropan
Drug: placebo
placebo capsule, one twice daily, and 2 placebo fesoterodine tablets taken each morning for masking and comparator purposes
Other Names:
  • placebo capsule
Drug: fesoterodine 8mg
2, 4mg fesoterodine capsules taken together in the morning
Other Names:
  • Toviaz 8mg
Experimental: Fesoterodine 8mg
Fesoterodine 8mg in form of 2, 4mg tablets
Drug: fesoterodine 4mg
7 days therapy followed by seven days washout. Each 4mg tablet is taken in the morning
Other Names:
  • Toviaz
Drug: Oxybutynin
5mg IR oxybutynin taken bid, encapsulated into a form indistinguishable from placebo
Other Names:
  • ditropan
Drug: placebo
placebo capsule, one twice daily, and 2 placebo fesoterodine tablets taken each morning for masking and comparator purposes
Other Names:
  • placebo capsule
Drug: fesoterodine 8mg
2, 4mg fesoterodine capsules taken together in the morning
Other Names:
  • Toviaz 8mg
Active Comparator: oxybutynin
oxybutynin immediate release, encapsulated 2, 5mg capsules daily
Drug: fesoterodine 4mg
7 days therapy followed by seven days washout. Each 4mg tablet is taken in the morning
Other Names:
  • Toviaz
Drug: Oxybutynin
5mg IR oxybutynin taken bid, encapsulated into a form indistinguishable from placebo
Other Names:
  • ditropan
Drug: placebo
placebo capsule, one twice daily, and 2 placebo fesoterodine tablets taken each morning for masking and comparator purposes
Other Names:
  • placebo capsule
Drug: fesoterodine 8mg
2, 4mg fesoterodine capsules taken together in the morning
Other Names:
  • Toviaz 8mg
Placebo Comparator: placebo capsule
placebo capsule, 2 per day
Drug: fesoterodine 4mg
7 days therapy followed by seven days washout. Each 4mg tablet is taken in the morning
Other Names:
  • Toviaz
Drug: Oxybutynin
5mg IR oxybutynin taken bid, encapsulated into a form indistinguishable from placebo
Other Names:
  • ditropan
Drug: placebo
placebo capsule, one twice daily, and 2 placebo fesoterodine tablets taken each morning for masking and comparator purposes
Other Names:
  • placebo capsule
Drug: fesoterodine 8mg
2, 4mg fesoterodine capsules taken together in the morning
Other Names:
  • Toviaz 8mg

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
continuity of attention
Time Frame: 1 and 4h post dose

Continuity of Attention:

Accuracy of responding in Choice Reaction Time task Percent Target Detection in Digit Vigilance task False Alarms in Digit Vigilance task
1 and 4h post dose

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
cognitive function
Time Frame: 1 and 4h post last dose of study drug

includes the following domains of cognition

  • power of attention,
  • quality of working memory,
  • quality of episodic secondary memory,
  • speed of memory
  • Montreal Cognitive assessment score
1 and 4h post last dose of study drug

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Alberta

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Pfizer

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Adrian S Wagg, MD, University of Alberta

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 11, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 12, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 15, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 19, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 18, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FES-COG 1808

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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