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

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ClinicalTrials.gov Identifier: NCT02240459
Recruitment Status : Completed
First Posted : September 15, 2014
Last Update Posted : February 19, 2020
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Adrian Wagg, University of Alberta

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Overactive Bladder Mild Cognitive Impairment Drug: fesoterodine 4mg Drug: Oxybutynin Drug: placebo Drug: fesoterodine 8mg Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: 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
Study Start Date : August 2016
Actual Primary Completion Date : January 31, 2020
Actual Study Completion Date : January 31, 2020


Arm Intervention/treatment
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 Name: Toviaz

Drug: Oxybutynin
5mg IR oxybutynin taken bid, encapsulated into a form indistinguishable from placebo
Other Name: ditropan

Drug: placebo
placebo capsule, one twice daily, and 2 placebo fesoterodine tablets taken each morning for masking and comparator purposes
Other Name: placebo capsule

Drug: fesoterodine 8mg
2, 4mg fesoterodine capsules taken together in the morning
Other Name: 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 Name: Toviaz

Drug: Oxybutynin
5mg IR oxybutynin taken bid, encapsulated into a form indistinguishable from placebo
Other Name: ditropan

Drug: placebo
placebo capsule, one twice daily, and 2 placebo fesoterodine tablets taken each morning for masking and comparator purposes
Other Name: placebo capsule

Drug: fesoterodine 8mg
2, 4mg fesoterodine capsules taken together in the morning
Other Name: 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 Name: Toviaz

Drug: Oxybutynin
5mg IR oxybutynin taken bid, encapsulated into a form indistinguishable from placebo
Other Name: ditropan

Drug: placebo
placebo capsule, one twice daily, and 2 placebo fesoterodine tablets taken each morning for masking and comparator purposes
Other Name: placebo capsule

Drug: fesoterodine 8mg
2, 4mg fesoterodine capsules taken together in the morning
Other Name: 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 Name: Toviaz

Drug: Oxybutynin
5mg IR oxybutynin taken bid, encapsulated into a form indistinguishable from placebo
Other Name: ditropan

Drug: placebo
placebo capsule, one twice daily, and 2 placebo fesoterodine tablets taken each morning for masking and comparator purposes
Other Name: placebo capsule

Drug: fesoterodine 8mg
2, 4mg fesoterodine capsules taken together in the morning
Other Name: Toviaz 8mg




Primary Outcome Measures :
  1. 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



Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02240459


Locations
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Canada, Alberta
Division of Geriatric Medicine, Clinical Sciences Building, University of Alberta Hosp
Edmonton, Alberta, Canada, T6G 2P4
Sponsors and Collaborators
University of Alberta
Pfizer
Investigators
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Principal Investigator: Adrian S Wagg, MD University of Alberta
Publications:
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Responsible Party: Adrian Wagg, Research Chair in Healthy Aging, University of Alberta
ClinicalTrials.gov Identifier: NCT02240459    
Other Study ID Numbers: FES-COG 1808
First Posted: September 15, 2014    Key Record Dates
Last Update Posted: February 19, 2020
Last Verified: February 2020
Keywords provided by Adrian Wagg, University of Alberta:
crossover study
placebo controlled
double blind
overactive bladder
Additional relevant MeSH terms:
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Urinary Bladder, Overactive
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Fesoterodine
Oxybutynin
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents