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

NCT02240459

Last updated date
Study Location
Division of Geriatric Medicine, Clinical Sciences Building, University of Alberta Hosp
Edmonton, Alberta, T6G 2P4, Canada
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Overactive Bladder, Mild Cognitive Impairment
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
75 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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.

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Overactive Bladder, Mild Cognitive ImpairmentA Study of Fesoterodine and Oxybutynin on Cognitive Function in Mild Cognitive Impairment
NCT02240459
  1. Edmonton, Alberta
ALL GENDERS
75 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Study of Fesoterodine and Oxybutynin on Cognitive Function in Mild Cognitive Impairment
Official Title  ICMJE 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
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE
  • Overactive Bladder
  • Mild Cognitive Impairment
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Fesoterodine 4mg daily
    fesoterodine 4mg oral
    Interventions:
    • Drug: fesoterodine 4mg
    • Drug: Oxybutynin
    • Drug: placebo
    • Drug: fesoterodine 8mg
  • Experimental: Fesoterodine 8mg
    Fesoterodine 8mg in form of 2, 4mg tablets
    Interventions:
    • Drug: fesoterodine 4mg
    • Drug: Oxybutynin
    • Drug: placebo
    • Drug: fesoterodine 8mg
  • Active Comparator: oxybutynin
    oxybutynin immediate release, encapsulated 2, 5mg capsules daily
    Interventions:
    • Drug: fesoterodine 4mg
    • Drug: Oxybutynin
    • Drug: placebo
    • Drug: fesoterodine 8mg
  • Placebo Comparator: placebo capsule
    placebo capsule, 2 per day
    Interventions:
    • Drug: fesoterodine 4mg
    • Drug: Oxybutynin
    • Drug: placebo
    • Drug: fesoterodine 8mg
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 18, 2020)
47
Original Estimated Enrollment  ICMJE
 (submitted: September 12, 2014)
50
Actual Study Completion Date  ICMJE January 31, 2020
Actual Primary Completion Date January 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 75 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02240459
Other Study ID Numbers  ICMJE FES-COG 1808
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Adrian Wagg, University of Alberta
Study Sponsor  ICMJE University of Alberta
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Adrian S Wagg, MDUniversity of Alberta
PRS Account University of Alberta
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP