DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

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

Information source: University of Alberta
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Overactive Bladder; Mild Cognitive Impairment

Intervention: fesoterodine 4mg (Drug); Oxybutynin (Drug); placebo (Drug); fesoterodine 8mg (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: University of Alberta

Official(s) and/or principal investigator(s):
Adrian S Wagg, MD, Principal Investigator, Affiliation: University of Alberta

Overall contact:
Adrian S Wagg, MD, Phone: 780 492 5338, Email: adrian.wagg@ualberta.ca


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.

Clinical Details

Official title: A Phase IV Cross Over Study of Fesoterodine and Oxybutynin Versus Placebo on Cognitive Function in Subjects With Overactive Bladder and Mild Cognitive Impairment

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Primary outcome: continuity of attention

Secondary outcome: cognitive function

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


Minimum age: 75 Years. Maximum age: N/A. Gender(s): Both.


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.

Locations and Contacts

Adrian S Wagg, MD, Phone: 780 492 5338, Email: adrian.wagg@ualberta.ca

Division of Geriatric Medicine, Clinical Sciences Building, University of Alberta Hosp, Edmonton, Alberta T6G 2P4, Canada; Not yet recruiting
Adrian Wagg, MD, Phone: 780 492 5338, Email: adrian.wagg@ualberta.ca
Saima Rajabali, MBBS, Phone: 780 492 3700, Email: srajabal@ualberta.ca
Adrian S Wagg, MD, Principal Investigator
Saima Rajabali, MBBS, Sub-Investigator
William Gibson, MBBS, Sub-Investigator
Additional Information

Related publications:

Wagg A, Dale M, Tretter R, Stow B, Compion G. Randomised, multicentre, placebo-controlled, double-blind crossover study investigating the effect of solifenacin and oxybutynin in elderly people with mild cognitive impairment: the SENIOR study. Eur Urol. 2013 Jul;64(1):74-81. doi: 10.1016/j.eururo.2013.01.002. Epub 2013 Jan 11.

Wesnes KA, Edgar C, Tretter RN, Bolodeoku J. Exploratory pilot study assessing the risk of cognitive impairment or sedation in the elderly following single doses of solifenacin 10 mg. Expert Opin Drug Saf. 2009 Nov;8(6):615-26. doi: 10.1517/14740330903260790.

Starting date: August 2015
Last updated: May 13, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017