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

NCT02240459 | Completed Phase 2

• 1 other identifier: FES-COG 1808
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Overactive Bladder; Mild Cognitive Impairment

Keywords

crossover study; placebo controlled; double blind; overactive bladder

Outcome Measures

Primary Outcomes (1)

• continuity of attention

  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 Outcomes (1)

• cognitive function

  1 and 4h post last dose of study drug

Study Arms (4)

Fesoterodine 4mg daily

EXPERIMENTAL

fesoterodine 4mg oral

Drug: fesoterodine 4mg; Drug: Oxybutynin; Drug: placebo; Drug: fesoterodine 8mg

Fesoterodine 8mg

EXPERIMENTAL

Fesoterodine 8mg in form of 2, 4mg tablets

Drug: fesoterodine 4mg; Drug: Oxybutynin; Drug: placebo; Drug: fesoterodine 8mg

oxybutynin

ACTIVE COMPARATOR

oxybutynin immediate release, encapsulated 2, 5mg capsules daily

Drug: fesoterodine 4mg; Drug: Oxybutynin; Drug: placebo; Drug: fesoterodine 8mg

placebo capsule

PLACEBO COMPARATOR

placebo capsule, 2 per day

Drug: fesoterodine 4mg; Drug: Oxybutynin; Drug: placebo; Drug: fesoterodine 8mg

Interventions

fesoterodine 4mg DRUG

7 days therapy followed by seven days washout. Each 4mg tablet is taken in the morning

Also known as: Toviaz

Fesoterodine 4mg daily; Fesoterodine 8mg; oxybutynin; placebo capsule

Oxybutynin DRUG

5mg IR oxybutynin taken bid, encapsulated into a form indistinguishable from placebo

Also known as: ditropan

Fesoterodine 4mg daily; Fesoterodine 8mg; oxybutynin; placebo capsule

placebo DRUG

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

Also known as: placebo capsule

Fesoterodine 4mg daily; Fesoterodine 8mg; oxybutynin; placebo capsule

fesoterodine 8mg DRUG

2, 4mg fesoterodine capsules taken together in the morning

Also known as: Toviaz 8mg

Fesoterodine 4mg daily; Fesoterodine 8mg; oxybutynin; placebo capsule

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• The subject is either male or female and ≥ 75 years of age.
• The subject has OAB as determined by ICS criteria
• The subject has mild cognitive impairment as determined by NIA criteria
• The subject is competent to give informed consent and perform the tasks associated with the study
• The subject has a body mass index (BMI) between 18.0 to 30.0 kg/m2 inclusive.
• Written informed consent has been obtained.
• The subject is available to complete the study.
• 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.

You may not qualify if:

• The subject does not have OAB.
• The subject has either dementia or moderate to severe cognitive impairment at screening.
• The subject has probable clinical depression as determined by Geriatric Depression Scale (GDS) short form \>5 at screening.
• Subjects taking any cognitive enhancers (cholinesterase inhibitors or memantine).
• 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.
• 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).
• 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.
• Subjects undergoing haemodialysis or who have severe renal impairment.
• Subjects with severe hepatic impairment, defined as Child-Pugh grade IV.
• Subjects taking potent CYP 3A4 inhibitors which would, under normal circumstances, require adjustment of the dose of the test drugs.
• 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.
• 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.
• History of smoking more than 10 cigarettes (or the equivalent amount of tobacco) per day within the 90 days prior to the study.
• Subject has participated in any clinical study within the last 90 days.
• Any clinically significant abnormality following Investigator review of the pre study physical examination.

Sponsors & Collaborators

• University of Alberta: lead
• Pfizer: collaborator

Study Sites (1)

Division of Geriatric Medicine, Clinical Sciences Building, University of Alberta Hosp

Edmonton, Alberta, T6G 2P4, Canada

Location

Related Publications (2)

• 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.

  PMID: 23332882 BACKGROUND

• 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.

  PMID: 19747069 BACKGROUND

MeSH Terms

Conditions

Urinary Bladder, Overactive; Cognitive Dysfunction

Interventions

fesoterodine; oxybutynin

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Adrian S Wagg, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Chair in Healthy Aging

Study Record Dates

• First Submitted: September 11, 2014
• First Posted: September 15, 2014
• Study Start: August 1, 2016
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2020
• Last Updated: February 19, 2020

Record last verified: 2020-02

Locations

CA (1)