A Study to Assess the Cognitive Effects of Fesoterodine in Elderly Subjects

Study Overview
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Brief Summary
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The study is designed to evaluate elements of cognitive function in subjects receiving either fesoterodine or alprazolam.

Detailed Description
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Evaluation of cognitive function

Official Title
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A 4 Way Placebo And Active Controlled Study To Evaluate The Effects Of Fesoterodine On Cognitive Function In Healthy Elderly Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: 4mg fesoterodine
* Drug: 8mg fesoterodine
* Drug: alprazolam 1mg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult healthy volunteers 65 years and over with minimum MMSE of 26 Exclusion Criteria: Prohibited concomitant medications Confounding medical conditions Clinically significant comorbid diseases Hypersensitivity or contraindications to fesoterodine or active control

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 4mg fesoterodine<br> | Drug: 4mg fesoterodine<br>* 4mg tablet once daily for 6 days<br>|
| Experimental: fesoterodine 8mg<br> | Drug: 8mg fesoterodine<br>* 4mg tablet once daily for 3 days followed by 8mg tablet once daily for 3 days<br>|
| Active Comparator: 1mg alprazolam<br> | Drug: alprazolam 1mg<br>* 1mg tablet once on last day of treatment period at clinic<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo tablet for fesoterodine once daily for 6 days and placebo tablet for alprazolam once on last day of treatment period at clinic<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Computer Based Objective Cognition Testing (CogState) Detection Speed | Detection speed: a cognitive test which assessed psychomotor function. A playing card was presented face up in the center of the screen. As soon as this happened, the participant was to press the 'Yes' key. The outcome measure was speed of performance; mean of the log10 transformed reaction time for correct responses [measured in log10 milliseconds (MS)]. Lower scores meant a better performance. | Baseline | 
| Change From Baseline in Computer Based Objective Cognition Testing (CogState) Detection Speed on Day 6 | Detection speed: a cognitive test which assessed psychomotor function. A playing card was presented face up in the center of the screen. As soon as this happened, the participant was to press the 'Yes' key. The outcome measure was speed of performance; mean of the log10 transformed reaction time for correct responses [measured in log10 milliseconds (MS)]. Lower scores meant a better performance. | Baseline and Day 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CogState Identification Speed | Identification speed: a cognitive test which assessed visual attention. A playing card was presented face up in the center of the screen. As soon as this happened, the participant had to decide whether the card was red or not. The outcome measure was speed of performance; mean of the log10 transformed reaction time for correct responses (measured in log10 MS). Lower scores meant a better performance. | Baseline | 
| Change From Baseline in CogState Identification Speed on Day 6 | Identification speed: a cognitive test which assessed visual attention. A playing card was presented face up in the center of the screen. As soon as this happened, the participant had to decide whether the card was red or not. The outcome measure was speed of performance; mean of the log10 transformed reaction time for correct responses (measured in log10 MS). Lower scores meant a better performance. | Baseline and Day 6 | 
| CogState One Card Learning | One card learning: a cognitive test which assessed visual learning. Participants were to remember which cards were previously shown in a task. The outcome measure was accuracy of performance; arcsine transformation of the square root (sqrt) of the proportion of correct responses. Higher scores meant a better performance. | Baseline | 
| Change From Baseline in CogState One Card Learning on Day 6 | One card learning: a cognitive test which assessed visual learning. Participants were to remember which cards were previously shown in a task. The outcome measure was accuracy of performance; arcsine transformation of the square root (sqrt) of the proportion of correct responses. Higher scores meant a better performance. | Baseline and Day 6 | 
| CogState Continuous Paired Associate Learning (CPAL) | CPAL: a cognitive test which assessed visual episodic learning. Participant was to learn and remember picture locations on the screen and was to tap the target on the central location to begin. As each picture was revealed, the participant was to remember where the picture was located and tap that location. The outcome measure was the number of errors made in correctly placing each of the 4 patterns in their location 4 times. Lower scores meant a better performance. | Baseline | 
| Change From Baseline in CogState CPAL on Day 6 | CPAL: a cognitive test which assessed visual episodic learning. Participant was to learn and remember picture locations on the screen and was to tap the target on the central location to begin. As each picture was revealed, the participant was to remember where the picture was located and tap that location. The outcome measure was the number of errors made in correctly placing each of the 4 patterns in their location 4 times. Lower scores meant a better performance. | Baseline and Day 6 | 
| CogState Groton Maze Learning Task (GMLT) | GMLT: a cognitive test which assessed executive function. Participant was shown a 10 x 10 grid of tiles on a computer touch screen. A 28-step pathway was hidden among 100 possible locations. The participant was instructed to move 1 step from the start location and then continue 1 tile at a time, toward the end to find the pathway. The outcome measure was total number of errors made in attempting to learn the same hidden pathway on 5 consecutive trials at a single session. Lower scores meant a better performance. | Baseline | 
| Change From Baseline in CogState Groton Maze Learning Task on Day 6 | GMLT: a cognitive test which assessed executive function. Participant was shown a 10 x 10 grid of tiles on a computer touch screen. A 28-step pathway was hidden among 100 possible locations. The participant was instructed to move 1 step from the start location and then continue 1 tile at a time, toward the end to find the pathway. The outcome measure was total number of errors made in attempting to learn the same hidden pathway on 5 consecutive trials at a single session. Lower scores meant a better performance. | Baseline and Day 6 | 
| Rey Auditory Verbal Learning Test (RAVLT) | RAVLT evaluates a wide diversity of functions: short-term auditory-verbal memory, rate of learning, learning strategies, retroactive, and proactive interference, presence of confabulation of confusion in memory processes, retention of information, and differences between learning and retrieval. Assessment of RAVLT is between 10 to 15 minutes; Performance variable: the sum of the number of words recalled successfully on the delayed recall trial. Higher score meant a better performance. | Baseline | 
| Rey Auditory Verbal Learning Test (RAVLT) on Day 6 | RAVLT evaluates a wide diversity of functions: short-term auditory-verbal memory, rate of learning, learning strategies, retroactive, and proactive interference, presence of confabulation of confusion in memory processes, retention of information, and differences between learning and retrieval. Assessment of RAVLT is between 10 to 15 minutes; Performance variable: the sum of the number of words recalled successfully on the delayed recall trial. Higher score meant a better performance. | Baseline and Day 6 |