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

• Computer Based Objective Cognition Testing (CogState) Detection Speed [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  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.
  
  
• Change From Baseline in Computer Based Objective Cognition Testing (CogState) Detection Speed on Day 6 [ Time Frame: Baseline and Day 6 ] [ Designated as safety issue: No ]
  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.
  
  

• CogState Identification Speed [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  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.
  
  
• Change From Baseline in CogState Identification Speed on Day 6 [ Time Frame: Baseline and Day 6 ] [ Designated as safety issue: No ]
  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.
  
  
• CogState One Card Learning [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  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.
  
  
• Change From Baseline in CogState One Card Learning on Day 6 [ Time Frame: Baseline and Day 6 ] [ Designated as safety issue: No ]
  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.
  
  
• CogState Continuous Paired Associate Learning (CPAL) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  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.
  
  
• Change From Baseline in CogState CPAL on Day 6 [ Time Frame: Baseline and Day 6 ] [ Designated as safety issue: No ]
  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.
  
  
• CogState Groton Maze Learning Task (GMLT) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  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.
  
  
• Change From Baseline in CogState Groton Maze Learning Task on Day 6 [ Time Frame: Baseline and Day 6 ] [ Designated as safety issue: No ]
  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.
  
  
• Rey Auditory Verbal Learning Test (RAVLT) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  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.
  
  
• Rey Auditory Verbal Learning Test (RAVLT) on Day 6 [ Time Frame: Baseline and Day 6 ] [ Designated as safety issue: No ]
  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.
  
  

Evaluation of cognitive function