Skip to main content
OpenTrials
Completed

NCT Number: NCT01161472

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

65 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site, Overland Park, Kansas, United States

Loading trial locations.

About this study

Evaluation of cognitive function

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

4mg fesoterodine

Drug

4mg tablet once daily for 6 days

8mg fesoterodine

Drug

4mg tablet once daily for 3 days followed by 8mg tablet once daily for 3 days

alprazolam 1mg

Drug

1mg tablet once on last day of treatment period at clinic

Placebo

Drug

Placebo tablet for fesoterodine once daily for 6 days and placebo tablet for alprazolam once on last day of treatment period at clinic

Primary outcomes

  1. Computer Based Objective Cognition Testing (CogState) Detection Speed

    Time frame: Baseline

    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.

  2. Change From Baseline in Computer Based Objective Cognition Testing (CogState) Detection Speed on Day 6

    Time frame: Baseline and 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.

Secondary outcomes

  1. CogState Identification Speed

    Time frame: Baseline

    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.

  2. Change From Baseline in CogState Identification Speed on Day 6

    Time frame: Baseline and 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.

  3. CogState One Card Learning

    Time frame: Baseline

    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.

  4. Change From Baseline in CogState One Card Learning on Day 6

    Time frame: Baseline and 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.

  5. CogState Continuous Paired Associate Learning (CPAL)

    Time frame: Baseline

    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.

  6. Change From Baseline in CogState CPAL on Day 6

    Time frame: Baseline and 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.

  7. CogState Groton Maze Learning Task (GMLT)

    Time frame: Baseline

    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.

  8. Change From Baseline in CogState Groton Maze Learning Task on Day 6

    Time frame: Baseline and 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.

  9. Rey Auditory Verbal Learning Test (RAVLT)

    Time frame: Baseline

    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.

  10. Rey Auditory Verbal Learning Test (RAVLT) on Day 6

    Time frame: Baseline and 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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jul 13, 2010
Registry last updated
Jun 28, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.